TITLE: Dental Space Maintainers for the Management of Premature Loss of Deciduous

Molars: A Review of the Clinical Effectiveness, Cost-effectiveness and

Guidelines

DATE: 20 October 2016

CONTEXT AND POLICY ISSUES

Premature loss of primary teeth in children may lead to changes to the permanent dentition
including malocclusion and dental arch issues due to drifting teeth. Dental space maintainers
(SMs) are commonly used to preserve alignment of the existing dental arch, and to preserve
space for unerupted teeth. Broadly, there are two categories of SMs: fixed, which are cemented
to one or more teeth, and removable, which are not cemented and can be taken out of the oral
cavity. They can be constructed of different materials such as stainless steel wire, or glass fiber-
reinforced composite resin (GFRCR). They can be placed on the mandibular or maxillary arch.
Examples of SMs include band and loop, lingual arch, palatal arch, and crown-loop.

Given suggestions by dental associations for their use among children for primary teeth loss,1 it
is important to understand the clinical evidence and costs associated with SMs, as well as to
look to evidence-based guidelines on appropriate use. Potential benefits include reduction of
crowding, ectopic eruption, crossbite, excessive overbite and overjet, and poor molar
relationship.2 However, SMs can increase plaque accumulation, decrease periodontal health,
and increase oral microflora.3

The purpose of this review is to examine the clinical effectiveness, cost-effectiveness, and
guideline recommendations surrounding the types and use of SMs.

RESEARCH QUESTIONS

1. What is the clinical effectiveness of space maintainers in the management of premature

loss of deciduous molars (primary teeth)?

2. What is the comparative clinical effectiveness of different types of space maintainers in

the management of premature loss of deciduous molars (primary teeth)?

Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in
Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic review s. The intent is to
provide a list of sources of the best evidence on the topic that the Canadian Agency for Drugs and Technologies in Health (CADTH)
could identify using all reasonable efforts within the time allow ed. Rapid responses should be considered along w ith other ty pes of
information and health care considerations. The information included in this response is not intended to replace professional medical
advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also
cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and
emerging health technologies, for w hich little information can be found, but w hich may in future prove to be effective. While CADTH
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3. What is the comparative effectiveness of space maintainers placed by specialists versus
general practitioners?

4. What is the cost-effectiveness of space maintainers for the management of premature

loss of deciduous molars (primary teeth)?

5. What are the evidence-based guidelines regarding the use of space maintainers?

KEY FINDINGS

One quasi-randomized controlled trial, three controlled clinical trials, and four observational
studies were reviewed on the clinical effectiveness of space maintainers (SMs) in the
management of premature loss of primary teeth in children. No economic evaluations or
evidence-based guidelines were retrieved on the topic.

Comparing patients with and without SMs, studies reported that patients with SMs had more
frequent eruption difficulties, but no difference in space loss. Other studies compared different
types of SMs including band and loop, lingual holding arch, and glass fiber-reinforced composite
resin maintainers. Most types appeared to fare similarly in terms of gingival health and
proportion of patients developing caries.

METHODS

Literature Search Methods

A limited literature search was conducted on key resources including PubMed, The Cochrane
Library, University of York Centre for Reviews and Dissemination (CRD) databases, ECRI
Institute, Canadian and major international health technology agencies, as well as a focused
Internet search. No filters were applied to limit retrieval by publication type. Where possible,
retrieval was limited to the human population. The search was also limited to English language
documents published between January 1, 2006 and September 21, 2016.

Selection Criteria and Methods

One reviewer screened citations and selected studies. In the first level of screening, titles and
abstracts were reviewed and potentially relevant articles were retrieved and assessed for
inclusion. The final selection of full-text articles was based on the inclusion criteria presented in
Table 1.

Dental Space Maintainers 2

 Table 1: Selection Criteria
Population Pediatric patients (age 0-18) with primary or mixed dentition, with
premature loss of deciduous molars (primary teeth)
Intervention Dental space maintainers
Comparator No space maintainer; different types of space maintainers
Outcomes Clinical effectiveness (e.g. prevention of change in the arch
length/space, prevention malocclusion (e.g. ectopic eruptions,
rotations, crowding, spacing, crossbite, overbite, overjet, impactions,
midline shifts), cost-effectiveness, guidelines (including indications,
recommendations on type of space maintainer, and type of
practitioner)
Study Designs HTA/Systematic Reviews/Meta-Analyses
Randomized Controlled Trials
Economic Evaluations
Non-Randomized Studies
Guidelines

Exclusion Criteria

Articles were excluded if they did not meet the selection criteria outlined in Table 1, were
duplicate publications, or were published prior to 2011. Guidelines were excluded if they were
not evidence-based, or were superseded by more recent publications. Systematic reviews were
excluded if only one database was searched, or if only one reviewer selected and assessed the
studies.4

Critical Appraisal of Individual Studies

For critical appraisal of the included controlled trials and observational studies, the Downs and
Black instrument was used.5 Summary scores were not calculated for the included studies;
rather, a review of the strengths and limitations of each included study were described.

