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

NCT07264842 | Recruiting Phase 2 DMC

• 1 other identifier: 3379/DUHS//Approval/2024/175
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Lesion Sterilization and Tissue Repair

Outcome Measures

Primary Outcomes (2)

• Clinical Success

  Change in pain through visual analog scale and size of swelling in millimeters will be assessed to measure clinical success.

  1 month, 2 month and 3 month.

• Radiographic success

  Change in radiolucency through the periapical index will be measured to assess radiographic success.

  1 month, 2 month and 3 month

Study Arms (2)

Simvastatin

EXPERIMENTAL

Lesion Sterilization and Tissue Repair using Simvastatin.

Combination Product: Lesion Sterilization and Tissue Repair using Simvastatin.

Triple Antibiotic Paste

ACTIVE COMPARATOR

Lesion Sterilization and Tissue Repair using triple antibiotic paste

Combination Product: Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste.

Interventions

Lesion Sterilization and Tissue Repair using Simvastatin. COMBINATION_PRODUCT

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.

Simvastatin

Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste. 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 followed by sealed with the restoration.

Triple Antibiotic Paste

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow International Dental College, Chanesar goth.

Karachi, Sindh, 75950, Pakistan

RECRUITING

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof.Dr. Farah Naz Biyabani, FCPS

  Dow University of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Muhammad Waleed Postgraduate Trainee, FCPS

CONTACT

923222046451; waleedmumtaz.401194@duhs.edu.pk

Prof. Dr. Farah Naz Supervisor, FCPS

CONTACT

03002345434; farah.naz@duhs.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Trainee- FCPS

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: June 26, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

PA (1)