Twelve-Month Prospective Evaluation of Clinical and Radiographic Outcomes of Pulpotomy Materials in Primary Molars
Phase: NA
Conditions: Dental Caries, Pulpitis
Sponsor: Sacide Duman

 
OFFICIAL TITLE: Twelve-Month Prospective Evaluation of Clinical and Radiographic 
Outcomes of Pulpotomy Materials in Primary Molars  
NCT Number: not yet assigned 
Document Date: June 28, 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1. Background  
Pulpotomy is a widely accepted treatment modality for cariously exposed primary molars. While 
several medicaments have shown favorable outcomes, the comparative effectiveness of emerging 
and traditional materials within the same patient cohort remains understudied. This study aims to 
prospectively evaluate the clinical and radiographic outcomes of four pulpotomy medicaments—
MTA, Biodentine, Ferric Sulfate, and Sodium Hypochlorite—using a split-mouth randomized 
controlled trial design over a 12-month period.  
2. Study Objectives  
Primary Objective: To compare the 12-month clinical and radiographic success rates of MTA, 
Biodentine, Ferric Sulfate, and Sodium Hypochlorite in pulpotomy treatment of primary molars.  
Secondary Objective: To determine the feasibility and effectiveness of a split-mouth design for 
pulpotomy comparisons in pediatric patients.  
3. Study Design  
Design Type: Prospective, split-mouth, randomized controlled clinical trial.  
Participants: Healthy children aged 4–7 requiring pulpotomy in four primary molars due to deep 
caries.  
Sample Size: A priori power analysis determined that at least 19 patients were required to detect 
statistically significant differences.  
Randomization: Performed at the tooth level within each patient using sealed opaque envelopes 
prepared by an independent researcher. Clinical and radiographic assessors were blinded to 
treatment groups.  

Inclusion Criteria:  
Age between 4 and 7 years  
Four primary molars indicated for pulpotomy due to deep caries  
Clinical signs of reversible pulpitis only  
Restorable teeth with normal periapical radiographs  
Exclusion Criteria:  
Systemic illness  
Teeth with signs of irreversible pulpitis or radiographic pathology  
Uncooperative behavior impeding treatment  
5. Interventions and Procedures  
Local Anesthesia: 2% Lidocaine with 1:100,000 epinephrine  
Isolation: Rubber dam  
Access: High-speed handpiece with sterile water-cooled diamond bur  
Coronal Pulp Removal: Low-speed round bur  
Hemostasis: Achieved with sterile water-moistened cotton pellet  
Groups and Materials:  
Group I: 15.5% Ferric Sulfate – 15 s application  
Group II: 5.25% Sodium Hypochlorite Gel – 1 min application  
Group III: MTA – ~2 mm thick layer  
Group IV: Biodentine – full chamber fill  
Restoration:  
Groups I–III: IRM base + stainless steel crown  
Group IV: Biodentine fill + stainless steel crown  
All crowns cemented with glass ionomer cement (Fuji I)  
All procedures were performed by a single experienced pediatric dentist.  
6. Follow-up and Outcome Measures  
Follow-up Schedule:  
Clinical: 3, 6, and 12 months  
Radiographic: 6 and 12 months  
Success Criteria:  
Clinical: No pain, swelling, abscess, fistula, percussion sensitivity, or mobility  
Radiographic: No furcation/periapical pathology, no internal resorption; Pulp canal obliteration 
was not deemed a failure  
 

Evaluator Blinding:  
Clinical evaluation by two independent, blinded pediatric dentists  
Radiographic evaluation by a blinded pediatric dentist and radiologist  
Disagreements were resolved through consensus. No pulp chamber masking was done, 
introducing a possible bias.  
7. Statistical Analysis  
All statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS 
Version 26; IBM Corp., Armonk, NY, USA). Fishers exact test was used to compare clinical and 
radiographic outcomes at the 6- and 12-month follow-ups among the four groups. Success and failure 
rates were calculated based on a per-protocol analysis, which included 22 patients per group. Patients 
who did not complete the study protocol were excluded from the analysis. In addition, Cochrans Q test 
was applied to compare the clinical and radiographic success rates of the four pulpotomy materials 
(Biodentine, MTA, NaOCl, and Ferric Sulfate) at the 12-month follow-up. Treatment outcomes were 
dichotomized as success or failure. The test was calculated using data from all 22 patients in each 
group. The significance level was set at p < 0.05.  
8. Ethical Considerations  
Approval was obtained from Interventional Clinical Research Ethics Committee, (Approval No: 
2021/77).  
Written informed consent was obtained from the parents/legal guardians of all participants.  
The study adhered to the Declaration of Helsinki and national regulations on human research 
ethics.  
9. Data Handling and Confidentiality  
All data will be anonymized and stored securely in password-protected databases accessible only 
to the research team. Personal identifiers will be removed during data analysis and reporting.