SUMMARY OF EVIDENCE

Quantity of Research Available

A total of 250 citations were identified in the literature search. Following screening of titles and
abstracts, 229 citations were excluded and 21 potentially relevant reports from the electronic
search were retrieved for full-text review. No additional citations were retrieved from the grey
literature search. Of these potentially relevant articles, 13 publications were excluded: one
enrolled an irrelevant population, three evaluated irrelevant outcomes, six were irrelevant study
designs, and three did not include a comparator. Eight publications met the inclusion criteria and
were included in this report. Appendix 1 describes the PRISMA flowchart of the study selection.

Additional references of potential interest are provided in Appendix 5.

Summary of Study Characteristics

A detailed description of individual study characteristics is provided in Appendix 2.

Dental Space Maintainers 3

Study Design
One study was a quasi-randomized controlled trial (RCT),6 three were controlled clinical trials
(CCT),7-9 and the remaining four were observational studies.10-13 No evidence-based guidelines,
systematic reviews, or economic evaluations were identified.

Owais et al. was classified as quasi-RCT because the investigators used alternation as a
method of SM treatment assignment. Setia et al.,7 Subramaniam et al.,9 and Nidhi et al.8 were
classified as CCTs because the investigators “[did] not state explicitly that the trial was
randomized, but randomization [could] not be ruled out”.4 Studies were classified as
observational if the investigators did not explicitly report actively introducing a treatment.
Specifically, the observational studies were cohort studies, of which one was retrospective,11
one was prospective,13 and two were unspecified.10,12

Setting
Three studies (38%) were from India,7-9 one from Jordan (13%),6 one from the United States
(13%),13 and three (38%) were unknown.10-12 From the studies that reported settings, all were
single centre studies except for Rubin et al., which enrolled participants from three centres.13
The settings varied from an outpatient centre,7 to a teaching hospital,9 to private orthodontic
practices.13 None were reported to be from remote settings.

Patient Population
Patients were pediatric patients, with mean ages of 10 years or under, and ranges between two
to 12 years of age. Ethnicity was not provided in any study, except one that recruited all
Caucasian children.12 Inclusion criteria generally required healthy patients with loss of primary
teeth during mixed dentition,6,11-13 and no congenitally missing teeth.8-11 Two studies exclusively
considered mandibular arches,6,13 while others accepted mandibular and maxillary arches.7,10,11

Interventions and Comparators

The most common SM examined was band and loop (5 studies, 63%). 7-11 Four studies 6,11-13
examined lingual arch appliances, while three studies 7-9 examined glass fiber-reinforced
composite resin (GFRCR) maintainers including Ribbond7 and Super splint.7

Two studies compared use of SMs versus no dental SM.11,12 Four studies compared different
types of SMs to each other.7-10 Two studies compared different types of SMs to each other as
well as to no SM.6,13 In terms of the placement of SMs, five studies had comparators placed in
separate groups of patients, so that comparisons were made between patients.6,10-13 Three
studies had different SM comparators placed either in different quadrants of the mouth,8,9 or in
different extraction sites of the mouth,7 so that comparisons were made within patients.

Outcomes
Several studies examined the presence of caries,7-9 and gingival health, which was evaluated
either as an index score,10 or as the presence of gingival inflammation.8,9 One study examined
tooth eruption difficulty.13 The remaining studies examined cephalometric measurements from
radiographs including sagittal variation in incisors,12 arch dimensions,6 and space loss.11

Summary of Critical Appraisal

A summary of critical appraisal of individual studies can be found in Appendix 3.

Dental Space Maintainers 4

The quality of evidence was generally low. Among the clinical trials, one used a quasi-random
method of treatment assignment.6 Three were unclear as to whether a random or non-random
method of treatment assignment was used.7-9 Not assigning treatments in a random manner
introduces selection bias, whereby there may be imbalances in prognostic variables between
treatment groups. The quasi-RCT and CCTs did not conceal allocation methods. Given the
nature of orthodontic treatments, blinding was not possible. Biases from lack of blinding may
have been minimized, however, since outcome measurements were objective. None of the
clinical trials provided sample size calculations to ensure they were sufficiently powered to
detect treatment effects. It is unclear if statistically non-significant results 6,7 were due to a lack of
power or a true lack of effect.

Among the included studies, three addressed the issue of confounding.8,9,13 Confounding
occurs when the outcomes observed may not be a result of SM treatment, but rather a result of
other factors such as patient compliance or the child’s cooperativity. Two CCTs applied two
different SMs to the same patients, so that patients acted as their own controls.8,9 One
observational study controlled for known confounders within the statistical model.13

Across all studies, the most common follow-up times were 12 months or less,7-10 with the
longest being 48 months.11 Other studies followed patients to the end or after SM treatment, 6,13
or after eruption of permanent teeth,12 but they did not report the actual follow-up time. Six of the
eight studies enrolled fewer than 50 patients or extraction sites per comparator.6-10,12

Overall, reporting was poor across all studies. Five of the eight studies did not report details of
recruitment.6,8,10-12 Patient populations and settings were also poorly reported. Four studies
reported gender.9,10,12,13 One did not report age.12 Other patient characteristics such as rurality
were not described in any of the studies. In three studies, the country of origin and clinical
setting were unknown.10-12

Summary of Findings

Detailed findings from each individual study can be found in Appendix 4.

