Evaluation of Post-operative Pain After Stabilization of Free Gingival Graft for Keratinized Tissue Augmentation Around Natural Teeth Using Titanium Tacks Versus Standard Suturing Technique.
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: Free gingival grafting (FGG) using titanium tacks for stabilization, Free gingival grafting (FGG) using sutures for stabilization..
- Кому может быть актуально
- Состояния в реестре: To Clinically Compare Post-operative Pain Between Free Gingival Grafts Stabilization Around Natural Teeth Using Titanium Tacks vs Suturing Technique. 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 Evaluation of Titanium Tacks Used for the Stabilization of Free Gingival Graft in Gingival Augmentation Around Natural Teeth: A Randomized Controlled Clinical Trial
Обзор
The goal of this clinical trial is to learn whether titanium tacks can be used as an alternative to sutures for stabilization of free gingival grafts (FGG) around natural teeth. It will also evaluate the effect of each stabilization technique on patient comfort and clinical outcomes. The main questions it aims to answer are: * Does stabilization of free gingival grafts using titanium tacks reduce post-operative pain compared with conventional suturing? * Does stabilization of free gingival grafts using titanium tacks affect clinical outcomes such as keratinized tissue width, gingival thickness, graft dimensions, procedure time, plaque accumulation, and interference with daily activities? Researchers will compare free gingival graft stabilization using titanium tacks with the conventional suturing technique to determine whether titanium tacks provide comparable or improved outcomes. Participants will: * Receive a free gingival graft around natural teeth requiring augmentation of keratinized gingival tissue. * Be assigned to have the graft stabilized either with titanium tacks or with conventional resorbable sutures. * Attend scheduled follow-up visits for clinical examinations and measurements. * Report their post-operative pain levels using a Visual Analogue Scale (VAS). * Complete assessments related to daily life interference during the healing period. * Undergo evaluation of keratinized tissue width, gingival thickness, graft dimensions, plaque index, and procedure time.
Вмешательства
- Процедура Free gingival grafting (FGG) using titanium tacks for stabilization
According to the graft size, 2 to 5 titanium tacks will be used to stabilize and secure the free gingival graft in place to the periosteum at the recipient bed as needed, through anchoring in inter-septal bone and avoiding teeth roots. - Процедура Free gingival grafting (FGG) using sutures for stabilization.
Stabilization of the free gingival autograft in place using a 5-0 or 6-0 resorbable Prolene suture using a combination of two interrupted sutures, anchoring the grafted tissue to the base of the anatomical papillae, and a horizontal mattress compression suture anchored to the periosteum apical to the bone dehiscence and suspended around the palatal or lingual cingulum of the tooth with the recession defect, allowing for intimate contact ensuring proper perfusion and consequent revascularization
Первичные конечные точки
- Postoperative pain [Срок оценки: Daily for the first 7 days post-surgery.]
Вторичные конечные точки (7)
- Keratinized tissue width (KTW) [Срок оценки: Week 12, Week 24]
- Intra-operative/procedure time (PT) [Срок оценки: During the free gingival graft stabilization procedure]
- Daily life interference [Срок оценки: Daily for the first 7 days post-surgery.]
- Gingival thickness [Срок оценки: Week 12, Weeks 24.]
- Post-operative Pain [Indirect] [Срок оценки: Daily for the first 7 days post-surgery.]
- Plaque Index [Срок оценки: Week 12, Week 24.]
- Graft dimensions [Срок оценки: Week 12, Week 24.]
Критерии участия
Критерии включения
- Patients age 18 years or older.
- Patients with healthy systemic condition.
- Indication for FGG treatment (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession) around natural teeth.
- Keratinized tissue width (KTW) < 2 mm.
- Good oral hygiene.
- Cooperative patients.
Критерии исключения
- Pregnant females.
- Smokers: a contraindication for any plastic periodontal surgery.
- Unmotivated and uncooperative patients with poor oral hygiene.
- Patients with habits that may compromise the longevity and affect the result of the study as parafunctional habits.
- Patients who have undergone periodontal surgery in the same area within 6 months.
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 and Oral Medicine, Cairo University, Cairo. — Cairo
Идентификаторы
NCT: NCT07655349 · 28/1/2025