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Идёт набор NCT06435780

Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects

Без фазы С лечением Defect in Alveolar Ridge

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: DIPRF.
Кому может быть актуально
Состояния в реестре: Defect in Alveolar Ridge. Базовые параметры: 18 лет — 50 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
Египет
Следующий шаг
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Официальное название

Evaluation of a Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects. A Randomized Controlled Clinical Trial

Обзор

The aim of the study is to clinically and radiographically evaluate and compare two techniques to augment soft tissues: the conventional subepithelial connective tissue graft technique and a novel denuded interpositional pedicled rolled flap technique (DIPRF) These techniques will be used to augment edentulous ridges that are recommended for rehabilitation by an implant or a fixed restoration.

Подробное описание

Fifty patients with soft tissue ridge contour defects in the maxillary premolar region and recommended for rehabilitation by an implant or a fixed restoration will be enrolled. Patients will be allocated randomly into two groups; group 1 (test group) will have augmentation for their soft tissue by a novel Denuded interpositional pedicled rolled flap technique (DIPRF); group 2 (control group) will be augmented by the conventional subepithelial connective tissue graft technique. Clinical volumetric change evaluation and ridge thickness analysis using digitally calibrated casts and CBCT analysis with a fusion software will be performed for every site as well as periodontal evaluation and patient centered outcomes, including pain and satisfaction after the procedure will be recorded for both techniques. For each site, an impression will be used to pour a cast that will be digitally scanned and vertical and horizontal ridge contours dimensions(tissue volumetric changes) will be recorded. These measurements will be obtained before the surgical procedure, 2 weeks, and 3 and 6 months post-surgical. CBCT analysis will be performed pre-operatively to confirm the diagnosis and eligibility of the case as having only soft tissue defect without bone defects, and 6 months postoperatively to analyze the amount of soft tissue gain in the two groups.

Вмешательства

  • Процедура DIPRF
    Denuded interpositional pedicled rolled flap technique

Первичные конечные точки

  • Ridge contour thickness gain [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Adults above the age of 18 to 50 years.
  • Males and females as confirmed by asking the female patients about whether they are pregnant or not
  • Patient's with Seibert classification class I requiring future rehabilitation of one or more premolar region and sound adjacent teeth.
  • Soft tissue thickness on the palatal tissues more than 6mm at the site of harvesting the graft.
  • Presence of Mandibular posterior teeth opposing the tooth to be replaced for occlusion.
  • Clinically healthy soft tissues with no signs of clinical pathology of the soft tissue.
  • Good oral hygiene.
  • Patient accepts to sign an informed consent.
  • ASA I or ASA II Patient.

Критерии исключения

  • Patients with ridge defects due to bone defect
  • Smoker patients who smoke more than 10 cigarettes per day
  • Pregnant females

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 · 1 центр
  • Misr International University — Cairo

Публикации

  • Scharf DR, Tarnow DP. Modified roll technique for localized alveolar ridge augmentation. Int J Periodontics Restorative Dent. 1992;12(5):415-25. PMID 1343013
  • Su H, Gonzalez-Martin O, Weisgold A, Lee E. Considerations of implant abutment and crown contour: critical contour and subcritical contour. Int J Periodontics Restorative Dent. 2010 Aug;30(4):335-43. PMID 20664835
  • Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part I. Technique and wound healing. Compend Contin Educ Dent (Lawrenceville). 1983 Sep-Oct;4(5):437-53. No abstract available. PMID 6578906
  • Meltzer JA. Edentulous area tissue graft correction of an esthetic defect. A case report. J Periodontol. 1979 Jun;50(6):320-2. doi: 10.1902/jop.1979.50.6.320. PMID 287786
  • Langer B, Calagna L. The subepithelial connective tissue graft. J Prosthet Dent. 1980 Oct;44(4):363-7. doi: 10.1016/0022-3913(80)90090-6. PMID 6931898
  • Kaldahl WB, Tussing GJ, Wentz FM, Walker JA. Achieving an esthetic appearance with a fixed prosthesis by submucosal grafts. J Am Dent Assoc. 1982 Apr;104(4):449-52. doi: 10.14219/jada.archive.1982.0209. PMID 6950973
  • Garber DA, Rosenberg ES. The edentulous ridge in fixed prosthodontics. Compend Contin Educ Dent (Lawrenceville). 1981 Jul-Aug;2(4):212-23. No abstract available. PMID 6950860
  • Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. No abstract available. PMID 6950834

Идентификаторы

NCT: NCT06435780 · FWA #00022887

Первоисточники (государственные реестры)

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