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

NCT ID: NCT07264842

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-26
• Study Completion Date: 2026-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Simvastatin

Lesion Sterilization and Tissue Repair using Simvastatin.

Group Type: EXPERIMENTAL

Lesion Sterilization and Tissue Repair

Intervention Type: COMBINATION_PRODUCT

Lesion sterilization and Tissue Repair includes removal of any debris from the pulp chamber of the primary tooth and filling with triple antibiotic paste or simvastatin followed by sealed with the restoration.

Triple Antibiotic Paste

Lesion Sterilization and Tissue Repair using triple antibiotic paste

Group Type: ACTIVE_COMPARATOR

Lesion Sterilization and Tissue Repair

Intervention Type: COMBINATION_PRODUCT

Lesion sterilization and Tissue Repair includes removal of any debris from the pulp chamber of the primary tooth and filling with triple antibiotic paste or simvastatin followed by sealed with the restoration.

Interventions

Lesion Sterilization and Tissue Repair

Lesion sterilization and Tissue Repair includes removal of any debris from the pulp chamber of the primary tooth and filling with triple antibiotic paste or simvastatin followed by sealed with the restoration.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Young, healthy patient, ranging in age from 5-8 years.
• Has parents/ guardians who give consent to allow their minor to participate in the study and willing to monitor their progress.
• Having maxillary and mandibular primary molars with:

• Spontaneous pain or tenderness to percussion.
• Deep cavity extending to the pulp chamber.
• Chronic Abscess or draining sinus.
• Restorable.
• To be kept for less than a year.
• Irregular mobility that is not related to exfoliation.

Exclusion Criteria

• Uncooperative patients.
• Children with a history of allergic reaction with antibiotics.
• Teeth with physiological root resorption but root length is more than two thirds, root canal obliteration, severe internal resorption, internal calcifications, or piercing into the bifurcation.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Waleed Mumtaz

Postgraduate Trainee- FCPS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof.Dr. Farah Naz Biyabani, FCPS

Role: STUDY_DIRECTOR

Dow University of Health Sciences

Locations

Dow International Dental College, Chanesar goth.

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Muhammad Waleed Postgraduate Trainee, FCPS

Role: CONTACT

waleedmumtaz.401194@duhs.edu.pk

923222046451

Prof. Dr. Farah Naz Supervisor, FCPS

Role: CONTACT

farah.naz@duhs.edu.pk

03002345434

Facility Contacts

Muhammad Waleed Postgraduate Trainee - FCPS, BDS

Role: primary

waleedmumtaz.401194@duhs.edu.pk

923222046451

Prof.Dr. Farah Naz Supervisor, FCPS

Role: backup

farah.naz@duhs.edu.pk

03002345434

Other Identifiers

3379/DUHS//Approval/2024/175

Identifier Type: -

Identifier Source: org_study_id