CTG Versus Collagen Matrix for Peri-Implant Soft Tissue Augmentation
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: Collagen Matrix, Connective Tissue Graft.
- Кому может быть актуально
- Состояния в реестре: Peri-implant Soft Tissue Deficiency, Insufficient Peri-implant Keratinized Tissue. Базовые параметры: 18 лет — 65 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
- Вьетнам
- 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
Results of Soft Tissue Grafting Around Implant in the Mandible Molar Area
Обзор
This randomized controlled trial compares two techniques for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients requiring implant treatment with insufficient peri-implant soft tissue thickness will be randomly assigned to receive either CTG or a collagen matrix at the time of implant surgery. The study aims to evaluate and compare changes in peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour over a 9-month follow-up period, as well as the occurrence of postoperative complications. The results of this study will help determine whether a collagen matrix can provide clinical outcomes comparable to those of connective tissue grafting for peri-implant soft tissue augmentation.
Подробное описание
This randomized controlled trial is designed to compare two approaches for peri-implant soft tissue augmentation in the mandibular molar region: an autogenous connective tissue graft (CTG) and a collagen matrix. Adult patients with insufficient peri-implant soft tissue thickness will be enrolled and randomly allocated in a 1:1 ratio to receive either CTG or a collagen matrix at the time of implant surgery. Randomization will be performed using a block randomization method, and outcome assessment will be conducted by a blinded examiner.
Clinical and digital evaluations will be performed at predefined time points, including baseline and follow-up visits up to 9 months after surgery. Peri-implant soft tissue thickness, width of keratinized tissue, and soft tissue contour changes will be assessed using standardized clinical measurements and digital workflows based on intraoral scanning and cone-beam computed tomography where indicated. Postoperative healing and adverse events will be monitored throughout the follow-up period.
The study is conducted at a single academic center and is intended to provide comparative clinical data on the effectiveness and safety of collagen matrix versus connective tissue grafting for peri-implant soft tissue augmentation.
Вмешательства
- Устройство Collagen Matrix
A porcine-derived collagen matrix is used for peri-implant soft tissue augmentation at the time of implant surgery, serving as a substitute for autogenous connective tissue grafting. - Процедура Connective Tissue Graft
An autogenous connective tissue graft harvested from the patient is used for peri-implant soft tissue augmentation at the time of implant surgery.
Первичные конечные точки
- Change in peri-implant soft tissue thickness [Срок оценки: Baseline (before surgery) to 9 months after surgery]
Вторичные конечные точки (3)
- Change in width of peri-implant keratinized tissue [Срок оценки: Baseline to 9 months after surgery]
- Change in peri-implant marginal bone level [Срок оценки: Baseline to 9 months after surgery]
- Peri-implant clinical indices [Срок оценки: Up to 9 months after surgery]
Критерии участия
Критерии включения
Adults aged 18 to 65 years.
Patients requiring dental implant treatment in the mandibular molar region.
Presence of insufficient peri-implant soft tissue thickness (< 2 mm).
Adequate general health to undergo minor oral surgery.
Ability and willingness to provide written informed consent and comply with study procedures.
Критерии исключения
Systemic conditions or medications that may impair wound healing.
Heavy smoking (more than 10 cigarettes per day).
History of allergy or hypersensitivity to collagen-based materials.
Previous graft failure or complications at the intended implant site.
Loss of three or more adjacent teeth in the study area (excluding third molars).
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
Вьетнам · 1 центр
- Hanoi Medical University — Hanoi
Идентификаторы
NCT: NCT07371481 · 01250159