Lesion Sterilization and Tissue Repair Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for Treatment of Primary Molars With Pulp Necrosis

Обзор

The goal of this clinical trial is to compare the efficacy of lesion sterilization and tissue repair (LSTR) antibiotic paste versus zinc oxide eugenol (ZOE) pulpectomy for the treatment of primary molars with pulp necrosis in pediatric patients. The main questions it aims to answer are: * Is LSTR antibiotic paste (CTZ paste) effective in treating primary molars with pulp necrosis? * Is ZOE pulpectomy effective in treating primary molars with pulp necrosis, and how does its efficacy compare with LSTR therapy? Researchers will compare LSTR therapy (Group A) with ZOE pulpectomy (Group B) to determine which treatment provides better clinical and radiographic outcomes after six months. Participants will: * Be randomly assigned to one of the two treatment groups after diagnosis of pulp necrosis in primary molars. * Receive treatment under standard behavior management techniques with local anesthesia following topical application of 2% lignocaine gel and rubber dam isolation. * Undergo either Lesion Sterilization and Tissue Repair (LSTR) therapy with CTZ paste or zinc oxide eugenol (ZOE) pulpectomy according to group allocation. * Return for a clinical and radiographic follow-up evaluation after six months to assess treatment outcomes. * Allow researchers to record their clinical findings and radiographic results to evaluate the efficacy of both treatment methods.

Вмешательства

• Препарат Group A - LSTR Therapy (CTZ Paste)
  Placement of CTZ antibiotic paste (chloramphenicol, tetracycline, zinc oxide mixed with eugenol) in the pulp chamber after irrigation with 3% sodium hypochlorite, followed by restoration with resin-modified glass ionomer cement.
• Процедура Group B - ZOE Pulpectomy
  Intervention: Conventional pulpectomy including working length determination, canal debridement with K-files and 3% sodium hypochlorite irrigation, followed by obturation with zinc oxide eugenol paste and final restoration with resin-modified glass ionomer cement.

Первичные конечные точки

• Number of Participants with Clinical Success [Срок оценки: 6 months]
• Number of Participants with Radiographic Success [Срок оценки: 6 months after treatment]

Вторичные конечные точки (1)

• Reduction in Periapical Radiolucency [Срок оценки: baseline and 6 months]

Критерии участия

Критерии включения

• • Children of both genders

• 4 years and 10 years
• Pulp necrosis in mandibular primary molars with minimum of 2/3 of the roots
• Consent from Parents/Guardian of children.
• Sufficient crown structure for restoration

Критерии исключения

• • Children who have a physical or mental change.

• Involving systemic illnesses.
• History of allergy to drugs being utilized
• Antibiotics use within three months
• Teeth with aberrant root resorption or pulp canal obliteration on periapical radiography

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07475364 · TUF/IRB/30/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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