1. What is the clinical effectiveness of space maintainers in the management of premature

loss of deciduous molars (primary teeth)?

Four studies examined SM versus no SM as part of their comparisons. 6,11-13 There was no
description of the care provided for patients who did not receive SMs. In one study, SMs
(Schwarz appliance, lingual holding arch, or combination) were associated with greater odds of
eruption difficulty after adjusting for confounding (odds ratio not reported; P = 0.026).13 In terms
of cephalometric measurements, Letti et al. found the position of the lower incisors changed
more in patients with SMs (lingual arch) than patients without. 12 Specifically, patients with SMs
had significantly different linear distances between the most prominent portion of the lower
incisor crown and the NB line (P = 0.002), and had significantly different angles between the
long axis of lower incisor and the NB line (P = 0.000). Owais et al. found the inclination of the
lower incisors to the mandibular plane was increased in patients with SMs (lingual arch, 0.9 mm
or 1.25 mm wire), and the differences were statistically significant compared to patients without
SMs (P ≤ 0.01 for 0.9 mm SM, and P ≤ 0.05 for 1.25 mm SM).6 Alnahwi et al. found no
differences in space loss between patients with SM (any type) and without SM (no P-values
reported).11

Dental Space Maintainers 5

2. What is the comparative clinical effectiveness of different types of space maintainers in
the management of premature loss of deciduous molars?

Six studies compared different types of SMs.6-10,13 Patients did not develop caries throughout
follow-up for most SM types: Setia et al.7 reported no caries for four types of SMs (band and
loop, band and custom loop, Ribbond, and Super splint) over nine months; Subramaniam et al.9
reported none for two types of SMs (GFRCR, band and loop) over 12 months; and Nidhi et al.8
reported none for GFRCR over five months, and one case (6.25%) for band and loop. Arikan et
al.10 found plaque deposition was similar across most time points up to nine months for band
and loop SM compared to a removable SM (P > 0.05).

In terms of gingival health, Nidhi et al.8 reported no inflammation for GFRCR over five months,
and Subramaniam et al.9 reported no inflammation for GFRCR and band and loop over 12
months. Setia et al.7 noted no statistical differences in the proportion of patients with poor
gingival health receiving one of four types of SMs (band and loop, band and custom loop,
Ribbond, and Super splint) (P = 0.949). Arikan et al.10 found bleeding index scores and changes
in pocket depth scores differed between the band and loop SM, and removable SM over the
nine months of follow-up (P < 0.05). However, the data were presented as multiple
stratifications, and it was not possible to determine which SM was superior.

In terms of eruption difficulties, in one study, the lingual holding arch had the lowest proportion
of patients with problems (4.7%), and the combination of Schwarz appliance and lingual holding
arch had the highest (14.7%).13 No statistical comparisons were made.

In terms of cephalometric measurements, Owais et al.6 found no statistical differences between

the lingual holding arch made of 0.9 mm wire and one made of 1.25 mm wire (P > 0.05).

3. What is the comparative effectiveness of space maintainers placed by specialists versus

general practitioners?

No comparative data were available. Among included studies, there were no descriptions or
summary statistics on whether SMs were placed by specialists or general practitioners.

4. What is the cost-effectiveness of space maintainers for the management of premature

loss of deciduous molars?

No data were available.

5. What are the evidence-based guidelines regarding the use of space maintainers?

No data were available.

Limitations

This review identified a substantial literature gap in the management of premature loss of
primary teeth in children using SMs. No RCTs, systematic reviews, economic evaluations, or
evidence-based guidelines were retrieved. The robustness of the evidence outlined in this
review is limited due to the poor quality and poor reporting. Given the variation in the types of
SMs, the construction material, the placement of SMs, and the outcomes examined in the
included studies, consensus on the potential effects of SMs cannot be drawn.

Dental Space Maintainers 6

The extent to which the results could be applied externally is uncertain as a result of inadequate
reporting. For one, patient populations were not clearly described and sample sizes were small.
Among studies that described their settings, they were from single centres. None appeared to
be on Canadian populations.

CONCLUSIONS AND IMPLICATIONS FOR DECISION OR POLICY MAKING

One quasi-RCT, three CCTs and four observational studies were included and reviewed on the
use of SMs in children with premature loss of primary teeth. Only clinical effectiveness was
examined, including gingival health, presence of caries, plaque formation, eruption difficulties,
cephalometric measurements, and space loss. Studies did not examine cost-effectiveness or
guideline recommendations.

