Clinical and Radio-graphic Evaluation of Non-staining Bio-active Bio-ceramic (Neo MTA 2) in Revascularization

Официальное название

Clinical and Radio-graphic Evaluation of Bio-active Bio-ceramic (Neo MTA 2) Versus White MTA Used as Coronal Plug Material in Revascularization of Non-vital Immature Permanent Anterior Teeth: A Randomized Clinical Trial

Обзор

The study will compare the clinical and radio-graphic performance of newly introduced non-staining bio-active bio-ceramic (Neo MTA 2) versus White MTA used as coronal plug material in revascularization of non-vital immature permanent anterior teeth.Visual examination, palpation, A measuring scale in digital radio-graph software (DIGORA for Windows software) will be used for evaluation.

Подробное описание

Mineral trioxide aggregate (MTA) has been widely used in revascularization procedures for coronal sealing in more than 85% of studies for privilege of bio compatibility, good sealing properties, and marginal adaptation. However, its poor handling characteristics and potential coronal discoloration effects are the major disadvantages of using mineral trioxide aggregate.

Although white MTA (WMTA) has been developed to overcome the tooth discoloration caused by the application of grey MTA, several in vivo and in vitro studies have also reported tooth discoloration after using WMTA.

To overcome the problems associated with WMTA, a new modification was introduced to the market called NeoMTA 2 as a new hope to overcome the discoloration problem. NeoMTA 2 provides easier handling, shorter setting time, and better color. The lack of post-operative discoloration problems was mainly due to the absence of Bismuth oxide in NeoMTA.

up to date, no clinical trials have reported the clinical and radio-graphic outcomes after revascularization of non-vital immature permanent anterior teeth using Neo MTA 2. Thus, the present study aims to evaluate and compare clinically and radio-graphically the effect of using two different coronal plug materials (Neo MTA 2 versus White mineral trioxide aggregate) in revascularization of non-vital immature permanent anterior teeth.

Вмешательства

• Препарат NeoMTA2
  Bio-active bio-ceramic mineral trioxide aggregate
• Препарат WMTA
  White Mineral trioxide aggregates

Первичные конечные точки

• Discoloration [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Cooperative patient/ compliant parents or guardians
• Patients free from any systemic diseases that hinder the normal healing process according to parental history
• Necrotic immature permanent anterior teeth
• Enough coronal portion of teeth that does not necessitate post and core for final restoration

Критерии исключения

• Patients having an allergy to medicament and antibiotics necessary to complete the procedure
• Teeth with internal or external root resorption
• Uncooperative patients/ in-compliant parents or guardians
• Laxative injuries
• Avulsed tooth after re-plantation
• Compromised remaining coronal structure

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06637761 · Cairo U Clinical

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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