Clinical and Radiographic Outcomes of Vital

In amed Pulp Therapy in Immature Permanent

Teeth with Irreversible Pulpitis: A Retrospective
Case Series
Wen Xiao 
Shanghai Jiao Tong University School of Medicine
Wentao Shi 
Shanghai Jiao Tong University School of Medicine
Jun Wang  (  [email protected] )
Shanghai Ninth People’s Hospital, College of Stomatology, Shanghai Jiao Tong University School of
Medicine

Research article

Keywords: Retrospective study, immature teeth, vital pulp therapy, apical periodontitis, radiographic
outcomes

DOI: https://doi.org/10.21203/rs.3.rs-52921/v1

License:   This work is licensed under a Creative Commons Attribution 4.0 International License.  
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Abstract
Background

To assess the resolution of clinical symptoms and radiographic changes in root length and apical
diameter in immature permanent teeth with irreversible pulpitis or apical periodontitis with vital in amed
pulp therapy (VIPT).

Methods

  The faculty members at the Ninth People’s Hospital pediatric dentistry department were invited to submit
consecutive VIPT cases treated by them, irrespective of outcome, between 2014 and 2016. Clinical
success rate, radiographic changes in periapical radiolucency, and apical closure were analyzed, and
radiographic changes in the apical diameter and root length were quanti ed.

Results

   Thirteen of 14 submitted cases of irreversible pulpitis in immature teeth met the inclusion criteria. The
follow-up period ranged from 17 to 37 (average, 26.5 ± 7) months. All 13 treated teeth (100%) survived
and 12 (92.3%) met the clinical criteria for success throughout the follow-up period, with 92.3% of cases
(12 of 13) showing a signi cant periapical radiolucency decrease and 84.6% (11 of 13) showing
complete apical closure at the last visit. The change in apical diameter and root length were obvious.

Conclusions

Vital in amed pulp therapy approaches might be of particular value in restoring root development and
apical closure and can be an option in treating immature teeth with irreversible pulpitis, even apical
periodontitis.

1 Background
A vital pulp is a prerequisite for immature permanent tooth development. However, trauma, caries,
developmental malformations, and other factors often lead to pulpal lesions of immature permanent
teeth.

It used to be generally accepted that a history of spontaneous or lingering provoked pain, swelling, or
periapical radiolucency was indicative of extensive, irreversible in ammatory changes of the pulp tissue.
These changes meant that the pulpal in ammation had reached a level at which its elimination was not
possible without removal of the entire pulp. Thus, radical treatment such as apexi cation, apical barrier
surgery, or regenerative endodontic treatment (RET) should be performed for immature teeth [1]. Although
an apical barrier can be established by apexi cation and apical barrier surgery, they do not help restore a
functional pulp-dentin complex and do not allow further root development, leaving the tooth susceptible
to fracture [2–5]. In recent studies, RET provided a new treatment modality for the previously described

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cases. There have been many successful case reports and clinical trials published [6–9]. However, the
treatment is complicated [10], and its outcome unpredictable [11].

It has been found that clinical diagnosis based on pain quality, history, and swelling or periapical
radiolucency has a low correlation with pulp status in situ [12]. Therefore, it is doubtful that radical
treatment should be performed for teeth only by clinical diagnosis [13]. Moreover, it is reported that before
the infection involved the entire dental pulp, there were in ammatory changes around the apical area [14].
But there were still residual nerve bers in the pulp even if the pulp infection was serious or partially
necrotic [14], and there were still residual vital pulp tissues in the pulp cavity even in immature permanent
teeth with periapical periodontitis and bone destruction [15]. The surviving cells had the potential to
resume proliferation and differentiation after eliminating the in ammation and restoring pulp function
[15]. Additionally, compared with the mature teeth, the pulp tissue of immature permanent teeth has a rich
blood supply and high cell composition [12]. All these events make it seem reasonable to conserve the
residual vital pulp tissue and eliminate the infection to induce root development, indeed, this has been
veri ed by many case reports.

