Non-submerged de-epithelialized free gingival graft compared with conventional free gingival graft
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: Randomized Controlled Clinical Trial
NA · October University for Modern Sciences and Arts · NCT07174752
This trial will see if a non-submerged de-epithelialized free gingival graft gives better esthetic results and increases keratinized tissue width and vestibular depth in adults with less than 2 mm of keratinized mucosa.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | October University for Modern Sciences and Arts (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Giza) |
| Trial ID | NCT07174752 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares a non-submerged de-epithelialized free gingival graft technique with the conventional free gingival graft in adults. Participants aged 18–60 with <2 mm keratinized mucosa in the lower anterior region and good oral hygiene will be randomized to one of the two surgical approaches. Key outcomes include change in keratinized tissue width, vestibular depth, and esthetic appearance measured over the post-operative follow-up period. Patients with systemic conditions affecting healing, smokers, those receiving radiotherapy/chemotherapy, and pregnant women are excluded.
Who should consider this trial
Good fit: Adults 18–60 with insufficient keratinized mucosa (<2 mm) in the lower anterior area, good oral hygiene, and no contraindicating systemic conditions are ideal candidates.
Not a fit: Patients who smoke, have systemic conditions that impair healing, are receiving radiotherapy/chemotherapy, are pregnant, or already have adequate keratinized mucosa are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, the non-submerged de-epithelialized technique could improve gum esthetics and increase keratinized tissue and vestibular depth compared with the conventional approach.
How similar studies have performed: Conventional free gingival grafting is an established gold standard, while de-epithelialized and non-submerged variants have shown promising but limited and variable evidence in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients: 18-60. * Insufficient width of keratinized mucosa, that is less than 2 mm. * Lower anterior areas. * Good oral hygiene. Exclusion Criteria: * 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
Where this trial is running
Giza
- October University for modern sciences and arts (MSA University) — Giza, Egypt (RECRUITING)
Study contacts
- Study coordinator: Dalia Khorshed, Masters candidate
- Email: khorsheddalia12@gmail.com
- Phone: +201097486667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Deficient Keratinized Mucosa