Clinical and Radiographic Assessment of Bio C Repair, Biodentine and Mineral Trioxide Aggregate

Официальное название

Clinical and Radiographic Assessment of Bio C Repair, Biodentine and Mineral Trioxide Aggregate Used As Pulpotomy Agents In Vital Immature Permanent Molars With Irreversible Pulpits. A Randomized Control Trial

Обзор

The aim of this study is to assess Clinical and Radiographical effect of Bio C repair, Biodentine and Mineral Trioxide Aggregate when used as pulpotomy Agents in Immature Permanent Molars with Pulpits.

Вмешательства

• Другое Biodentine
  First introduced in 2009 as a "dentin replacement" agent, biodentin is a "bioactive replacement for dentine." It is also available under the trade name Septodont. The material is reported to have better physical and biological properties than other tricalcium silicate cements such mineral trioxide aggregate (MTA) an d BioaggregateTM.
• Другое Bio C repair
  A new calcium silicate-based restorative cement called Bio-C Repair (Angelus, Londrina, Brazil) exhibits bioactivity and promotes tissue repair and biomineralisation. This material has a number of benefits, including reduced susceptibility to moisture as compared to traditional substitutes and easy application via a convenient single-use syringe size, which improves clinical efficacy. (Torres et al., 2020). By encouraging bioactivity, biomineralisation, and hard tissue repair, Bio C Repair is u

Первичные конечные точки

• Radiographic examination of complete apical closure [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Presence of pain [Срок оценки: 12 months]
• The presence of Swelling [Срок оценки: 12 months]
• The presence of Sinus or fistula [Срок оценки: 12 months]
• tenderness associated with the tooth. [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Children aged 6-10 years with asymptomatic/symptomatic disease and having vital immature permanent posterior teeth with clinical exposure to dental caries of the pulp and bleeding.
• Posterior teeth had deep caries with pulp exposure.
• Posterior teeth that exhibited preoperative symptoms, such as referred pain, spontaneous pain or pain induced during thermal and cold sensitivity tests, with a range of symptoms that can last from seconds to hours compared to the control teeth.
• Posterior teeth without prominent radiolucency in the furcation or periapical regions.
• The posterior teeth could be restored.
• Children with prior parental consent.

Критерии исключения

• • (1) Patients with contraindications of the to-be-performed dental treatment.

• (2) Teeth with completed VPT or RCT.
• (3) Teeth with furcation, prominent radiolucency in the periapical regions, or external or internal resorption.
• (4) Teeth with pulpitis attributed to tooth fracture, cracking, periodontitis or wedge-shaped defects.
• (5) Teeth without any response to experiments of vitality. (
• 6\) Teeth with formed root/closed apex.
• (7) Teeth with edema, fistula and excessive mobility not associated with periodontal disease.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07522723 · 4-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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