Overall, several methodological limitations and uncertain generalizability of the studies preclude
robust conclusions about the use of SMs.

PREPARED BY:
Canadian Agency for Drugs and Technologies in Health
Tel: 1-866-898-8439
www.cadth.ca

Dental Space Maintainers 7

REFERENCES

1. Guideline on management of the developing dentition and occlusion in pediatric dentistry.

In: 2015-16 Definitions, oral health policies, and clinical practice guidelines [Internet].
Chicago (IL): American Academy of Pediatric Dentistry (AAPD); 2015 Sep [cited 2016 Oct
18]. p. 253-65. Available from:
http://www.aapd.org/media/policies_guidelines/g_developdentition.pdf

2. Brothwell DJ. Guidelines on the use of space maintainers following premature loss of
primary teeth. J Can Dent Assoc. 1997 Nov;63(10):753, 757-66.

3. Arikan V, Kizilci E, Ozalp N, Ozcelik B. Effects of fixed and removable space maintainers
on plaque accumulation, periodontal health, candidal and enterococcus faecalis carriage.
Med Princ Pract. 2015;24(4):311-7.

4. Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions
[Internet]. Version 5.1.0. London (England): The Cochrane Collaboration; 2011 Mar. [cited
2016 Sep 27]. Available from: http://handbook.cochrane.org/

5. Downs SH, Black N. The feasibility of creating a checklist for the assessment of the
methodological quality both of randomised and non-randomised studies of health care
interventions. J Epidemiol Community Health [Internet]. 1998 Jun [cited 2016 Sep
27];52(6):377-84. Available from:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1756728/pdf/v052p00377.pdf

6. Owais AI, Rousan ME, Badran SA, Abu Alhaija ES. Effectiveness of a lower lingual arch
as a space holding device. Eur J Orthod [Internet]. 2011 Feb [cited 2016 Sep
27];33(1):37-42. Available from: http://ejo.oxfordjournals.org/content/eortho/33/1/37.full.pdf

7. Setia V, Kumar P, I, Srivastava N, Gugnani N, Gupta M. Banded vs bonded space

maintainers: finding better way out. Int J Clin Pediatr Dent [Internet]. 2014 May [cited 2016
Sep 27];7(2):97-104. Available from:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212165

8. Nidhi C, Jain RL, Neeraj M, Harsimrat K, Samriti B, Anuj C. Evaluation of the clinical
efficacy of glass fiber reinforced composite resin as a space maintainer and its
comparison with the conventional band and loop space maintainer. An in vivo study.
Minerva Stomatol. 2012 Jan;61(1-2):21-30.

9. Subramaniam P, Babu G, Sunny R. Glass fiber-reinforced composite resin as a space

maintainer: a clinical study. J Indian Soc Pedod Prev Dent. 2008;26(Suppl 3):S98-103.

10. Arikan F, Eronat N, Candan U, Boyacioglu H. Periodontal conditions associated with

space maintainers following two different dental health education techniques. J Clin
Pediatr Dent. 2007;31(4):229-34.

11. Alnahwi HH, Donly KJ, Contreras CI. Space loss following premature loss of primary
second molars. Gen Dent. 2015 Nov;63(6):e1-e4.

Dental Space Maintainers 8

12. Letti HC, Rizzatto SM, de Menezes LM, Reale CS, de Lima EM, Martinelli FL. Sagittal
changes in lower incisors by the use of lingual arch. Dental Press J Orthod. 2013
May;18(3):29-34.

13. Rubin RL, Baccetti T, McNamara JA Jr. Mandibular second molar eruption difficulties
related to the maintenance of arch perimeter in the mixed dentition. Am J Orthod
Dentofacial Orthop. 2012 Feb;141(2):146-52.

14. Loe H, Silness J. Periodontal disease in pregnancy. I. Prevalence and severity. Acta
Odontol Scand. 1963 Dec;21:533-51.

15. Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl
analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3.

Dental Space Maintainers 9

LIST OF ABBREVIATIONS

1.NB Angle between long axis of lower incisor and NB line

1-NB Linear distance mm between most prominent portion of the lower incisor crown
and NB line
ANOVA analysis of variance
CCT controlled clinical trial
GFRCR glass fiber-reinforced composite resin
IMPA angle between long axis of lower incisor and base of mandible
LLHA lower lingual holding arch
NR not reported
RCT randomized controlled trial
SE standard error
SM space maintainer
vs. versus

Dental Space Maintainers 10

APPENDIX 1: SELECTION OF INCLUDED STUDIES

250 citations identified from

electronic literature search and
screened

229 citations excluded

21 potentially relevant articles

retrieved for scrutiny (full text, if
available)

0 potentially relevant
reports retrieved from
other sources (grey
literature, hand
search)

21 potentially relevant reports

13 reports excluded:
-irrelevant population (1)
-irrelevant outcomes (3)
-irrelevant study design (6)
-no comparator (3)