Ronald et al.[16, 17] reported that during root canal exploration, the following conditions appear,
indicating that there is residual vital pulp tissue in the root canals of immature permanent teeth with
irreversible pulpitis, even with apical periodontitis: (1) in cases when inserting a le or gutta-percha cone
into the canal, a little resistance, caused by the presence of tissue, is felt; (2) the patient reports a
sensation of pain; (3) the patient still feels uncomfortable even under local anesthesia. Treatment to
conserve residual vital pulp tissues was consistent with the hypothesis of a functional restoration of
biologic root development, so it was de ned as Vital in amed pulp therapy (VIPT) [17]. In previous case
reports, the researchers [17–21] all achieved good prognosis of clinical symptom regression, apical
closure, and even continued root development.

Case series suggest that Vital in amed pulp therapy approaches might be of particular value in restoring
root development and apical closure in some di cult cases but lack quantifying analysis. The purpose of
this retrospective study is to evaluate the clinical and radiographic changes and quantify those
radiographic changes in patients receiving VIPT for immature permanent teeth with irreversible pulpitis,
even with apical periodontitis.

2 Materials And Methods

Sample Selection
This study received approval from the O ce of Human Research Ethics at the Ninth People’s Hospital,
Shanghai Jiao Tong University, School of Medicine (Ref: SH9H-2019-T350-1). Our research has been
conducted in full accordance with the World Medical Association Declaration of Helsinki.

The Ninth People’s Hospital Department of Paediatric Dentistry has a prescribed methodology for VIPT,
and every faculty member has been trained in standard operating procedure. The faculty were invited to
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submit consecutive VIPT cases treated by them, irrespective of outcome, during the period June 2014 to
June 2016. The faculty members were asked to ll out the clinical records data with radiographic and
other examination notes for submission; patient’s personal information was masked.

Each case that ful lled the following criteria was included in the outcome analysis: (1) children in good
general health with no systemic diseases and aged 7-12 at the time of treatment; (2) immature
permanent teeth (stage 7-9 according to Nolla's criteria[22]) diagnosed as irreversible pulpitis with or
without periapical pathology at the initial appointment; (3) the immature teeth were treated with VIPT and
the nal restoration placed; (4) patients were followed up for at least 12 months and their records were
complete.

Data Extraction
Cases identi ed that met the inclusion criteria were assigned a research subject number, and data were
extracted from their clinical record, and calibration exercises were blinded to the research purpose. Data
collection was accomplished using a standardized electronic form, including history (patient’s sex, age,
tooth number, Nolla's stage), etiology, preoperative signs and symptoms, presence or absence of
periapical radiolucency (PARL), treatment, and follow-up periods. Details of the clinical procedure and any
variation were also recorded, and the preoperative radiographs were checked for immature apices.

The nal data set was exported to Excel and saved on a secure server for analysis. All radiographs related
to study cases were collected and stored in a digital format on a secure server.

Clinical Protocol
The operators completed all the study procedures at the Department of Paediatric Dentistry, Ninth
People’s Hospital, Shanghai Jiao Tong University, School of Medicine, China. The treatment was
completed in two or three visits. At the rst appointment, parallel periapical x-ray lms were taken before
the operation to examine the periapical tissue and root development. The protocol consisted of local
anesthesia (lidocaine 2% without adrenaline), rubber dam isolation, gaining access to the pulp chamber,
exploring the vital pulp tissue in the root canal with 25# K- le and recording the tissue’s depth, and
irrigating with copious amounts of 2.5% NaOCl, 3% hydrogen peroxide solution, and 0.9% sterile saline
solution (NS) without instrumentation (NS as last irrigation). After irrigating, the root canal was dried with
sterile paper points, calcium hydroxide paste (Ninth People's Hospital, Shanghai, China) was placed in the
root canal, and the cavity was sealed with glass ionomer cement (GlasIonomer FX-II; Shofu Inc, Kyoto,
Japan). Two weeks later, if clinical symptoms persisted, the initial treatment procedures were repeated.
Otherwise, the tooth was isolated with a rubber dam for the next treatment. After local anesthesia and
removal of the temporary restoration, the canal was irrigated with copious amounts of 2.5% NaOCl and
3% hydrogen peroxide solution and 0.9% NS (NS as last irrigation) and dried with sterile points. Calcium
hydroxide paste or MTA (Pro-Root MTA White; Densply International, Inc, Konstanz, Germany) or i-Root BP

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Plus (Innovative BioCeramix Inc, Burnaby, Canada) was placed over the residual vital pulp tissue and
covered by conventional glass ionomer cement and resin composite (Z350; 3M ESPE, St Paul, Minn.,
USA) were used to ll the access cavity. The patient was followed up at 3, 6, and 12 months, then at
regular 6-month intervals after completion of VIPT. Follow-up included clinical assessment of pain or
discomfort, swelling, sinus tract, mobility, and acquisition of a periapical radiograph.

