Clinical and Radiographic Evaluation of Pulpotomy Technique for Preserving Vitality of Traumatized Anterior Permanent Immature Teeth: A Randomized Clinical Trial
Phase: PHASE2
Conditions: Pulp Exposure, Dental
Sponsor: Gihan M Abuelniel ,PhD

 
 
 
 
 
Clinical and Radiographic Evaluation of Pulpotomy Technique for Preserving 
Vitality of Traumatized Anterior Permanent Immature Teeth: A Randomized 
Clinical Trial 
 
 
 
 
 
 
Protocol submitted to the Faculty of Dentistry, Cairo University  
by 
Dr. Gihan Abuelniel 
Associate Professor of Pediatric Dentistry 
 
Faculty of Dentistry 
Cairo University 
January 18 , 2017  
 
 
 
 
 
 
 
 
 
 
 

 
 
I. Administrative information:     
1. Title: 
   
Clinical and Radiographic Evaluation of Pulpotomy Technique for 
Preserving Vitality of Traumatized Anterior Permanent Immature 
Teeth: A Randomized Clinical Trial 
2. Protocol Registration: 
To be registered on Clinicaltrial.gov   
3. Protocol version: 
Final version.    
4. Funding:    
This trial is self-funded.    
  
5.  Roles and responsibilities:   
1. Dr. Gihan Abuelniel (Abuelniel G.M) Associate Professor of Pediatric 
Dentistry, Cairo University. Responsible for the clinical part of study, and 
Data monitoring.  
2. Professor Monty Duggal (Duggal M.S) Professor of Pediatric Dentistry, 
National University of Singapore, responsible for the writing revision and 
proof reading. 
3. Dr. Nihal Kabel (Kabel N.R) Associate Professor of Pediatric Dentistry,
 
Misr University for sciences and technology. Responsible for the clinical 
evaluation of the cases at the evaluation intervals 
 
II. Introduction   
6-background and rationale: 
Description of research question: 
P: children with vital traumatized exposed immature maxillary 
permanent incisors 
I: Pulpotomy using Biodentine 
C: MTA pulpotomy 
O: 
 

 
 
 
Outcome 
Tool/Device 
Unit 
Primary 
Outcome 
spontaneous pain, 
sensitivity to percussion⁄ 
palpation) 
 
Pain questionnaire 
Binary 
Swelling or sinus tract 
Visual examination 
by the third author 
Binary 
Mobility 
Back of the mirror 
Binary 
Secondary 
outcome 
Stage of root development 
Standardized 
periapical 
4 stages 
Presence of 
radiolucency 
Standardized 
periapical 
Binary 
 
 
 
S: Randomized clinical trial 
T: 18 months (Baseline,6, 12 and 18 months) 
 
Research question: is Biodentine used as pulpotomy material in vital 
traumatized exposed immature maxillary permanent central incisors more 
successful clinically and radiographically than MTA pulpotomy? 
 
Justification for undertaking the trial: 
 
The occurrence of dental trauma in permanent teeth is a common event 
worldwide [1]. Children and adolescents are most frequently affected, and two-
thirds of all dental trauma are found among these populations [1,2]. with the 
anterior permanent teeth being the most affected [1, 4-6].  
       Traumatic injuries affecting teeth may result in pulpal and periapical disease. 
Complicated crown fractures which involve the enamel, dentin and pulp occur in 
0.9 - 13% of all dental injuries [2,3]. Vital pulp therapy (VPT) is the treatment of 
choice for traumatized immature teeth with pulp exposure [5,6]. VPT aims for 
continuation of root development, which leads to apical closure and strengthening 
of the root structure [7]. If the pulp vitality of a traumatized immature tooth is lost, 

 
 
endodontic treatment will constitute a real challenge. It is difficult to obtain an 
appropriate apical seal in these teeth by using the conventional obturation 
methods. Furthermore, thin root canal walls make the teeth susceptible to future 
fractures [8]. 
     Primary objective of pulp therapy is to maintain the integrity and health of the 
teeth and their supporting tissues and to preserve vitality of the tooth pulp, 
especially in young permanent teeth with immature roots, where the pulp is 
integral to continue apexogenesis. Long term retention of a permanent tooth 
requires a root with a favorable crown/ root ratio and dentinal walls that are thick 
enough to withstand normal function. therefore, pulp preservation is a primary 
goal for treatment of the young permanent dentition. 
[9] 
         In modern dentistry, vital pulp therapy (VPT), whenever feasible, should be 
considered as an effective reasonable alternative to endodontic treatment [10]. In 
clinical practice, VPT includes stepwise excavation, pulp capping (direct and 
indirect) and pulpotomy (miniature, partial and complete), based on the amount 
of preserved coronal pulp [11]. The main goal of these conservative methods is to 
maintain the normal pulp or remove contaminated pulpal tissue in order to 
promote the repair process [9-11]. Therefore, immature teeth eventually gain 
additional benefit from VPT, considering their weak structural nature [11]. 
 
