Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries

Официальное название

Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study

Обзор

Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.

Подробное описание

This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Вмешательства

• Процедура Connective tissue graft
  non-surgical periodontal treatment and connective tissue graft
• Процедура Free gingival graft
  will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft
• Процедура Non surgical
  non-surgical periodontal treatment only

Первичные конечные точки

• Gingival phenotype change [Срок оценки: at baseline 3,6 and 12 months]

Вторичные конечные точки (2)

• Keratinized tissue width [Срок оценки: at baseline 3,6 and 12 months]
• Root coverage esthetic score (RES) [Срок оценки: at baseline 3,6 and 12 months]

Критерии участия

Критерии включения

• Medically free patients (American Society of Anesthesiologists I; ASA I)
• Patients diagnosed with recession (RT1)
• Fair oral hygiene
• Patient accepting to provides an informed consent and the follow-up

Критерии исключения

• Carious teeth and teeth with periapical infection.
• Patients diagnosed with periodontitis
• Smokers
• Pregnant and lactating females

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of oral and dental medicine, Misr international university — Cairo

Идентификаторы

NCT: NCT05688293 · PER 5213005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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