Efficacy of Collagen Sponge on Palatal Wound Healing

Официальное название

Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial

Обзор

The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting.

Подробное описание

The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting. The included patients will be randomized into two groups. The patients in control group will be treated with gelatin sponge and those in the test group will be treated with collagen sponge. The postoperative pain will be assessed by VAS scale at day 1, 3 and 7 after surgery. Epithelialization of the palatal wound will be evaluated by hydrogen peroxide test and digital photography at 1 week postoperatively. Additionally, postoperative pain, consumption of analgesics, willingness to repeat the treatment and the existence of delayed bleeding will be recorded at 1 week. At 2 weeks, 3 weeks and 1 month after surgery, epithelialization of the palatal wound and aesthetic scores will be evaluated.

Вмешательства

• Процедура Palatal soft tissue graft harvesting
  After local anaesthesia, a horizontal incision 2 mm apically from the gingival margin will be carried out using a #15C blade. The standardized rectangular graft with a thickness of 1.5 mm will be harvested from distal aspect of canine till first molar. The graft will be lifted and separated using tissue forceps and a blade till it is free from all sides.

Первичные конечные точки

• epithelialization of the palatal wound evaluated by hydrogen peroxide test [Срок оценки: at 1 week]
• epithelialization of the palatal wound evaluated by hydrogen peroxide test [Срок оценки: at 2 weeks]
• epithelialization of the palatal wound evaluated by hydrogen peroxide test [Срок оценки: at 3 weeks]
• epithelialization of the palatal wound evaluated by hydrogen peroxide test [Срок оценки: at 1 month]
• epithelialization of the palatal wound evaluated by digital photography [Срок оценки: at 1 week]
• epithelialization of the palatal wound evaluated by digital photography [Срок оценки: at 2 weeks]
• epithelialization of the palatal wound evaluated by digital photography [Срок оценки: at 3 weeks]
• epithelialization of the palatal wound evaluated by digital photography [Срок оценки: at 1 month]

Вторичные конечные точки (8)

• postoperative pain [Срок оценки: at day 1]
• postoperative pain [Срок оценки: at day 3]
• postoperative pain [Срок оценки: at day 7]
• consumption of analgesics [Срок оценки: at 1 week]
• willingness to repeat the treatment [Срок оценки: at 1 week]
• the existence of delayed bleeding [Срок оценки: at 1 week]
• aesthetic score [Срок оценки: at 3 weeks]
• aesthetic score [Срок оценки: at 1 month]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Clinical indications utilizing free gingival grafts or de-epithelialized gingival grafts to treat either insufficient keratinized tissue or gingival recession defects
• Full-mouth plaque score and full-mouth bleeding score lower than 20%

Критерии исключения

• Smoking
• Pregnancy or lactation
• Untreated periodontal disease
• Severe systemic conditions that contraindicate surgery (diabetes, heart disease, cancer etc.)
• Presence of coagulation disorders (history of Haemophilia, von Wille-brand disease, or anticoagulant therapy)
• Taking medications affecting periodontal health or healing
• Previous surgery for a palate graft harvested from the experimental sites

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

Китай · 1 центр

• The Affiliated Stomatology Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT05287763 · DHZhejiangU-2022(024)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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