Deep Caries in Mature Teeth With Reversible Pulpitis

Официальное название

Clinical, Radiographical, and Histological Evaluation of Treatment Outcomes Following Different Caries Removal Strategies in Mature Permanent Teeth With Reversible Pulpitis (A Randomized Clinical Trial and Ex-vivo Study)

Обзор

This clinical trial will be conducted to clinical, radiographical and histological evaluation of pulp condition with reversible pulpities after total and selective removal of primary and secondary caries (randomized clinical trial and exo-vivo study)

Подробное описание

Randomized clinical trial Sample size 144 case…

Randomization method used:

Sample size calculation was performed using R statistical analysis software version 4.3.2 for Windows

Outcome variables:

Pulp vitality and post operative pain Grouping classified into four groups as follows: The first group : total caries removal of primary caries(PTCR) 27 The second group: selective caries removal of primary caries(PSCR) The third group: total caries removal of secondary caries(STCR) The fourth group : selecive caries removal of secondary caries(SSCR)

Expected Time table:

2 years Recall of patient after 3,6,9 and 12 months 6 months for writing and 6 months for data analyzed

Вмешательства

• Процедура Total caries removal
  Total caries removal and application of bioactive material
• Процедура Partial caries removal
  Partial caries removal then application of biodentin

Первичные конечные точки

• clinical evaluation ………. Radiographic evaluation: [Срок оценки: 1year]

Вторичные конечные точки (1)

• histological evaluation and follow up [Срок оценки: 1 year]

Критерии участия

Критерии включения

• The patient's age from 18 years to 40 years old
• Non -contributory medical history (ASA1)
• Mature permanent posterior teeth with primary or secondary deep caries extending ≥ 2/3 of dentin
• The tooth should give a positive response to cold testing
• Clinical diagnosis of reversible pulpitis
• The tooth is restorable via direct restoration, probing pocket depth and mobility are within normal limits
• No signs of pulpal necrosis including sinus tract or swelling
• No radiographic evidence of periapical changes indicative of apical periodontitis

Критерии исключения

• Systemic medical conditions, pregnancy, alcoholic and smoker patients. 2- Teeth with spontaneous pain or percussion sensitivity in periodontal lesions, external or internal root resorption, sinus opening, mobility, or abscessed tooth. 3- Radiographic evidence of widened periodontal space, broken or interrupted lamina dura, and periapical radiolucency. 4- Intensified erosion damage or periodontitis. Patient reported clenching or bruxism, hopeless or non-restorable teeth. Immature teeth. 5- Patients with physical disabilities preventing tooth brushing. Patient had removable partial denture abutments, dental abscesses, pulp lesions, atypical facial pain, or pulpitis. 6- Patients had non-carious lesions like abrasion, erosion, attrition, or abfraction.

7- Patients with history of antibiotic or analgesics intake within few days of operative intervention. 8- Patients with previously root canal-treated teeth. 9- Periodontally compromised teeth. 10-Teeth that will be extracted for periodontal or orthodontic reasons as it will conduct for histological evaluation

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

Список центров уточняется — проверьте первичный протокол.

Публикации

• Taha NA, Ali MM, Abidin IZ, Khader YS. Pulp survival and postoperative treatment needs following selective vs. total caries removal in mature permanent teeth with reversible pulpitis: A randomized clinical trial. J Dent. 2024 Dec;151:105408. doi: 10.1016/j.jdent.2024.105408. Epub 2024 Oct 22. PMID 39442480
• Ahlawat M, Grewal MS, Goel M, Bhullar HK, Saurabh, Nagpal R. Direct Pulp Capping with Mineral Trioxide Aggregate and Biodentine in Cariously Exposed Molar Teeth: 1-Year Follow-up - An In vivo Study. J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S983-S985. doi: 10.4103/jpbs.jpbs_837_21. Epub 2022 Jul 13. PMID 36110733
• Drouri S, El Merini H, Sy A, Jabri M. Evaluation of Direct and Indirect Pulp Capping With Biodentine in Vital Permanent Teeth With Deep Caries Lesions. Cureus. 2023 May 23;15(5):e39374. doi: 10.7759/cureus.39374. eCollection 2023 May. PMID 37250608

Идентификаторы

NCT: NCT07028905 · deep caries in mature teeth

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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