8 reports included in review

Dental Space Maintainers 11

APPENDIX 2: CHARACTERISTICS OF INCLUDED PUBLICATIONS

Table A1: Characteristics of Included Clinical Studies

First Author, Study Design Patient Characteristics Type of space Comparator(s) Clinical
Publication Year, maintainer Outcomes,
Setting, Country Statistical
Analysis
7
Setia 2014, CCT: 32 children (range: 4 to 9 Band and loop (n= 1. Prefabricated Caries (Y/N);
years; gender NR) who 15 samples) band with custom
Outpatient centre, Extraction site as unit of either required extraction of made loop (n= 15 Plaque deposition
assignment the primary first/second samples) of the abutment
India molar or having pre- tooth using Silness
extracted primary first or 2. Ribbond (n= 15 and Loe index
14
second molar in any of the samples) (Good/ Fair/ Poor)
arches; Patients could have
single or multiple extraction 3. Super splint (n= Chi-square,
sites in maxillary or 15 samples) McNemar's test
mandibular arch (n= 60 (paired data for
samples) same patients)
8
Nidhi 2012, CCT: 20 normal, healthy, and Glass fiber- Band-and-loop in Caries or gingival
cooperative children (range: reinforced the other quadrant inflammation
Single centre, Split-mouth trial 4 to 9 years; gender NR) composite resin of mouth
who had premature loss of a (GFRCR) in one Chi square test;
India primary first molar in at least quadrant of mouth Fisher’s exact test
two quadrants

6
Owais 2011, Quasi-RCT: 67 children (mean age Lower lingual 1. LLHA made with Arch dimensions
approximately 10 years; holding arch (LLHA) 1.25 mm stainless
Single centre, Alternation used as gender NR) with made with 0.9 mm steel wire (n= 24) Analysis of variance
method of treatment late mixed dentition; One or stainless steel wire with Bonferroni
Jordan assignment; Parallel both mandibular primary (n= 20) 2. No treatment (n= correction
arms second molars indicated for 23)
extraction
9
Subramaniam CCT: 30 normal, healthy, and Glass fiber- Band and loop in the Caries or gingival
2008, cooperative children (range: reinforced other quadrant of inflammation
Split-mouth trial 6 to 8 years; 23% girls) who composite resin mouth (n= 30)

Dental Space Maintainers 12

 Table A1: Characteristics of Included Clinical Studies
First Author, Study Design Patient Characteristics Type of space Comparator(s) Clinical
Publication Year, maintainer Outcomes,
Setting, Country Statistical
Analysis
Teaching hospital, had premature loss of a (GFRCR) in one Chi square test;
primary first molar in at least quadrant of mouth Fisher’s exact test
India two quadrants (n= 30)

CCT = controlled clinical trial; GFRCR = glass fiber-reinforced composite resin; LLHA = low er lingual holding arch; RCT = randomized controlled trial

Dental Space Maintainers 13

 Table A2: Characteristics of Included Observational Studies
First Author, Study Patient Type of space Comparator(s) Clinical Outcomes,
Publication Design Characteristics maintainer Statistical Analysis
Year, Setting,
Country
Alnahwi11 2015, Cohort, 87 healthy children Space maintainer No space Space loss measured by
retrospective (range 2 to12 years; after primary maintainer bitewing and periapical
NR gender NR) in the second molar following the radiographs: measurements
primary or mixed extraction (n= 36 extraction of a were made from the mesial
dentition with no samples) primary second surface of the permanent
congenitally missing molar (n= 64 first molar (or the distal
or supernumerary Note: Mix of samples) surface of the primary
teeth; Patients could appliances were second molar if the
have maxillary or used (band and permanent first molar had
mandibular loop, lower lingual not erupted) to the distal
prematurely extracted holding arch, surface of the primary
primary second transpalatal arch, canine
molars (n= 100 and Nance holding
samples) appliance) Student's t-test

Note: Most
appliances were
placed in the first
two months of
extraction; 10
samples were
placed one to two
years after
extraction

Letti12 2013, Cohort, 44 Caucasian children Lingual arch No orthodontic/ Sagittal variation on the
unspecified with mixed dentition appliance made orthopedic lower incisors:
NR (age NR; 59% girls) with 0.9 mm treatment (n= 14) 1. Angle between long axis
stainless steel wire of lower incisor and base of
(n= 30) mandible (IMPA);

Dental Space Maintainers 14

 Table A2: Characteristics of Included Observational Studies
First Author, Study Patient Type of space Comparator(s) Clinical Outcomes,
Publication Design Characteristics maintainer Statistical Analysis
Year, Setting,
Country
2. Angle between long axis
of lower incisor and line NB
(1.NB)
3. Linear distance mm
between most prominent
portion of the lower incisor
crown and line NB (1-NB)

