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Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Sponsor: Reem Mohamed Gaber
Summary
Dental caries in primary teeth can sometimes lead to inflammation of the dental pulp, the soft tissue inside the tooth. When the pulp remains capable of healing, pulpotomy may be performed to preserve the tooth until its natural exfoliation. During this procedure, bleeding from the remaining pulp tissue must be controlled before a pulp dressing material is placed. This randomized controlled clinical trial aims to compare the clinical and radiographic success of TheraCal PT pulpotomy in primary molars when three different solutions are used to control bleeding: 2.5% sodium hypochlorite, 15% ferric sulfate, and normal saline. Children aged 4-6 years who have primary molars diagnosed with reversible pulpitis and meet the study's eligibility criteria will be enrolled. Participants will be randomly assigned to one of three groups according to the hemostatic solution used during the pulpotomy procedure. TheraCal PT will be used as the pulpotomy material in all three groups. The treated teeth will be evaluated clinically at 3, 6, 9, and 12 months and radiographically at baseline, 6 months, and 12 months. The researchers will compare the outcomes among the three groups to determine whether the choice of hemostatic solution affects the success of TheraCal PT pulpotomy in primary molars. The findings may help improve understanding of the role of different hemostatic solutions in pulpotomy treatment for primary teeth.
Official title: Comparative Evaluation of Different Hemostatic Agents on Clinical and Radiographic Success of TheraCal PT Pulpotomy in Primary Molars With Reversible Pulpitis: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
4 Years - 6 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2027-01-01
Completion Date
2027-12-01
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%)
2.5% Sodium Hypochlorite applied to the root canal orifices/pulpal tissue for 3 minutes using a cotton pellet to achieve hemostasis prior to application of 2-mm TheraCal PT and final restoration with glass ionomer cement and a stainless steel crown and 15% Ferric Sulfate (Astringedent™ 15.5%) applied directly against the pulpal tissue/stumps for 1-3 minutes using a cotton pellet to achieve hemostasis prior to application of 2-mm TheraCal PT and final restoration with glass ionomer cement and a stainless steel crown and Sterile 0.9% Normal Saline applied with gentle pressure for 3 minutes using a moistened cotton pellet to achieve hemostasis prior to application of 2-mm TheraCal PT and final restoration with glass ionomer cement and a stainless steel crown
Locations (1)
Postgraduate Outpatients Clinic, Pediatric Dentistry Department, Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, Egypt