Clinical Outcomes
Tooth survival and clinical success were evaluated as clinical outcomes [23]. Tooth survival was de ned
as the tooth’s remaining in the arch throughout the study period. While clinical success was de ned as a
tooth that survived and without any clinical assessment during the recall period [24].

Radiographic Outcomes and Analysis

Study investigators who were blinded to the research purpose evaluated the preoperative and
postoperative radiographs. The records included the presence or absence of PARL and root development
changes (the changes in apical foramen width and root length). The changes in apical foramen width
and root length were measured from the preoperative and postoperative images. The periapical X-ray
lms should be taken by the paralleling technique and standardization performed by using TurboReg
(Biomedical Imaging Group, Swiss Federal Institute of Technology, Switzerland) [24], better than CBCT
(cone-beam computed tomography) for the consideration of human ethics. For root length, the
measurements were done on a straight line from the CEJ to the midpoint of the radiographic apex from
both mesial and distal, while the apical diameter was measured as a straight line across the radiographic
apical foramen. Then the results were measured by using NIH Image J (version 1.41; National Institutes
of Health, USA). We present the data as percentage change from preoperative values rather than the
actual millimetric data to eliminate one potential source of systematic error in the overall analysis of
treatment outcome [25]. The same investigator collected all the measurements and repeated after 2
weeks, and the mean of the two replicates was reported as the nal value.

Statistical Analysis
The Fisher test was used to compare the proportion of cases with or without PARL present and closure of
the apical foramen at the 3-, 6-, and 12-month follow-ups and the last recall time versus the baseline
proportion of cases. While the changes in root length and apical diameter were expressed as mean ±
standard error of mean. The data were summarized and analyzed by professional statistician using
SPSS 13.0 statistical software (SPSS Inc, Chicago, USA) and P < 0.05 was regarded as statistically
signi cant. Graphs were generated by using GraphPad Prism 8 (GraphPad Software Inc, Calif, USA).

3 Results
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Baseline Characteristics of the Study Population
Fourteen cases were treated and submitted by the faculty during the previously stated treatment duration.
A total of 13 immature teeth out of 14 (in 13 patients) between the ages of 7 and 12 years met the
inclusion criteria. One case was excluded because of lack of a detailed description of the treatment
protocol.

Of the 13 cases (including three incisors, ve premolars, and ve molars), etiology of the teeth included
traumatic (one tooth), anatomic (seven teeth), and carious ( ve teeth). All treated teeth had preoperative
clinical symptoms with necrotic dental pulps, 84.6% (11 of 13) of which had periapical symptoms (11/13
subjects reported sensitivity to percussion, while 9/13 had a sinus tract) and radiographic periapical
pathology. The demographics and baseline clinical data of the patients are collected in Table 1.

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 Table 1
Patient Demographics and Baseline Characteristics
     Vital in amed pulp therapy (N=13)

  Variable    Teeth(N)      %

Sex    

  Female       7    53.85

  Male       6    46.15

Age-years     9.9±1.5

Follow up Period-Months     26.5±7

Tooth type    

  Incisor       3    23.08

  Premolar       5    38.46

  Molar       5    38.46

Etiology    

  Trauma       1     7.69

  Anatomical       7    53.85

  Caries       5    38.46

Stage of Root Development (Nolla)  

    7       4    30.77

    8       3    23.08

    9       6    46.15

Signs and symptoms    

   Absent       0     0.00

   Present       13    100.00

Apical periodontitis    

   Absent       2    15.38

   Present       11    84.62

Continuous and ordinal variables are presented as mean ± standard deviation. Frequency of all
categorical variables is presented as number (N) and percentage (%).

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Clinical Outcomes
The cases were followed from 17 to 37 (average, 26.5 ± 7) months, with a review at 3, 6, and 12 months,
then once every 6 months. All 13 teeth survived, and 92.3% (12 of 13) met the study criteria for clinical
success at 12 months. Representative cases are presented in Figures 1-3.