Student's t-test

Rubin13 2012, Cohort, Consecutively treated Schwarz appliance 1. Mandibular Eruption difficulty: root of
prospective children (mean age (n= 58) lingual holding arch the mandibular second
Three private about 9 years; 54% (n= 85) molar was at least 75%
orthodontic girls); Comparators formed, but the tooth
practices, were matched on age, 2. Combination of remained unerupted
but matching methods both appliances
United States were NR (Schwarz appliance Descriptive statistics;
used first then Logistic regression for
removed; predictors of eruption
mandibular lingual difficulty (controlling for age,
holding arch used angulation, retromolar
near end of mixed space)
dentition) (n=58)

3. Controls from
another study (n=
100)

Dental Space Maintainers 15

 Table A2: Characteristics of Included Observational Studies
First Author, Study Patient Type of space Comparator(s) Clinical Outcomes,
Publication Design Characteristics maintainer Statistical Analysis
Year, Setting,
Country
Arikan10 2007, Cohort, 56 healthy children Band and loop (n= Removable Gingival index (Lobone);
unspecified (mean age 8.2 years; 26) appliance (n= 26) Plaque index (Silness and
NR range: 7 to 10 years; Loe index; Turesky)14,15;
43% girls) who had Bleeding index scores;
early loss of primary Pocket depths
molars (maxillary or
mandibular)
ANOVA; Chi-square;
Fisher's exact

1.NB = angle betw een long axis of low er incisor and line NB; 1-NB = linear distance mm betw een most prominent portion of the low er incisor crown and line NB; ANOVA = analysis of
variance; GFRCR = glass fiber-reinforced composite resin; IMPA = angle betw een long axis of low er incisor and base of mandible; NR = not reported

Dental Space Maintainers 16

APPENDIX 3: CRITICAL APPRAISAL OF INCLUDED PUBLICATIONS

Table A3: Strengths and Limitations of Controlled Trials and Observational Studies using
Downs and Black5
First Author, Publication Strengths Limitations
Year, Study Design,
Comparators
Space maintainer (SM) vs. none:
Alnahwi11 2015  Long follow-up period (up  Did not describe recruitment
to 48 months)  Did not account for
Observational  Defined inclusion/ confounding
exclusion criteria  Grouped different
SM (mix of band and loop,  Defined outcomes appliances, which may have
lower lingual holding arch, different treatment effects
transpalatal arch, and into one comparator; did not
Nance holding appliance) report the proportion of each
vs. No SM SM type used
 Included patients who had
SM applied years after
primary second molar
extraction
 Small sample size
 Single centre
Letti12 2013  Used commonly accepted  Did not describe recruitment
cephalometric analyses to  Did not account for
Observational measure outcomes confounding
 Reported a study error in the
Lingual arch appliance vs. outcome measurements;
No SM measurements were taken
again and no significant
differences were found
(Student’s t test, p> 0.05)
 Results did not support
conclusions
 Poor reporting overall
 Single centre
Comparisons of different types of SM to each other:
Setia7 2014  Technique of each SM  Method of randomization not
application described described although there
CCT  Used commonly accepted was mention of SM
index for measuring “randomly placed” in
Band and loop vs. Band and plaque deposition as an extraction sites
custom loop vs. Ribbond vs. outcome  No information on
Super splint concealment of allocation
 No power calculation
 Small sample size
 Single centre

Dental Space Maintainers 17

 Table A3: Strengths and Limitations of Controlled Trials and Observational Studies using
Downs and Black5
First Author, Publication Strengths Limitations
Year, Study Design,
Comparators
Nidhi8 2012  Both SM appliances  Did not describe recruitment
applied to each patient so  No indication that
CCT that each patient acted as randomization occurred
own control to address  Statistical analysis may not
GFRCR vs. Band and loop potential confounding be appropriate (used Chi-
(in different quadrants of  Procedure for SM square instead of
mouth) application clearly McNemar’s test); did not
described account for correlation
 No power calculation
 Small sample size
 Single centre
 Both SM appliances  No indication that
9
Subramaniam 2008
applied to each patient so randomization occurred
CCT that each patient acted as  Did not describe recruitment
own control to address  No information on
GFRCR vs. Band and loop potential confounding concealment of allocation
 Defined inclusion/  No power calculation
exclusion criteria  Small sample size
 Defined outcomes  Single centre
Arikan10 2007  Used commonly accepted  Did not describe recruitment
indices for measuring  Did not account for
Observational plaque deposition and confounding
gingival health as  Small sample size; further
Fixed appliance (band and outcomes stratified into smaller groups
loop) vs. removable  Defined most inclusion (verbal vs. written health
appliance criteria education; test vs. control
teeth); made statistical
comparisons even with such
small sample sizes
 Single centre
Comparisons of different types of SM to each other as well as to No SM:
Rubin13 2012  Prospective study  Consecutively recruited
 Defined inclusion/ patients, which may not
Observational exclusion criteria provide a representative
 Defined outcomes sample
Schwarz appliance vs.  Matched comparators  Potential for residual
Lingual holding arch vs. based on age (although confounding
Combination of two methods not described)  Did not describe losses to
appliances vs. Control  Provided power follow-up
calculation  Final time point for outcome
 Statistical analysis measurement and statistical
controlled for some known analysis varied among
confounders (i.e., age) patients (“after treatment