        Vital pulp therapy has been increasingly considered as a minimally invasive 
approach for the management of teeth with inflamed pulps compared to the 
conventional approach of root canal treatment [12,13]. Among the factors that 
contributed to this choice are (1) the high frequency of technically inadequate 
root fillings and associated apical periodontitis despite new technologies in root 
canal preparation and filling , (2) the numerous advantages of VPT in terms of 
preserving tooth structure ,maintaining possible proprioceptive defensive 
mechanisms of the remaining pulp, and reducing the propensity of tooth fracture, 
(3) comparable success rates of VPT compared to RCT over five years of follow‐
up [6,7] . 
 
       Traditionally Ca (OH)2 has been used for VPT for many years [14]. Recently 
MTA has replaced Ca (OH)2 due to its ability to form an apatite-like layer, its 

 
 
biocompatibility and its lack of cytotoxicity [15]. MTA due to its, biocompatibility 
and its ability to form cementum attachment has not only been used as a root-end 
filling material but also has been used as in pulpotomy, apexification, direct pulp 
capping and as a perforation repair material but has some drawbacks like handling 
property, high cost, long setting time and discoloration [14].  
      A magical capsule to overcome the limitations of MTA raised in the dental 
field called (Biodentine) [15]. It is considered a calcium silicate cement that was 
introduced as a ‘dentine replacement’ material, comparable to MTA in terms of 
biocompatibility and induction of a calcific barrier [16]. It possessed additional 
improvement of several properties such as mixing, handling, shorter initial setting 
time (12 min, with reports from 6.5–45 min) and less coronal discoloration [13]. 
 
       Limited clinical data were available on the use of Biodentine in VPT; 
recently only three clinical trials compared Biodentine to MTA as pulp capping 
materials for cariously exposed teeth with high success rate approaching 100% at 
1‐year follow‐up in young patients. [16] In a case report, Biodentine was 
successful in pulpotomy of traumatized permanent incisors at 48 months of 
follow‐up [17,18].  
       Radiographic imaging of the dentoalveolar complex has been assessed   using 
conventional periapical radiography, the benchmark for intraoral radiographic 
imaging for decades. Their known limitations of image magnification, distortion, 
superimposition and overlap of anatomy always led to unclear and 
misrepresentation of structures. Although the advent of digital intraoral 
radiography didn’t improve these limitations, it provided a more active image 
manipulation than the film-based radiographs and reduced patient exposure 
substantially. [19, 20]    
 
7 - Objectives and hypothesis: 
 
The objective of this prospective randomized clinical trial is to compare the 
clinical and radiographic outcomes of MTA and Biodentine as vital pulp therapy 
materials (pulpotomy) preserving the vitality of traumatized immature anterior 
permanent teeth. 

 
 
8-Trial Design: 
 
Randomized clinical trial (RCT), parallel groups with 1:1 allocation ratio, Triple 
blinded (patient, clinical and radiographic assessor of the results and statistician) 
 
 III- Methods: 
9-Study settings: 
This study will be carried out on patients attending the outpatient clinic in 
Pediatric Dentistry department, Faculty of Dentistry, Cairo University, Egypt. the 
procedures will be carried out by Dr. Gihan Abuelniel Associate Professor of 
Pediatric Dentistry in Pediatric Dentistry clinic. expected time duration from 
2017 to 2018.  
 
10- Eligibility criteria: 
Inclusion criteria 
• The patient age range 7.5-9 years. 
• Noncontributory medical history 
• Unilateral/ and or bilateral central incisors tooth with complicated trauma 
(exposure size ≥ 1mm)  
• The tooth should give positive response to cold testing 
• Clinical diagnosis of reversible pulpitis without periapical rarefaction 
• The tooth is restorable, mobility was within normal limits 
• No signs of pulpal necrosis including sinus tract or swelling 
Exclusion criteria 
• Teeth with mature roots 
• Signs and symptoms of irreversible pulpitis  
• Non-restorable teeth 
• Negative response to cold testing, the presence of sinus tract or swelling 
• No pulp exposure  
• Bleeding could not be controlled after full pulpotomy in 6 minutes 
IV- Intervention: 
Diagnosis: 
1. Full history data will be collected, including personal, medical and 
previous dental data  
2. Clinical examination using mirror and probe to assess the inclusion criteria. 
3. Radiographic examination using preoperative digital periapical radiograph 
to assess the inclusion criteria. 

