Management of Postoperative Pain Following Free Gingival Graft Harvesting Using Ora-Aid Versus Acrylic Palatal Stent
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: Ora-Aid Oral Wound Dressing, Acrylic Resin Palatal Stent.
- Кому может быть актуально
- Состояния в реестре: Postoperative Pain, Mucogingival Defects, Gingival Recessions. Базовые параметры: от 18 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Clinical Effectiveness of Oral Wound Dressing (Ora-Aid) in Comparison to Palatal Stent in Management of Postoperative Pain Following Free Gingival Graft Harvesting: A Randomized Clinical Trial.
Обзор
This randomized clinical trial evaluates the effectiveness of Ora-Aid oral wound dressing compared to an acrylic palatal stent in managing postoperative pain following free gingival graft harvesting. Patients undergoing graft harvesting will be randomly assigned to receive either Ora-Aid dressing or a palatal stent at the donor site. The primary outcome is postoperative pain assessed using the Visual Analogue Scale (VAS). Secondary outcomes include analgesic consumption, wound size, patient satisfaction, and color match over a 42-day follow-up period.
Подробное описание
Free gingival graft (FGG) harvesting is a commonly used periodontal procedure, but it is associated with significant postoperative pain and discomfort at the palatal donor site. Traditional management using acrylic palatal stents provides mechanical protection but may interfere with patient comfort and oral function.
Ora-Aid is a bio-adhesive hydrogel-based wound dressing designed for intraoral use, providing protection, reducing mechanical irritation, and potentially enhancing healing. Despite promising results in previous studies, there is limited evidence from randomized controlled trials comparing Ora-Aid with conventional palatal stents.
This study is a randomized, parallel-group clinical trial designed to compare the effectiveness of Ora-Aid and acrylic palatal stents in managing postoperative pain following FGG harvesting. Patients will be randomly allocated in a 1:1 ratio to either intervention group.
Pain will be assessed using the Visual Analogue Scale (VAS), while secondary outcomes include analgesic consumption, wound size, patient satisfaction, and color match at multiple postoperative time points (3, 7, 14, 21, and 42 days).
Вмешательства
- Другое Ora-Aid Oral Wound Dressing
Ora-Aid is a hydrogel-based, bioadhesive wound dressing designed for intraoral application. After harvesting the free gingival graft and managing hemostasis at the palatal donor site, the Ora-Aid patch will be cut and adjusted to fit the wound size. The dressing will be applied directly to the palatal wound and pressed gently for 10 seconds to aid adherence. It will then be fixed using 5/0 proline suture with a slinged horizontal figure-eight suture technique. The dressing provides a physical ba - Устройство Acrylic Resin Palatal Stent
A custom-made acrylic resin palatal stent is fabricated from an alginate impression and applied to the palatal donor site immediately after free gingival graft harvesting. The stent provides mechanical protection, stabilizes the blood clot, and reduces postoperative trauma. It is retained in place for approximately 2 weeks, with periodic removal for clinical evaluation of wound healing.
Первичные конечные точки
- Postoperative Pain [Срок оценки: Days 1, 2, 3, 4, 5, 6, and 7 postoperatively]
Вторичные конечные точки (4)
- Analgesic Consumption [Срок оценки: Daily for 7 days postoperatively]
- Wound Size [Срок оценки: Day 0 (surgery day), Day 3, Day 7, Day 14, and Day 21]
- Patient Satisfaction with Healing Process [Срок оценки: 1 week (Day 7) postoperatively]
- Color Match of Palatal Mucosa [Срок оценки: Day 3, Day 7, Day 14, Day 21, and Day 42 postoperatively]
Критерии участия
Критерии включения
- Patient over 18 years of age
- Systemically healthy
- Patients with good oral hygiene
- Patients with mucogingival defects scheduled for free gingival graft (FGG)
Критерии исключения
- Pregnancy or breastfeeding
- Severe gagging reflex
- Smokers
- Patients allergic to the materials used in the study
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
- Faculty of Dentistry, Cairo University — Cairo
Идентификаторы
NCT: NCT07523802 · PER3-3-4