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

Официальное название

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

Обзор

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.

Вмешательства

• Комбинированный продукт 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.
• Комбинированный продукт 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.

Первичные конечные точки

• Clinical Success [Срок оценки: 1 month, 2 month and 3 month.]
• Radiographic success [Срок оценки: 1 month, 2 month and 3 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Dow International Dental College, Chanesar goth. — Karachi

Идентификаторы

NCT: NCT07264842 · 3379/DUHS//Approval/2024/175

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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