NCT07264842

Triple Antibiotic Paste vs Simvastatin for Lesion Sterilization and Tissue Repair in Primary Molars.

Triple Antibiotic Paste Versus Simvastatin for LSTR Treatment of Primary Molars With Pulp Necrosis: A Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Dow University of Health Sciences · Academic / Other
• Sex: All
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blinded, parallel-controlled clinical trial aims to compare the effectiveness of Triple Antibiotic Paste (TAP) and Simvastatin in Lesion Sterilization and Tissue Repair (LSTR) of primary molars with pulp necrosis. A total of 60 children (aged 5-8 years) with non-vital primary molars will be recruited from the Department of Operative Dentistry and Endodontics, Dow International Dental College, Karachi. Participants will be randomly assigned to one of two groups: Group 1 (Control): LSTR using Triple Antibiotic Paste (Ciprofloxacin + Metronidazole + Cefixime). Group 2 (Intervention): LSTR using Simvastatin paste. Both materials will be placed after non-instrumentation cleaning and sealed with glass ionomer cement, followed by stainless steel crown placement. Patients will be evaluated clinically and radiographically at 1, 2, and 3 months post-treatment. Primary outcomes include clinical success (absence of pain, swelling, or sinus tract) and radiographic success (reduction or absence of periapical radiolucency). Data will be analyzed using SPSS v26, with chi-square and t-tests applied as appropriate; p \< 0.05 will be considered significant. This study seeks to determine whether Simvastatin, owing to its antibacterial, anti-inflammatory, and regenerative properties, can serve as a viable alternative to antibiotic-based LSTR in managing necrotic primary teeth.

Conditions

• Pulpal Necrosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Lesion Sterilization and Tissue Repair using Simvastatin.	Lesion sterilization and Tissue Repair includes removal of any debris from the pulp chamber of the primary tooth and filling with simvastatin followed by sealed with the restoration.
COMBINATION_PRODUCT	Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste.	Lesion sterilization and Tissue Repair includes removal of any debris from the pulp chamber of the primary tooth and filling with triple antibiotic paste followed by sealed with the restoration.

Timeline

• Start date: 2024-06-26
• Primary completion: 2026-04-30
• Completion: 2026-07-31
• First posted: 2025-12-04
• Last updated: 2026-03-10

Locations

1 site across 1 country: Pakistan