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

Phase 2RecruitingNCT07264842

Dow University of Health Sciences60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pulpal Necrosis

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.

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 8 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Clinical Success

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

Time frame: 1 month, 2 month and 3 month.

Radiographic success

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

Time frame: 1 month, 2 month and 3 month