To Evaluate Periapical Healing Post Full Pulpotomy in Teeth With and Without Apical Periodontitis

Официальное название

To Evaluate Periapical Healing Post Full Pulpotomy in Permanent Mandibular Teeth With and Without Apical Periodontitis

Обзор

This clinical study aims to evaluate the periapical and clinical healing outcomes of full pulpotomy using MTA in mandibular permanent molars diagnosed with symptomatic irreversible pulpitis. Patients will be stratified based on the presence or absence of apical periodontitis. Clinical and radiographic assessments will be conducted at baseline, 6 months, and 12 months to compare healing outcomes between groups. The study seeks to determine the effectiveness of full pulpotomy as a less invasive alternative to root canal treatment, even in teeth with apical pathosis.

Подробное описание

This prospective clinical study aims to evaluate the periapical and clinical healing outcomes of full pulpotomy using mineral trioxide aggregate (MTA) in mandibular permanent molars diagnosed with symptomatic irreversible pulpitis. Patients will be stratified based on the presence or absence of apical periodontitis. Clinical and radiographic assessments will be conducted at baseline, 6 months, and 12 months to compare healing outcomes between groups. The study seeks to determine the effectiveness of full pulpotomy as a less invasive alternative to root canal treatment, even in teeth with apical pathosis.

Вмешательства

• Процедура Full pulpotomy in adults ≥18 years with restorable mandibular first or second molars diagnosed with irreversible pulpitis, with or without apical periodontitis.
  Comparison of full pulpotomy with MTA in teeth with and without apical periodontitis

Первичные конечные точки

• Success following complete pulpotomy [Срок оценки: 12 MONTHS]

Критерии участия

Критерии включения

• The patient should be ≥18 years of age.
• Restorable mature permanent 1st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement)
• Tooth should give positive response to pulp sensibility testing.
• Radiographic finding of periapical index (PAI) score >/=3 (for test group) , score </= 2 (for control group)

Критерии исключения

• Teeth with immature roots.
• No pulp exposure after caries excavation.
• Bleeding could not be controlled in 10 minutes.
• Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
• History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
• Internal/external resorption.
• Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индия · 1 центр

• PGIDS, Rohtak — Rohtak

Идентификаторы

NCT: NCT07179835 · Jigyasa Duhan

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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