Radiographic Outcomes
92.3% of cases (12 of 13) showed no periapical radiolucency (PARL) at the 12-month follow-up and
84.6% of cases (11 of 13) exhibited complete radiographic apical closure at the last post-treatment visit
(Figure 4). The changes in apical diameter and root length were obvious. In apical diameter averaged
decreasing 7.98% at 3 months, 70.3% at 12 months, and 91.0% at the last review, while in root length
averaged increasing 11.4% at 3 months, 27.4% at 12 months and 33.36% at the last review (Figure 5). At
the last review, 12 patients had achieved clinically meaningful change for apical diameter measurements,
and ve had met this criterion for root length measurements [23].

4 Discussion
Although several case presentations have reported the clinical and/or radiographic outcomes of VIPT [17-
21], to our knowledge, this is the rst retrospective study to observe the quanti cation of clinical and
radiographic changes. This study included all the tooth types and Nolla’s 7-9 stage of root development.
The etiology of the teeth in this study included traumatic, anatomic, and carious (including all the
etiologies for immature permanent teeth with irreversible pulp infection or periapical infection), so the
result of clinical and radiographic changes of VIPT is persuasive. The results will be compared with the
contemporary treatment in immature permanent teeth with irreversible pulp infection or periapical
infection, RET and apexi cation. In addition, in this study, all dentists were trained in standard operating
procedure to control the case-to-case variability.

In this study, we analyzed the outcome of clinical symptoms and radiographic healing of irreversible
pulpitis and apical periodontitis. Then the radiographic signs of further root development were
quantitated, including apical diameter and root length. All the teeth survived; 92.3% of our cases (12 of
13) showed resolution of periapical lesions and 84.6% of cases (11 of 13) showed complete apical
closure at the last post-treatment visit. Our ndings concerning survival and clinical success are in
agreement with those of who reported the survival and clinical success of RET [6, 25-26] and closely
followed by the investigations of those who reported the survival and clinical success of apexi cation
[27-28]. It can be concluded that VIPT can effectively alleviate the clinical symptoms as RET and
apexi cation, and resolution of radiographic pathology.

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Apexi cation, although it confers high degrees of clinical success, the root cannot develop
physiologically [2-4], while RET was reported as a new treatment was able to realize root development.
Lin, et al. [9] reported on the effectiveness of RET compared with apexi cation in root development
(73.9% vs 26.5%). Decreasing apical diameter was found in our study: 92.3% of the treated teeth (12 of
13) showed at least a 20% decrease in apical diameter, and complete apical closure occurred in 84.6% of
the treated teeth (11 of 13) at the last visit. The average decrease in apical diameter in individual cases
from the preoperative radiograph to follow-up at 3, 6, and 12 months and last recall was respectively
7.98%, 24.1%, 70.3%, and 91.0%. In RET research, Li et al. [29] observed a change in apical diameter at 3,
6 and 12 months was respectively 20.40%, 51.16% and 72.90%. In the aspect of continued root
lengthening, 38.5% of cases (5 of 13) met clinically meaningful within-case change [23] at 12 months.
There was a 27.4% increase in root length at 12 months across all the cases in our study, compared with
several clinical case series and retrospective studies in RET, which had reported radiographic changes in
root length and reported the change of 4%-23.37% [6, 24, 25, 27, 29]. It can be concluded that VIPT can
effectively achieve the goal of root develop physiologically, and the results close to performance of RET,
superior to apexi cation techniques.

The only case in this study that failed in resolving periapical lesions was one of dens evaginatus, having
too severe apical periodontitis. Several researchers reported that Hertwig’s epithelial root sheath and/or
the apical papilla contributed to the recovery of the apical periodontitis and continued tooth development
[24, 27]. Therefore, too large a periapical radiolucency or root tip cyst should be cause for exclusion for
VIPT. A case with an outstanding outcome in continuing tooth development was an 8-year-old boy with
dens evaginatus in #35 (Nolla 7) teeth who came to the clinic immediately (after fracture of the central
cusp) having painful symptoms. The incident threw light on a histological feature of the pulp tissue of
immature permanent teeth having the characteristics of a rich blood supply and high cell composition,
which makes its regeneration and reparability much more feasible [12].

