Evaluation of De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts

Официальное название

A Randomized Controlled Trial to Compare De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts

Обзор

This study aims to compare the de-epithelized gingival graft (control group) and modified combined approach for connective tissue graft (test group) in patients undergoing palatal graft harvesting for mucogingival surgery in the oral cavity

Подробное описание

Harvesting a palatal mucosal tissue graft as an autologous donor for oral soft tissue augmentation is widely practiced. Tissue harvest in patients with anatomically thin phenotypes can cause significant morbidity and compromised healing process. The modified combined approach (MCA) for connective tissue grafts has the potential for faster healing and fewer postoperative complications, compared to the recommended harvesting technique of de-epithelized gingival graft (DGG). However, the modified combined approach for connective tissue grafts have yet to be extensively investigated.

This examiner-masked, randomized study aims to compare post-operative morbidity and treatment outcomes in patients undergoing modified combined approach for connective tissue graft (test group) compared to the de-epithelized gingival graft (control group) harvesting techniques in tissue augmentation.

Participants will be randomized into two groups receiving one of either modified combined approach for connective tissue graft or de-epithelized gingival graft. Collection of the study parameters will utilize both examiner-assessed, and patient reported outcomes.

The study will report on the optimum palatal mucosal graft harvesting technique in an Asian population. The findings of this study will be utilized to formulate clinical recommendations for soft tissues augmentation in this population.

Вмешательства

• Процедура modified combined approach
  A thin layer of epithelium will be excised from the harvested graft. This epithelium will be replaced at the donor site and sutured.
• Процедура de-epithelized gingival graft
  Only dressing material will be placed at the donor site after graft harvesting

Первичные конечные точки

• Pain after gingival graft harvesting [Срок оценки: up to 3 months after surgery]

Вторичные конечные точки (1)

• Healing after gingival graft harvesting [Срок оценки: up to 3 months after surgery]

Критерии участия

Критерии включения

• systemically healthy subjects;
• able to give informed consent;
• age ≥ 18 years;
• requiring palatal tissue harvesting for soft tissue augmentation in the oral cavity

Критерии исключения

• subjects with periodontal diseases;
• subjects with poor oral hygiene of >30% plaque index;
• pregnant or lactating females;
• subjects taking medication with any known effect on the periodontal soft tissues;
• subjects with pathology in the oral cavity causing any degree of pain;
• subjects wearing removable or fixed prothesis that is in contact with the donor site an
• those with allergies to painkillers including ibuprofen and paracetamol.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Faculty of Dentistry — Kuala Lumpur

Идентификаторы

NCT: NCT05717985 · GGPM-2022-024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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