Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study

Официальное название

Comparative Evaluation of Melatonin Versus Mineral Trioxide Aggregate on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study

Обзор

The process of dental caries is dynamic and can be either reversible or irreversible depending on the balance between protective and pathologic factors in the oral cavity. Untreated dental caries causes pulpal injury, inflammation, and necrosis. Melatonin plays an essential role in the regulation of bone growth. The actions that melatonin exerts on odontoblasts may be similar to its action on osteoblasts.

Подробное описание

The aim of this study is to evaluate and compare the pulp response of young permanent first molars after apexogenesis procedure, using melatonin versus MTA clinically and radiographically. This study will be performed on 45 young permanent first molars that will be divided equally into three groups according to the material used following apexogenesis; GroupI: MTA, GroupII: Melatonin and GroupIII: MTA and Melatonin. apexogenesis procedures will be carried out in children aged 6 to 8 years old. This will be followed by placement of MTA or/and Melatonin material as a sub base in the pulp chamber according to the group. Then, placement of a conventional glass ionomer cement (FUGI IX) as a permanent restoration will be conducted. Then, an immediate postoperative periapical digital x-ray film will be taken for the patients. The patient follow-up will be assigned 1,3,6,9 and 12 months after treatment.

Вмешательства

• Препарат Mineral trioxide aggregate (dressing material)
  MTA (Angulus Industrial de productus Odontologists S/a, Brazil) that applied on dental pulp for tissue regeneration
• Препарат Melatonin (dressing material)
  melatonin powder 250mg (sigma, Aldrich)- white powder mixing with saline and applied on dental pulp

Первичные конечные точки

• Clinically assessment (Modified visual analogue scale) [Срок оценки: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months]
• Clinically assessment (Millar's index) [Срок оценки: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months]
• Clinically assessment (presence or abscence) [Срок оценки: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months]
• Radiographic assessment (using Image J software program) [Срок оценки: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months]
• Radiographic assessment (using Image J software program) [Срок оценки: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months]
• Radiographic assessment (using Image J software program) [Срок оценки: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months]
• Radiographic assessment (using Image J software program) [Срок оценки: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months]
• Radiographic assessment (using Image J software program) [Срок оценки: Immediately after apexogenesis procedure, after 1 month, 3 months, 6 months, 9 months and 12 months]

Критерии участия

Критерии включения

• 1- Apparently healthy and medically free children. 2- Their age ranges from 6-8 years. 3- Both boys and girls will be included. 4- Children should have mandibular permanent first molars with the following clinical and radiographic criteria. 4.1Restorable young permanent first molars. 4.2Absence of clinical evidence of pulp degeneration:
• No history of spontaneous pain, history of night pain or pain that not relieved by analgesics.
• No pain on percussion.
• No mobility.
• Absence of abscess, purulent sinus or soft tissue edema.
• Bleeding should stop within 5 minutes after the amputated pulp stumps.

Критерии исключения

• Internal root resorption.
• External root resorption.
• Inter radicular or periapical bone destruction (radiolucency)
• A deep carious lesion radiologically that approaches the pulp

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

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Medicine, Suez canal university — Ismailia

Публикации

• Guerrero-Girones J, Alcaina-Lorente A, Ortiz-Ruiz C, Ortiz-Ruiz E, Pecci-Lloret MP, Rodriguez-Lozano FJ, Martinez CM, Ortiz-Ruiz AJ. Melatonin as an Agent for Direct Pulp-Capping Treatment. Int J Environ Res Public Health. 2020 Feb 6;17(3):1043. doi: 10.3390/ijerph17031043. PMID 32041360
• Liu Q, Fan W, He Y, Zhang F, Guan X, Deng Q, Lu X, He H, Huang F. Effects of melatonin on the proliferation and differentiation of human dental pulp cells. Arch Oral Biol. 2017 Nov;83:33-39. doi: 10.1016/j.archoralbio.2017.06.034. Epub 2017 Jun 30. PMID 28692829
• Vaseenon S, Chattipakorn N, Chattipakorn SC. Effects of melatonin in wound healing of dental pulp and periodontium: Evidence from in vitro, in vivo and clinical studies. Arch Oral Biol. 2021 Mar;123:105037. doi: 10.1016/j.archoralbio.2020.105037. Epub 2021 Jan 6. PMID 33440268

Идентификаторы

NCT: NCT06372561 · Melatonin- vital pulp therapy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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