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

NCT07346391 | Active Not Recruiting

• 1 other identifier: 25309-DHYD
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 1.comparing the increase in keratinized mucosal height at immediate post-op, 1, 3, and 6 months;
2. 2.assessing post-operative pain levels at 1, 3, 7, and 14 days;
3. 3.evaluating soft tissue aesthetic outcomes at 4 and 6 months post-surgery.

Conditions

Dental Implants

Keywords

Combination technique of strip free gingival grafts and PRF in augmenting keratinized mucosa around dental implants

Outcome Measures

Primary Outcomes (3)

• Assessment of the increase in peri-implant keratinized mucosa width

  KMW was assessed at the mid-buccal aspect of each implant, measuring the distance from the MGJ to the mucosal margin/alveolar zenith using STL surface data at 1, 3, and 6 months.

  1, 3, 6 months

• Soft tissue esthetics assessed by the modified Pink Esthetic Score (PES)

  "The esthetic outcome of the peri-implant soft tissue is evaluated using the modified Pink Esthetic Score (PES) as described by Fürhauser et al. (2005). The assessment compares the grafted area to the adjacent natural tooth based on seven parameters: Soft tissue color difference, soft tissue texture difference, grafted site margins-mesial side, distal side, level of mucogingival junction, keloid-like appearance. Each parameter is assigned a score of 0, 1, or 2 (0 being the lowest, 2 being the highest/most esthetic). The total PES score ranges from 0 to 14, where a higher score indicates a superior esthetic result

  4 months and 6 months post-operatively

• Post-operative pain intensity measured by Visual Analog Scale (VAS)

  Pain intensity is measured on a Visual Analog Scale from 0 (no pain) to 10 (unbearable pain). Participants will be asked to mark their level of discomfort at each time point.

  1, 3, 7 and 14 days post-operatively

Study Arms (2)

Conventional Free Gingival Graft (FGG)

EXPERIMENTAL

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 mucosa

Procedure: Conventional Free Gingival Graft (FGG) to increase keratinized mucosa around dental implants

Combining a strip free gingival graft with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa

EXPERIMENTAL

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.

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

Interventions

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

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.

Combining a strip free gingival graft with Platelet-Rich Fibrin (PRF) to increase keratinized mucosa

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

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

Conventional Free Gingival Graft (FGG)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nguyen Van Khuong: lead

Study Sites (1)

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

HỒ CHÍ MINH, VIỆT NAM, 123456789, Vietnam

Location

MeSH Terms

Interventions

Prolactin-Releasing Hormone; fibrinopeptides gamma

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The soft tissue aesthetic outcomes are evaluated by an independent assessor who is blinded to the treatment groups (the assessor does not know which group the patient being evaluated belongs to).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 16, 2026
• Study Start: December 24, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

VN (1)