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Идёт набор NCT06496828

Clinical Outcomes of Biologically Oriented Preparation Technique

Без фазы С лечением Crowns Tooth Preparation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Biologically-oriented preparation technique, Conventional method of preparation.
Кому может быть актуально
Состояния в реестре: Crowns, Tooth Preparation. Базовые параметры: 19 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Syria
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical Performance of All-Ceramic Crowns on Teeth Prepared With Biologically Oriented Preparation Technique Compared to Horizontal Preparation

Обзор

This study aims to evaluate the periodontal response of teeth prepared with a biologically oriented preparation technique (BOPT) compared to conventional preparation for all-ceramic crowns.

Подробное описание

The study aims to evaluate the clinical performance of all-ceramic crowns on teeth prepared with two different types of preparations.

This randomized controlled trial will include 60 teeth divided into two groups: 30 teeth will be prepared with BOPT, and 30 teeth will be prepared with shoulder margins. All teeth will receive monolithic or bi-layered ceramic crowns.

Patients are planned to attend follow-up visits after 3, 6, 12, and 18 months, respectively, after cementation. Probing depth, gingival recession, bleeding on probing, gingival index, gingival thickness, patient opinion, and mechanical and biological complications are all recorded at check-up appointments.

Вмешательства

  • Процедура Biologically-oriented preparation technique
    The preparation will be made according to the new principles of biologically oriented technique to receive monolithic and bi-layered all-ceramic crowns.
  • Процедура Conventional method of preparation
    Teeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns

Первичные конечные точки

  • Change in the Plaque index [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
  • Change in the gingival index [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
  • Change in the probing depth [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
  • Change in bleeding on probing [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
  • Change in the gingival marginal stability [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
  • Change in the free gingiva thickness [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.]
Вторичные конечные точки (7)
  • Change in the internal and marginal adaptation [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in the functional and mechanical complications [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in the secondary caries status [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in the marginal adaptation after crown cementation [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in the color matching [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in the clinical success [Срок оценки: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.]
  • Change in patients' satisfaction [Срок оценки: This will be measured at one week and 18 months following cementation.]

Критерии участия

Критерии включения

  • Patients older than 18.
  • Two teeth at least needed to be restored with full crowns (each patient needs at least two single crowns).
  • Stable occlusion.
  • Good oral hygiene.
  • Periodontally healthy teeth.
  • Nonsmoking or smoking less than ten cigarettes/day.
  • Probing depth between 1 and 3 mm.

Критерии исключения

  • Patients younger than 18.
  • Parafunctional habits.
  • Active periodontal disease.
  • Poor oral hygiene.
  • Systemic disease that may affect the periodontal health.
  • Pregnancy.
  • Radiation or chemotherapy.
  • Treatment by Bisphosphonates medication.
  • Patients who are unable or unwilling to attend follow-up visits

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Syria · 1 центр
  • Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria — Damascus

Публикации

  • Mohammad A, Abraham S, Nada A. The effect of biologically oriented and subgingival horizontal preparation techniques on periodontal health: A double-blind randomized controlled clinical trial. Saudi Dent J. 2023 Sep;35(6):727-733. doi: 10.1016/j.sdentj.2023.06.003. Epub 2023 Jun 17. PMID 37817795
  • Palombo D, Rahmati M, Vignoletti F, Sanz-Esporrin J, Salido MP, Haugen HJ, Sanz M. Hard and soft tissue healing around teeth prepared with the biologically oriented preparation technique and restored with provisional crowns: An in vivo experimental investigation. J Clin Periodontol. 2023 Sep;50(9):1217-1238. doi: 10.1111/jcpe.13825. Epub 2023 May 30. PMID 37253614
  • Agustin-Panadero R, Serra-Pastor B, Loi I, Suarez MJ, Pelaez J, Sola-Ruiz F. Clinical behavior of posterior fixed partial dentures with a biologically oriented preparation technique: A 5-year randomized controlled clinical trial. J Prosthet Dent. 2021 Jun;125(6):870-876. doi: 10.1016/j.prosdent.2020.03.031. Epub 2020 Jun 21. PMID 32580920
  • Serra-Pastor B, Bustamante-Hernandez N, Fons-Font A, Fernanda Sola-Ruiz M, Revilla-Leon M, Agustin-Panadero R. Periodontal Behavior and Patient Satisfaction of Anterior Teeth Restored with Single Zirconia Crowns Using a Biologically Oriented Preparation Technique: A 6-Year Prospective Clinical Study. J Clin Med. 2021 Aug 6;10(16):3482. doi: 10.3390/jcm10163482. PMID 34441778
  • Agustin-Panadero R, Serra-Pastor B, Fons-Font A, Sola-Ruiz MF. Prospective Clinical Study of Zirconia Full-coverage Restorations on Teeth Prepared With Biologically Oriented Preparation Technique on Gingival Health: Results After Two-year Follow-up. Oper Dent. 2018 Sep/Oct;43(5):482-487. doi: 10.2341/17-124-C. Epub 2018 Mar 7. PMID 29513640
  • Paniz G, Nart J, Gobbato L, Chierico A, Lops D, Michalakis K. Periodontal response to two different subgingival restorative margin designs: a 12-month randomized clinical trial. Clin Oral Investig. 2016 Jul;20(6):1243-52. doi: 10.1007/s00784-015-1616-z. Epub 2015 Oct 8. PMID 26445857
  • Loi I, Di Felice A. Biologically oriented preparation technique (BOPT): a new approach for prosthetic restoration of periodontically healthy teeth. Eur J Esthet Dent. 2013 Spring;8(1):10-23. PMID 23390618

Идентификаторы

NCT: NCT06496828 · UDDS-Prosthodontics-01-2024

Первоисточники (государственные реестры)

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