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Active (not recruiting) Not applicable NCT07346391

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

No applicable phase (e.g. observational)
Conditions: Dental Implants

Sponsor: Nguyen Van Khuong

trial.available_in: БГ
Overview
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.
Description
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.
Who can participate
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.
Interventions
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
Locations 1
Vietnam (1)
Phòng Khám Chuyên Khoa Răng Hàm Mặt Đại Học Y Dược Thành Phố Hồ Chí Minh
HỒ CHÍ MINH , VIỆT NAM
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Healthy volunteers
No
Start date
24.12.2025
Completion date
01.07.2026
Registry ID
NCT07346391
Source
clinicaltrials.gov
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