 
 
4. Preoperative photograph will be taken. 
Operative procedure: 
Experimental group: 
1. Injection of local anesthesia and rubber dam isolation. 
2. Roof of the pulp chamber will be removed by a fissure diamond bur 
(Diatech, Heerbrug, Switzerland) and high-speed handpiece with coolant.  
3. The pulps will be amputated to the orifice level using a long-shank 
diamond round bur.  
4. Haemostasis will be achieved by gentle placement of a saline-moistened 
cotton pellet over amputated pulps for 5–10 min. 
5. Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des 
Fausse´s, France) will be mixed according to the manufacturer’s 
instructions, radicular pulp will be covered by the material using a wet 
cotton pellet. 
6.  A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be 
placed over the pulpotomy agent before final restoration of composite resin 
(ClearﬁlTM, Kuraray, New York, USA) will be done. 
7.  Immediate post-operative radiograph and photograph will be taken. 
Control group: 
The same procedures will be carried out as the experimental group, but the 
pulp stumps will be covered with white mineral trioxide aggregate (MTA) 
ProRoot® MTA (Dentsply/ Johnson City, TN, USA) will be used as the 
reference material for comparison and will be prepared according to the 
manufacturer’s instructions. A 3-mm-thick layer of MTA will be placed over 
the amputated pulps and will be gently adapted to the dentinal walls using a 
wet cotton pellet deep onto the radicular pulp. A self-cure glass ionomer (GC; 
GC Corporation, Tokyo, Japan) will be placed over the pulpotomy agent 
before final restoration of composite resin (ClearﬁlTM, Kuraray, New York, 
USA) will be done.  
 
 
Postoperative care: 
Instructions to avoid lip biting in addition to oral hygiene measures. 
 
Follow up: 
Assess the outcomes clinically and radiographically at (baseline, 6, 12 and 18 
months). 
 
 
 

 
 
Criteria for discontinuing or modifying intervention: 
In case of an unsuccessful outcome after pulpotomy, the teeth will be managed 
by other pulp therapy techniques. 
 
Strategies to improve adherence to intervention: 
Explanation to the parents about the importance of follow up visits in addition 
to treatment of other dental problems. 
 
Concomitant care: 
None needed. 
12- Outcomes: 
 
Outcome 
Tool/Device 
Unit 
Primary 
Outcome 
spontaneous pain, 
sensitivity to percussion⁄ 
palpation) 
 
Pain questionnaire 
Binary 
Swelling or sinus tract 
Visual examination 
by the third author 
Binary 
Mobility 
Back of the mirror 
Binary 
Secondary 
outcome 
Stage of root development 
Standardized 
periapical 
4 stages 
Presence of 
radiolucency 
Standardized 
periapical 
Binary 
 
 Primary outcome: 
Clinical assessment of the findings in the table will be conducted at follow up 
intervals (baseline, 6, 12 and 18 months) 
  
Secondary outcome: 
Radiographic assessment of stage of root development, and presence of 
radiolucency will be conducted through digital periapical radiographs by parallel 
technique using film holders. The assessments will be carried out at follow up 
intervals (baseline, 6, 12 and 18 months) 
 
 
 
 

 
 
13- Participants timeline: 
 
 
Study period 
 
Enrolment  Allocation  
Post allocation 
Close out 
Time point 
For 9 
months 
0 
6 months 
12 months 
18 months 
Enrolment:  
 
 
 
 
 
Eligibility screen 
√ 
 
 
 
 
Informed consent 
√ 
 
 
 
 
History taking 
√ 
 
 
 
 
Clinical examination √ 
 
 
 
 
Preoperative 
radiograph 
√ 
 
 
 
 
Allocation  
 
√ 
 
 
 
Interventions: 
 
 
 
 
 
Access preparation 
 
√ 
 
 
 
Placement of 
Biodentine 
(experimental group) 
 
√ 
 
 
 
Placement of MTA 
(Control group) 
 
√ 
 
 
 
Final restoration 
 
√ 
 
 
 
Assessment  
 
 
 
 
 
Periapical radiograph 
as baseline reference 
 
 
√ 
√ 
√ 
Clinical examination 
to assess pain, 
swelling, fistula, 
tooth mobility 
 
 
√ 
√ 
√ 
Periapical radiograph 
to assess stage of 
root development 
and presence of 
radiolucency 
 
 
√ 
√ 
√ 

 
 
 
14- Sample size calculation: 
 
   Sample size is calculated based upon the results of Alqaderi et al (2014) [21] who 
reported clinical success rate (primary outcome) for MTA = 90%. Since no 
relevant literature reported the clinical success rate of Biodentine in permanent 
teeth of pediatric patients, the success rate was assumed to be 50%. Using alpha 
level = 0.05 and β level = 0.20 (80% Power); the minimum estimated sample size 
will be 20 subjects per group for a total of 40 subjects. To compensate for a drop-
out rate of 15%, the number is increased to 23 subjects per group for a total of 46 
subjects. 
Sample size calculation will be performed using IBM® SPSS® Sample 
Power® Release 3.0.1. 
15- Recruitment: 
 All patients attending the outpatient clinic in pediatric dentistry 
department complaining from traumatized immature permanent maxillary central 
incisors will be screened and enrolled in the study if they meet the eligibility 
criteria. 
16- Allocation: 
Sequence generation: 
Access cavity in traumatized central incisors will be assigned into experimental 
or control group using simple randomization 1:1 by the help of the computer 
software(random.org). 
 
