Clinical Performance and Antibacterial Effect of Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars

Официальное название

Clinical Performance and Antibacterial Effect of a Bulk Fill Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars(Randomized Controlled Clinical Trial)

Обзор

The study aims to evaluate the clinical performance of Cention-Forte (CF) material in the restoration of pulpotomized second primary molars compared to conventional stainless steel crowns (SSC), and also to assess the restorations' antibacterial effect on salivary cariogenic bacterial count.

Подробное описание

A two-arm randomized controlled clinical trial. A total of 40 healthy cooperative children aged 5-9 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Each child selected will have second primary molar with occluso-proximal carious lesions indicated for pulpotomy. Written informed consent will be obtained from their guardians. After the MTA pulpotomy procedure, participants will be randomly allocated into two groups according to the restoration used. Group I (test group n=20) will receive Cention Forte material, while group II (control group n=20) will receive conventional SSC. Using Modified Ryge's Criteria, the clinical performance of the restorations will be evaluated at 1 week and then after 3, 6 and 12 months for marginal adaptation, proximal contact, retention, gross fracture, occlusal wear, surface roughness and secondary caries. Periapical radiographs will be taken at baseline and after 6 and 12 months. Also, the antibacterial effect of the restorations on salivary cariogenic bacterial count will be assessed at baseline and after 1 week, 1 month and 3 months. Plaque and Gingival index scores as well as parental and child's satisfaction will be recorded.

Data will be collected, tabulated, and statistically analysed to obtain the results and conclusions of this study.

Вмешательства

• Другое Cention Forte alkasite bioactive restorative material
  Cention forte material will be used as a final restoration for pulpotomized second primary molars
• Другое Stainless steel crown
  The control group using the gold standard stainless steel crown (SSC) as a final restoration for pulpotomized second primary molars

Первичные конечные точки

• Clinical performance of the restorations using Modified Ryge's Criteria [Срок оценки: One year]
• The antibacterial effect of both restorations on salivary cariogenic bacterial count. [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Radiographic success of pulpotomized second primary molars in both groups [Срок оценки: One year]
• Gingival index [Срок оценки: One year]
• Plaque index [Срок оценки: One year]
• Child satisfaction [Срок оценки: Over one year]
• Parental satisfaction [Срок оценки: Over one year]

Критерии участия

Критерии включения

• Cooperative children (Positive or definitely positive) according to the Frankl's behaviour rating scale.
• Children free of any systemic disease or special health care needs (ASA1).
• Completion of an informed consent to participate in the study.
• Second primary molar tooth with occluso-proximal carious lesions indicated for pulpotomy.
• Restorable tooth.
• Radiographically at least two-thirds of the root length is present.
• Presence of neighboring and opposing teeth.

Критерии исключения

• Clinical signs or symptoms of irreversible pulpitis or non- vitality.
• Radiographic signs of degeneration including internal or external root resorption, furcation involvement.
• Pathologic mobility detected by placing the points of a pair of tweezers in the occlusal fossa and gently rocking the tooth buccolingually.
• Reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes within the last 2 weeks.
• Child with parafunctional habits.

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

Египет · 2 центра

• Faculty of Dentistry, Alexandria University — Alexandria
• Faculty of Pharmacy, Alexandria University — Alexandria

Идентификаторы

NCT: NCT07094854 · Noha Fouad

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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