Non-Submerged De-Epithelialized Free Gingival Graft Versus Conventional Free Gingival Graft

NCT07174752 | Recruiting

• 2 other identifiers: 61124Ethical committee
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this (study type: RCT) is to learn if the use of the non-submerged de-epithelized FGG will result in better esthetic outcomes in adults. The main questions that it aims to answer are:

• Does this procedure increase the width of keratinized tissue?
• Does this procedure increase the depth of the vestibule? Researchers will compare this technique with the gold standard using the FGG to evaluate which technique provides better esthetics.

Conditions

Deficient Keratinized Mucosa

Outcome Measures

Primary Outcomes (2)

• Esthetic Evaluation of Non-Submerged De-Epithelialized Free Gingival Graft (Ns-dFGG) Versus Conventional Free Gingival Graft (cFGG) for the Augmentation of The Keratinized Mucosa

  The professional esthetic evaluation will be done using the root coverage esthetic score (RES) by(Cairo et al.,2009). Standardized Clinical photographs will be taken at 6 months, where they will evaluate: Color matching: Score 0, \& Score 1: Regarding the color matching to the normal gingiva Soft tissue texture: Score 0, \& Score 1: If there is scar formation or keloid appearance Muco-gingival junction (MGJ) alignment: Score 0, \& Score 1:If the MGJ is or isn't aligned that of the adjacent teeth

  6 months

• Esthetic Evaluation of Non-Submerged De-Epithelialized Free Gingival Graft (Ns-dFGG) Versus Conventional Free Gingival Graft (cFGG) for the Augmentation of The Keratinized Mucosa

  The patient esthetic evaluation will evaluated at 6 months during the follow-up based on the Visual Analogue Scale(VAS). They will select among 100 scores of color matching: Score 0(Very bad) 50(Average) 100(Excellent)

  6 months

Study Arms (2)

Ns-dFGG

ACTIVE COMPARATOR

This arm will receive a Non-Submerged De-Epithelialized Free Gingival Graft for for the Augmentation of The Keratinized Mucosa

Procedure: Non-Submerged De-Epithelialized Free Gingival Graft

FGG

ACTIVE COMPARATOR

This arm will receive a Conventional Free Gingival Graft for for the Augmentation of The Keratinized Mucosa

Procedure: Conventional FGG

Interventions

Non-Submerged De-Epithelialized Free Gingival Graft PROCEDURE

The Free gingival graft will be de-epithelialized and fixed at the recipient site in a non-submerged manner to increase the keratinized mucosa

Ns-dFGG

Conventional FGG PROCEDURE

The Free gingival graft will be fixed at the recipient site to increase the keratinized mucosa

FGG

Eligibility Criteria

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

You may qualify if:

• Adult patients: 18-60.
• Insufficient width of keratinized mucosa, that is less than 2 mm.
• Lower anterior areas.
• Good oral hygiene.

You may not qualify if:

• Systemic conditions that prevent the patient from undergoing minor oral surgical procedures or hinder the healing process.
• Patient undertaking radiotherapy or chemotherapy.
• Smokers.
• Pregnant females

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead

Study Sites (1)

October University for modern sciences and arts (MSA University)

Giza, 11563, Egypt

RECRUITING

Central Study Contacts

Dalia Khorshed, Masters candidate

CONTACT

+201097486667; khorsheddalia12@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters candidate

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 16, 2025
• Study Start: December 29, 2024
• Primary Completion (Estimated): July 29, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)