Allocation concealment mechanism: 
Numbered opaque sealed envelopes. 
 
Implementation: 
The child will choose an envelope randomly and open it after access preparation 
so that the operator knows which pulpotomy agent will be used. Sequence 
generation will be done by the third author and the patient assignment will be 
done by the operator. 
17- Blinding: 
Patients and their parents, the assessor and the statistician will be blinded. 
 
18- Data collection methods: 
Primary outcome: 
Clinical assessment of the following findings: 
1. postoperative pain: through asking the child and the parent if there is pain 

 
 
either continuous or intermittent  
2. Swelling: through visual examination by the assessor either intraorally or 
extra-orally. 
3. Sinus or fistula through visual examination of the gingiva by the assessor. 
4. Tooth mobility: By the back of the mirror checked by the assessor to detect 
mobility in any direction 
This assessment will be conducted every follow-up visit throughout the study 
period at baseline, 6, 12 and 18 months. 
 Secondary outcome 
Radiographic assessment to detect stage of root development and presence of 
radiolucency through standardized periapical radiograph by parallel technique 
using film holder. This assessment will be conducted every follow-up visit 
throughout the study period at baseline, 6, 12 and 18 months. 
Postoperative records will be performed by the assessor to avoid individual 
variability and to promote data quality. 
 
19- Data management: 
Explanation to the parents about the importance of the follow-up visits in addition 
to treatment of other dental problems are plans to promotes participants retention 
and complete the follow-up. 
Also, phone calls before the dates before the next follow-up visit will be 
scheduled. 
All findings will be documented in the examination sheet then transferred 
electronically to computer in secured lace sequentially. 
 
20- statistical methods: 
 
All data will be collected, checked, revised, tabulated and entered into the 
computer. Qualitative data will be presented as frequencies and percentages. 
Quantitative data will be presented as mean and standard deviation values. Chi-
square test and Fisher’s Exact test will be used for comparisons regarding 
qualitative data. Student’s t-test will be used to compare between mean age values 
in the two groups. Friedman’s test will be used to study the changes by time 
within each group. Kaplan-Meier survival curve will be constructed to calculate 
the mean survival estimates of the two groups. Comparison between survival 
times will be performed using Log rank test. 
 
The significance level will be set at P ≤ 0.05. Statistical analysis will be 
performed with IBM® SPSS® Statistics Version 20 for Windows. 
 

 
 
21-Monitoring: 
The study data and results will be monitored regularly by the assessor who will 
have full access to these data. 
 
22- Harms: 
No reported adverse effects for both testing pulpotomy agents. Any adverse 
events appear during the trial will be recorded, documented and treated. 
  
23-Auditing: 
Auditing of the study design will be done by the evidence-based committee, 
Faculty of Dentistry -Cairo University. 
 
 V- Ethics and dissemination: 
 
24-Research ethics approval: 
This protocol and the template informed consent form will be reviewed by the 
Ethics Committee of Scientific Research - Faculty of Oral and Dental Medicine - 
Cairo University. 
 
25-Protocol amendments: 
Any modification to the protocol which may have an impact on the conduction 
of the study, potential benefit of the patient or my affect patient safety including, 
the changes of study objectives, study design, sample size or significant 
administrative aspects will require a formal amendment to the protocol. 
 
26-Consent and Assent: 
Researcher will discuss the trial with legal guardian of each participating child. 
They will be able to have an informed discussion with the researcher after 
explaining the procedure in simple words. Verbal assent will be taken orally from 
the participating child while written consent will be taken from the legal guardian 
of each participating child who is willing to participate in the trial. All consent 
forms will be translated into Arabic. 
 
27-confidentiality: 
All study related information will be stored securely. All participants information 
will be stored in locked file cabinets in an area with limited access. Process and 
administrative forms will be identified by a coded ID (identification number) only 
to maintain participants confidentiality. All records that contain names or other 
personal identifiers will be store separately from study records identified by code 
number 
 

 
 
28-Declration of interests: 
Non-financial. 
 
29- Access to data: 
All principal investigators will be given access to the data sets. All data sets will 
be password protected. To ensure confidentiality, data dispersed to study team 
members will be blinded of any identifying participants information. 
 
30-Ancillary and post-trial care: 
Full mouth treatment will be offered to all participating children in addition to 
postoperative care and preventive measures though regular follow up visits after 
the end trial. 
 
31- Dissemination policy: 
-Study results and articles will be published in related journal. 
 
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