Pulpotomy Materials in Primary Molars

Not Applicable

Completed

• Conditions: Dental Caries; Pulpitis
• Interventions: Drug: Mineral Trioxide Aggregate (MTA); Drug: Biodentine; Drug: Ferric Sulfate; Drug: Sodium hypochlorite gel application

• Registration Number: NCT07120321
• Lead Sponsor: Sacide Duman

Brief Summary

This randomized clinical trial aims to compare four different materials used in a dental procedure called pulpotomy. Pulpotomy is commonly performed on primary molars (back teeth in children) to treat deep cavities and preserve the tooth. Children aged 4 to 7 who need this procedure will receive one of four materials: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate, or Sodium Hypochlorite gel. The treated teeth will be checked at 6 and 12 months to evaluate the success of each material. The goal is to identify the most effective and reliable material for pulpotomy in primary molars.

Detailed Description

Vital pulpotomy is a conservative and widely used treatment to maintain the function of primary molars affected by deep carious lesions. The choice of pulpotomy medicament plays a significant role in the long-term success of the procedure.

This randomized clinical trial is designed to compare the clinical and radiographic success rates of four pulpotomy agents: Mineral Trioxide Aggregate (MTA), Biodentine, Ferric Sulfate (FS), and Sodium Hypochlorite gel (NaOCl gel).

A total of 88 mandibular second primary molars in children aged 4 to 7 years will be included. After coronal pulp removal, one of the four materials will be applied to the pulp tissue. All treated teeth will be restored with stainless steel crowns. Follow-up evaluations will be performed at 6 and 12 months to assess the clinical and radiographic success of each material.

The findings from this study are expected to help determine the most effective and reliable pulpotomy material for use in pediatric dentistry.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-07-01
• Study First Submitted: 2025-07-21
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Children aged between 4 and 7 years
• At least one primary molar indicated for pulpotomy
• No spontaneous pain or systemic infection
• Cooperative behavior according to the Frankl Behavior Rating Scale (scores 3 or 4)
• Signed informed consent from parents or legal guardians

Exclusion Criteria

• Medically compromised children or presence of systemic diseases (e.g., bleeding disorders, immunodeficiency)
• Uncooperative behavior (Frankl rating 1 or 2)
• Primary teeth with signs of pulpal necrosis, abscess, sinus tract, or non-restorable crown
• History of allergy to any materials used in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MTA Group	Mineral Trioxide Aggregate (MTA)	Primary molars treated with Mineral Trioxide Aggregate (MTA) as the pulpotomy medicament.
Biodentine Group	Biodentine	Primary molars treated with Biodentine as the pulpotomy medicament.
Ferric Sulfate Group	Ferric Sulfate	Primary molars treated with 15.5% Ferric Sulfate as the pulpotomy medicament.
Sodium Hypochlorite Gel Group	Sodium hypochlorite gel application	Primary molars treated with 5% Sodium Hypochlorite gel as the pulpotomy medicament.

Primary Outcome Measures

Name	Time	Method
Number of participants with clinical success after pulpotomy in primary molars	12 months after pulpotomy	Clinical success is defined as the absence of spontaneous pain, swelling, sinus tract, or abnormal mobility in the treated tooth during clinical examination.

Secondary Outcome Measures

Name	Time	Method
Number of participants with radiographic success after pulpotomy in primary molars	12 months after pulpotomy	Radiographic success is defined as the absence of internal/external root resorption, periapical or furcal radiolucency, and periodontal ligament widening.

Trial Locations

Locations (1)

Inonu University, Faculty of Dentistry, Department of Pediatric Dentistry; 🇹🇷 Malatya, Turkey