In conclusion, this study provides independent con rmation of the ndings of VIPT by analyzing
immature permanent teeth with irreversible pulp infection or periapical infection. The patients treated with
VIPT became asymptomatic, no sinus tracts were evident, and the apical periodontitis was resolved.
Moreover, there was radiographic evidence of root continuing development (apical closure and increased
root length). Radiographic ndings and clinical outcomes in immature teeth suggest that root canal
exploration should be carried out when pulpitis in immature permanent teeth spreads to all pulps, even
with periapical signs or symptoms. These residual vital tissues should be preserved as much as possible
to regenerate a functional pulp-dentin complex. VIPT approaches can be an alternative option to treat
immature teeth with irreversible pulpitis, even apical periodontitis.

There are several limitations to the present study. First, it is a retrospective case series evaluation, hence
presents a lower level of evidence compared with a prospective randomized controlled trial. Nevertheless,
this is the rst retrospective study to observe the quanti cation of clinical and radiographic changes of
the VIPT techniques. Second, the simple size was too small. In the published retrospective studies or case
series, Sarah et al. [30] presented only 6 typical cases having different outcomes, whereas others case
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series presented 1 to 8 typical cases [17-21]. But all the pioneering efforts brought some suggestions for
the clinical work and our ndings shed light on the possibility of improving the clinical signs and
symptoms and radiographic evidence of root development in VIPT. Therefore, prospective randomized
clinical trials are needed to provide strong quantitative evidence for both treatment e cacy and the
potential for adverse effects.

Abbreviations
Apx Apexi cation

VIPT Vital in amed pulp therapy

RET Regenerative endodontic treatment

MTA Mineral trioxide aggregate

PARL Periapical radiolucency

Declarations
Ethical approval and consent to participate:
This study received approval from the O ce of Human Research Ethics at the Ninth People’s Hospital,
Shanghai Jiao Tong University, School of Medicine (Ref: SH9H-2019-T350-1). All procedures performed in
studies involving human participants were in accordance with the ethical standards of the institutional
research committee and with the 1964 Helsinki declaration and its later amendments or comparable
ethical standards. Informed consent was obtained from all individual participants included in the study,
and the written informed consent was obtained from a parent or guardian for participants under 16 years
old.

Consent for publication and Competing Interests:

Wen Xiao declares that she has no con ict of interest. Wentao Shi declares that he has no con ict of
interest. Jun Wang declares that she has no con ict of interest.

Funding:
This work was supported by the National Key R&D Program of China (2017YFC0840100,
2017YFC0840110) (Prof. Jun Wang); the Interdisciplinary Program of Shanghai Jiao
Tong University(YG2017QN04) (Dr. Wen Xiao) and Seeding Foundation of Shanghai Research Institute of
Stomatology (2016-08) (Dr. Wen Xiao).

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Authors' contributions:
JW conceived the ideas; WX collected the data; WS analyzed the data; WX led the writing.

Acknowledgements:
The authors deny any con icts of interest related to this study.

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Figures

Figure 1

Complete healing category. Mandibular left rst molor (#36). Incresed thickening of the canal walls and
continued root maturation after vital in amed pulp therapy (VIPT). (A) Preperative radiograph. (B) Follow-
up radiograph at 6 months. (C) Follow-up radiograph at 3 years

Figure 2

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Maxillary right lateral incisor (#12) (A) Preperative radiograph of tooth with open apex and periapical
radioluccency (B) Follow-up radiograph at 3 months (C) Follow-up radiograph at 18 months. Note
continuous root extension and canaal wall thickening, relative to the preperative image.

Figure 3

Mandibular left second premolar (#35) (A) Preperative radiographic image showing an incompletely
developed apex and a periapical radiolucency. Note the sinus tract that traces to the apex of this tooth.
(B) Follow-up radiograph at 3 months. (C) The radiograph demonstrating complete resolution of the
radiolucency and continued development of the apex (calci cation in root canal) at 18 months follow-up
(D) Folow-up radiograph at 26 months

Figure 4

Radiographic ndings regarding proportion of subjects with PARL and open apices at varios time points
in the study. (A) Proportion of teeth with PARl signi cantly decresed by 6 months folow-up visit. (B)
Proportion of subjects with open apex began to decrese and became signi cantly different from baseline
at 12 months. ***P<0.05 versus baseline BL-Baseline, LT- Last time recall

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Figure 5

Scatter plot demonstrating the percentage change in neasured radiographic (A) apical diameter and (B)
root length. Error bars represent meant standard error of the mean. Horizontal line denotes a 20% change,
representing a clinically meaningful change. LT-LAst tome recall

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