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Активно (без набиране) Не е приложимо NCT07346391

Augmentation of Peri-implant Keratinized Mucosa Using a Combination of Free Gingival Graft Strip With Platelet-Rich Fibrin

Не е приложима фаза (напр. обсервационно)
Заболявания: Dental Implants

Спонсор: Nguyen Van Khuong

Налично на: БГ
Обобщение
This clinical trial aims to evaluate the clinical effectiveness of combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) for increasing keratinized mucosa around dental implants. The study compares this combined technique with the conventional free gingival graft (FGG) method through three primary objectives: 1. comparing the increase in keratinized mucosal height at immediate post-op, 1, 3, and 6 months; 2. assessing post-operative pain levels at 1, 3, 7, and 14 days; 3. evaluating soft tissue aesthetic outcomes at 4 and 6 months post-surgery.
Описание
Pre-operative phase: Eligible patients undergo clinical examination and medical record documentation. Written informed consent is obtained prior to enrollment. Participants are randomly assigned by drawing one of 22 sealed envelopes: odd numbers are allocated to Group A (strip free gingival graft with PRF) and even numbers to Group B (conventional free gingival graft). Baseline intraoral and extraoral photographs and intraoral scans (PLY format) are obtained. Intra-operative phase: * Group A (Experimental): PRF is prepared from venous blood. A strip free gingival graft is harvested from the palate and placed at the recipient site in combination with PRF. * Group B (Control): A conventional free gingival graft is harvested from the palate and placed at the recipient site. Post-operative phase: Follow-up visits are conducted at days 1, 3, 7, and 14, and at 1, 3, and 6 months post-surgery. At 1 month, healing abutments are placed and prosthetic treatment begins. Keratinized mucosa changes are assessed using pre- and post-operative intraoral scans. Post-operative pain is evaluated using the Visual Analog Scale (VAS), and soft tissue aesthetic outcomes are assessed at 3 and 6 months using a standardized aesthetic score.
Кой може да участва
Inclusion Criteria: * Patients meeting the following criteria are eligible for the study: * Prosthetic Phase: Patients scheduled for the prosthetic phase of dental implant treatment. * Keratinized Mucosa: Keratinized mucosa height (buccal or lingual) of less than 2 mm around the implant. * Systemic Health: Systemic health status classified as ASA I or II according to the American Society of Anesthesiologists classification. * Oral Hygiene: Good oral hygiene, defined by a mean full-mouth plaque index (PlI) of ≤ 1. Exclusion Criteria: * Patients meeting any of the following criteria will be excluded from the study: * Systemic Conditions: Presence of systemic diseases or use of medications known to affect the oral mucosa or gingival health. * Periodontal Health: Untreated periodontal disease and/or peri-implant diseases. * Surgical History: History of mucogingival surgery at the intended surgical site. * Pregnancy/Lactation: Pregnant or breastfeeding women. * Oral Hygiene: Poor oral hygiene, defined by a mean full-mouth plaque index (PlI) \> 1. * Smoking: Current smokers.
Интервенции
Combining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implants
PROCEDURE
Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implants
PROCEDURE
Места на провеждане 1
Vietnam (1)
Phòng Khám Chuyên Khoa Răng Hàm Mặt Đại Học Y Dược Thành Phố Hồ Chí Minh
HỒ CHÍ MINH , VIỆT NAM
Технически детайли
Статус
Активно (без набиране)
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Здрави доброволци
Не
Начална дата
24.12.2025
Крайна дата
01.07.2026
Регистрационен номер
NCT07346391
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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