RecruitingNot ApplicableNCT07346391

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

Clinical Effectiveness of Combining Free Gingival Strip Graft With Platelet-Rich Fibrin for Peri-Implant Keratinized Mucosa Augmentation


Sponsor

Nguyen Van Khuong

Enrollment

22 participants

Start Date

Dec 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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, 4, 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.


Eligibility

Inclusion Criteria5

  • 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 Criteria7

  • 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.

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Interventions

PROCEDURECombining a strip free gingival graft (sFGG) with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa around dental implants

Venous blood is collected using a butterfly needle and 10ml tubes to prepare the PRF membrane. A keratinized mucosa strip of appropriate dimensions is harvested from the patient's palate. The strip free gingival graft and PRF membrane are then sutured and stabilized at the recipient site.

PROCEDUREConventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implants

A surgical procedure where a graft consisting of epithelium and connective tissue is harvested from the palate and transplanted to the peri-implant area to increase the width and height of keratinized


Locations(1)

Phòng Khám Chuyên Khoa Răng Hàm Mặt Đại Học Y Dược Thành Phố Hồ Chí Minh

HỒ CHÍ MINH, VIỆT NAM, Vietnam

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NCT07346391


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