Dental Space Maintainers 18

 Table A3: Strengths and Limitations of Controlled Trials and Observational Studies using
Downs and Black5
First Author, Publication Strengths Limitations
Year, Study Design,
Comparators
 Same investigator with the appliance and
checked reliability of before fixed or orthodontic
measurements made; treatment in the permanent
noted high intraclass dentition” p. 147)
correlation coefficients (≥
0.95)
 Large sample size
 Multi-centre study
Owais 6 2011  Defined inclusion/  No information on
exclusion criteria recruitment
Quasi-RCT  Defined outcomes  Quasi-random method of
 Assessed information treatment assignment
LLHA 0.9 mm wire vs. LLHA bias: same examiner (alternation using odd and
1.25 mm wire vs. No SM reassessed outcome even numbers)
measurements of 10  No information on
randomly chosen patients; concealment of allocation
coefficient of reliability  No power calculation
was > 90%  Small sample size
 Provided numbers lost to  Single centre
follow-up
 Statistical analysis was
appropriate; Bonferroni
correction used for
multiple comparison tests

CCT = controlled clinical trial; GFRCR = glass fiber-reinforced composite resin; LLHA = low er lingual holding arch; RCT =
randomized controlled trial; SM = space maintainer; vs. = versus

Dental Space Maintainers 19

APPENDIX 4: MAIN STUDY FINDINGS AND AUTHOR’S CONCLUSIONS

Table A4: Summary of Findings of Included Studies

First Author, Publication Year, Main Study Findings Author’s Conclusions
Study Design, Comparators
Space maintainer (SM) vs. none:
Alnahwi11 2015 Space loss at 12 months  “Space loss in the groups with SMs and
 > 3 mm space loss for both groups without SMs was similar.” (p. e4)
Observational  At 6 months and 12 months: No  "Space loss after the first year was
difference in space loss between SM generally minimal. Therefore, a clinical
SM (mix of band and loop, lower group and No SM group (No P value decision to provide an SM after a year
lingual holding arch, transpalatal arch, provided) should be considered cautiously. This
and Nance holding appliance) vs. No practice should be limited to cases in
SM Note: No statistical comparisons at 48 which it is crucial to maintain remaining
months space, such as in patients with crowding,
a Class III molar relationship and
premature primary mandibular second
molar loss, or a Class II molar relationship
and premature primary maxillary second
molar loss." (p. e3)

Letti12 2013 Change in IMPA from baseline after eruption  IMPA, 1.NB: “The use of the lingual arch
of permanent canines and premolars prevented the tendency of lingual
Observational  Lingual arch: 1.9° inclination … of lower incisors.” (p. 33)
 No SM: -0.6° Instead, projection was observed, which
Lingual arch appliance vs. No SM  P = 0.083 can be “clinically advantageous” (p. 33)
and “facilitat[e] orthodontic [procedures]
Change in 1.NB from baseline with gain of space…The lower incisors
 Lingual arch: 2.7° were projected after using the lingual arch
 No SM: -0.8° to control the space on the transition from
 P = 0.002 mixed dentition to permanent, however
within acceptable standards.” (p. 33)
Change in 1-NB from baseline  1-NB: "Lingual arch show[ed] efficiency
 Lingual arch: 0.2 mm on the maintenance of the lower arch

Dental Space Maintainers 20

 Table A4: Summary of Findings of Included Studies
First Author, Publication Year, Main Study Findings Author’s Conclusions
Study Design, Comparators
 No SM: 1.6 mm perimeter, that is, preventing the molar
 P = 0.000 movement to mesial and the
linguoversion of the incisors. [This may
lead] to the reduction of mandibular
crowding." (p.32)
Comparisons of different types of SM to each other:
Setia7 2014 Proportion with poor gingival health at 9  "Prefabricated band with custom made
months loop may be a viable alternative to
CCT  Band and loop 36%, conventional band and loop since it has
 Band and custom loop 27%, somewhat more success rate and less
Band and loop vs. Band and custom  Ribbond 40%, plaque deposition." (p. 103)
loop vs. Ribbond vs. Super splint  Super splint 50%  Ribbond and Super splint “observed
 All comparisons: P = 0.949 higher proportions of patients with poor
gingival health as compared to [band and
Caries loop] and [band and custom loop], this
 None developed in the four groups over might be attributed to plaque retentive
9 months of follow-up sites along the fiber framework." (p. 103)
Nidhi8 2012 Caries or gingival inflammation  "None of the failures because of caries or
 At 3 months: None developed in either gingival inflammation were seen in
CCT group in first and third months GFRCR space maintainers. It may be
 At 5 months: None developed in GFRCR because the fibers were coated with
GFRCR vs. Band and loop (in different vs. 6.25% (n = 1 out of 16) in Band and flowable composite and finished
quadrants of mouth) loop adequately to allow maintenance of oral
hygiene." (p. 28)
 "GFRCR space maintainers can be used
as an alternative method to conventional
band and loop space maintainers for
short term space maintenance required
due to premature primary tooth loss." (p.
29)

