Comparative Evaluation of Clinical and Radiographic Outcomes of Mustard Gel (Brassica Nigra) and Mineral Trioxide Aggregate (MTA) as Pulpotomy Agents in Deciduous Molars- A Randomized Controlled Trial

Обзор

The aim of this clinical trial is to compare two materials to treat baby molars with deep cavities. When the cavity is very deep and reaches the nerve of a baby tooth, dentist perform a treatment called "Pulpotomy". This means removing the damaged part of the nerve and placing medicament on healthy part to help tooth heal and stay pain-free until it falls out naturally. The standard medicine used today is Mineral Trioxide Aggregate (MTA) for treating baby molars that have deep cavities. It works well but is expensive and can darken the tooth. The study is testing a new medicine called Mustard Gel , made from black mustard seeds and may help heal the tooth. Mustard has natural healing and germ-fighting properties.This trial will help to compare Mustard Gel with MTA to see if the agent works to treat pulpitis. Children aged 6-8 years who need a pulpotomy procedure on a baby molar will be selected. During this procedure, infected part of the pulp tissue will be removed and medicament will be placed over the remaining healthy pulp. Selected participants will be put into one of the two groups by chance: 1. Mustard Gel Group : tooth will be treated with mustard gel after nerve removal 2. MTA Group : tooth will be treated with MTA, the current standard material. All the teeth will be sealed with a permanent filling material.Participants will be treated with both drugs and monitored after about 1 week, 1 month and 3 months to see if the tooth is pain-free and looks healthy on X-ray. The study will help check if Mustard gel is safe and if it causes any side effects.

Вмешательства

• Препарат Intervention 1: Mustard Gel
  Gel obtained from Brassica nigra (Black Mustard) seeds will be used as pulpotomy medicament in primary molars placed over pulp stumps after coronal pulp amputation. Approximately 1mm of mustard gel will be applied and tooth will be sealed with permanent filling material.
• Препарат Intervention 2 : Mineral Trioxide Aggregate (MTA)
  MTA will be mixed according to manufacturer's instructions and placed over the pulp stumps to a thickness of 1-2 mm using an amalgam carrier. It will be compressed gently with damp cotton pellet, the restored with glass-ionomer cement.

Первичные конечные точки

• Clinical and Radiographic success rate of Pulpotomy [Срок оценки: At 1 week, 1 month, 3 months post treatment.]

Критерии участия

Критерии включения

• healthy co-operative children 6-8 years old
• primary molars with deep cavities and iatrogenic pulp exposure
• clinically with no sign of spontaneous pain, sinus tract, tenderness to percussion, pathological mobility
• radiographically with absence of periapical radiolucency, internal/external root resorption, furcal radiolucency
• hemorrhage at the site of amputation controlled with 5 minutes
• tooth should be vital with healthy peridontium
• tooth should be restoreable

Критерии исключения

• teeth without permanent successor
• teeth with history of irreversible pulpitis
• post amputation unsuccessful hemorrhage control even after 5 minutes
• radiographic evidence of internal/external root resorption, furcal/periapical pathology
• patients with drug allergies or systemic diseases
• clinical signs of spontaneous pain, sinus tract, tenderness to percussion, pathological mobility

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: NCT07557290 · MG-MTA-Pulpotomy-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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