Deficient Keratinized MucosaNs-dFGG; cFGGNCT07174752
Non-Submerged De-Epithelialized Free Gingival Graft Versus Conventional Free Gingival Graft
A study testing Non-Submerged De-Epithelialized Free Gingival Graft and Conventional FGG in people with Deficient Keratinized Mucosa, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deficient Keratinized Mucosa
- What is being tested?
- Non-Submerged De-Epithelialized Free Gingival Graft and Conventional FGG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Dec 2024to 29 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients: 18-60.
- Insufficient width of keratinized mucosa, that is less than 2 mm.
- Lower anterior areas.
- Good oral hygiene.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
October University for modern sciences and arts (MSA University)
Giza, 11563
Dalia Khorshed principal investigator, +201097486667, khorsheddalia12@gmail.com
Ahmed Reda Abdel Rahman, Professor, +201206960001, arrahman@msa.edu.eg
About this study
Official title: 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
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
- Being tested
- Non-Submerged De-Epithelialized Free Gingival Graft, Conventional FGG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Submerged De-Epithelialized Free Gingival GraftProcedure or surgery
The Free gingival graft will be de-epithelialized and fixed at the recipient site in a non-submerged manner to increase the keratinized mucosa
Conventional FGGProcedure or surgery
The Free gingival graft will be fixed at the recipient site to increase the keratinized mucosa
| Study group | Role | What they receive |
|---|---|---|
| Ns-dFGG | Active comparator | This arm will receive a Non-Submerged De-Epithelialized Free Gingival Graft for for the Augmentation of The Keratinized Mucosa Receives: 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 Receives: Procedure: Conventional FGG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start29 Dec 2024
- Primary completion29 Jul 2026 (estimated)
- Study completion29 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficient Keratinized MucosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Khorshed, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174752
- Sponsor's protocol ID
- 61124
- Other IDs
- Ethical committee
- Acronym
- Ns-dFGG; cFGG
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: collective data of the study groups will be available
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07174752
- Acronym / sponsor ID
- Ns-dFGG; cFGG / 61124
- Conditions
- Deficient Keratinized Mucosa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 29 Dec 2024 (actual)
- Primary completion
- 29 Jul 2026 (estimated)
- Study completion
- 29 Dec 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ns-dFGG | Active comparator | Procedure: Non-Submerged De-Epithelialized Free Gingival GraftThis arm will receive a Non-Submerged De-Epithelialized Free Gingival Graft for for the Augmentation of The Keratinized Mucosa |
| FGG | Active comparator | Procedure: Conventional FGGThis arm will receive a Conventional Free Gingival Graft for for the Augmentation of The Keratinized Mucosa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients: 18-60.
- Insufficient width of keratinized mucosa, that is less than 2 mm.
- Lower anterior areas.
- Good oral hygiene.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Submerged De-Epithelialized Free Gingival GraftThe Free gingival graft will be de-epithelialized and fixed at the recipient site in a non-submerged manner to increase the keratinized mucosa | Procedure or surgery | Ns-dFGG |
| Conventional FGGThe Free gingival graft will be fixed at the recipient site to increase the keratinized mucosa | Procedure or surgery | FGG |
Primary outcome
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
Time frame: 6 months
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
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
Time frame: 6 months
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No. collective data of the study groups will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Submerged De-Epithelialized Free Gingival Graft and Conventional FGG in people with Deficient Keratinized Mucosa, run by October University for Modern Sciences and Arts at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia Khorshed, Masters candidate (+201097486667, khorsheddalia12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.