Dental Space Maintainers 21

 Table A4: Summary of Findings of Included Studies
First Author, Publication Year, Main Study Findings Author’s Conclusions
Study Design, Comparators
Subramaniam 9 2008 Caries or gingival inflammation  “The GFRCR space maintainer seems to
 None in either group over 12 months of be a suitable alternative to the
CCT follow-up conventional fixed space maintainer." (p.
S103)
GFRCR vs. Band and loop
Arikan10 2007 Plaque index score  "Both fixed and removable SM cause an
 At baseline, 6 months and 9 months: no increase in plaque accumulation…Special
Observational difference between groups (P > 0.05) concern should be given on oral and
 At 3 months: groups differed (P <0.05) dental health of children who use fixed
Fixed appliance (band and loop) vs. SM since they were found to cause an
removable appliance Bleeding index score increase in bleeding index and pocket
 At baseline: no difference between depth compared to the removable
groups (P < 0.05) appliances." (p. 233)
 At 3 months, 6 months and 9 months:
groups differed (P < 0.05)

Difference in pocket depth scores since

baseline
 At 3 months, 6 months and 9 months:
groups differed (P <0.05)

Comparisons of different types of SM to each other as well as to No SM:

Rubin13 2012 Proportion of patients with eruption difficulty  "All treatment groups had a higher
 Schwarz appliance: 7.8% percentage of mandibular second molar
Observational  Lingual holding arch: 4.7 % eruption difficulty when compared with the
 Combination: 14.7% control group." (p. 150)
Schwarz appliance vs. Lingual holding  Control: 1%  “Schwartz appliance or the combined
arch vs. Combination of two Schwarz and lingual holding arch in the
appliances vs. Control Logistic regression (odds ratios NR) mixed dentition was associated
 Schwarz vs. control: P = 0.04 significantly with mandibular second
 Lingual holding arch vs. control: P = 0.42 molar eruption difficulty.” (p. 151)

Dental Space Maintainers 22

 Table A4: Summary of Findings of Included Studies
First Author, Publication Year, Main Study Findings Author’s Conclusions
Study Design, Comparators
 Combination vs. control: P = 0.018
 Any appliance vs. control: P = 0.026

Owais 6 2011 Change in lower incisor inclination to the  “Lower incisor inclination to the
mandibular plane (Li-Mand) at end of mandibular plane was increased in [LLHA
Quasi-RCT treatment since baseline 0.9 mm wire] and [LLHA 1.25 mm wire]…
 LLHA 0.9 mm wire: 4.50° ± SE 0.77 Significant differences were found
LLHA 0.9 mm wire vs. LLHA 1.25 mm  LLHA 1.25 mm wire: 3.36° ± SE 1.07 when…compared with the controls.” (p.
wire vs. No SM  No SM: -0.24° ± SE 0.82 40)
 Difference between LLHA 0.9 mm wire  “The LLHA used in both treatment groups
vs. No SM: 4.74° (P ≤ 0.01) tended to cause proclination of Li-Mand
 Difference between LLHA 1.25 mm wire and forward movement of the lower
vs. No SM: 3.60° (P ≤ 0.05) incisors relative to the A-Pog line (Li-A-
 Difference between LLHA 0.9 mm wire Pog).” (p. 41)
vs. LLHA 1.25 mm wire: 1.14° (p> 0.05)  “The LLHA used in both treatment groups
preserved arch length throughout the
Change in distance of the lower incisor edge study duration. There was arch length
to the A-Pogonion (Li-A-Pog); Lower molar gain of 0.53 mm in [LLHA 0.9 mm wire]
angulation to mandibular plane (LM1-Mand); and arch length loss of 0.98 mm in [LLHA
Arch length; Arch depth; Intercanine width; 1.25 mm wire].” (p. 41)
Intermolar width; Primary second premolar
extraction space
 No statistically significant difference
between groups (Table 3, p.40)
1.NB = angle betw een long axis of low er incisor and line NB; 1-NB = linear distance mm betw een most prominent portion of the low er incisor crown and line NB; CCT = controlled
clinical trial; GFRCR = glass fiber-reinforced composite resin; IMPA = angle betw een long axis of low er incisor and base of mandible; NR = not reported; RCT = randomized controlled
trial; SE = standard error; SM = space maintainer; vs. = versus

Dental Space Maintainers 23

APPENDIX 5: ADDITIONAL REFERENCES OF POTENTIAL INTEREST

Cost-effectiveness analysis (not specific to pediatrics):

Antonarakis GS, Prevezanos P, Gavric J, Christou P. Agenesis of maxillary lateral incisor and
tooth replacement: cost-effectiveness of different treatment alternatives. Int J Prosthodont. 2014
May-Jun;27(3):257-63.

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