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

RecruitingPhase 2Ages 5 Years - 8 YearsAllDow University of Health Sciences
NCT07264842 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Lesion Sterilization and Tissue Repair using Simvastatin.
  • Lesion Sterilization and Tissue Repair using Triple Antibiotic Paste.
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Where

1 site
Dow International Dental College, Chanesar goth.
Karachi, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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