NCT07120321

Pulpotomy Materials in Primary Molars

Twelve-Month Prospective Evaluation of Clinical and Radiographic Outcomes of Pulpotomy Materials in Primary Molars

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Sacide Duman · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dental Caries
• Pulpitis

Interventions

Type	Name	Description
DRUG	Mineral Trioxide Aggregate (MTA)	Used as the capping agent after coronal pulp removal in primary molars.
DRUG	Biodentine	Used as a bioactive pulpotomy agent following coronal pulp amputation.
DRUG	Ferric Sulfate	15.5% Ferric Sulfate applied to pulp stumps for 15 seconds during pulpotomy procedure.
DRUG	Sodium hypochlorite gel application	5% NaOCl gel applied to pulp tissue during pulpotomy for its hemostatic and disinfectant effects.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-01-01
• Completion: 2025-07-01
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: Turkey (Türkiye)