Free Gingival GraftNCT07019428
Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique
A study testing Free gingival graft stabilized by Titanium fixation tacs and Free gingival graft stabilized by sutures in people with Free Gingival Graft and Soft Tissue Augmentation Around Dental Implants, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this randomized, controlled, parallel-grouped, clinical trial is to evaluate the width of keratinized gingiva after free gingival graft stabilized by titanium fixation tacs compared to traditional suturing. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Free Gingival Graft, Soft Tissue Augmentation Around Dental Implants, Inadequate Keratinized Tissue Around Dental Implants
- What is being tested?
- Free gingival graft stabilized by Titanium fixation tacs and Free gingival graft stabilized by sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2024to 1 Feb 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy individuals of age ≥ 18 to 40 years with absence of active periodontal disease.
- Having inadequate width of keratinized gingiva (< 2 mm).
- No systemic disease according to Modified Cornell Medical Index health questionnaire
- Non-smoker.
- Full mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
- No malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth.
- No blood-borne conditions.
Who cannot join
- Active orthodontic treatment.
- Previous periodontal surgery.
- Systemic disease.
- Use of blood thinners.
- Use of any drugs that might lead to gingival enlargement.
- Mucogingival stress, bruxism.
- Pregnancy or lactation.
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
Faculty of Dentistry, Cairo University
Cairo, 11511
About this study
Official title: Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique: A Randomized Controlled Clinical Trial
The aim of this randomized, controlled, parallel-grouped, clinical trial is to evaluate the width of keratinized gingiva after free gingival graft stabilized by titanium fixation tacs compared to traditional suturing.
Research question:
In patients with inadequate keratinized gingiva undergoing soft tissue augmentation by free gingival graft , will graft stabilization using Titanium fixation tacs affect the amount of keratinized tissue gain compared to graft stabilization using sutures ?
Read the detailed description
Free gingival graft obtained from the palate, usually replaces missing or lost keratinized tissue. Although it represents the gold standard, its success relies on providing intimate and atraumatic stabilization, as maintaining the plasmatic circulation is crucial for graft healing and perfusion, considering that judging the success of free gingival graftis based on the extent of the postoperative healing contraction and the quality of graft adherence to the underlying periosteum.
Suturing can be time consuming and sometimes fail to achieve a positive result. Also it was reported that for every one-minute increase of the gingival augmentation procedure time, there is a 4% likely increase for pain and a 3% for swelling.
However, by using fixation tacs the surgical time can be significantly reduced and the procedure can be less technique sensitive.
- Conditions
- Free Gingival Graft, Soft Tissue Augmentation Around Dental Implants, Inadequate Keratinized Tissue Around Dental Implants
- Being tested
- Free gingival graft stabilized by Titanium fixation tacs, Free gingival graft stabilized by sutures
- Keywords
- Free gingival graft, Titanium tacks, Keratinized tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graft stabilized by Titanium fixation tacsProcedure or surgery
Free gingival graft stabilized by Titanium fixation tacs , in patients with inadequate keratinized gingiva
Free gingival graft stabilized by suturesProcedure or surgery
Free gingival graft stabilized by sutures , in patients with inadequate keratinized gingiva
| Study group | Role | What they receive |
|---|---|---|
| Free gingival graft stabilized by sutures | Active comparator | Not described Receives: Procedure: Free gingival graft stabilized by sutures |
| Free gingival graft stabilized by by Titanium fixation tacs | Experimental | Not described Receives: Procedure: Free gingival graft stabilized by Titanium fixation tacs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of keratinized gingiva
Measured: 6-month
Secondary outcomes (1)
Surgery time
time spent from the beginning to the end of surgery
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start2 Nov 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Gingival GraftStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Atef Kamal Ibrahim, Cairo University
- Investigators
- Amr Zahran, Professor of Periodontology, Principal investigator, Cairo UniversityManar El Zanaty, lecturer of Periodontology, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019428
- Sponsor's protocol ID
- TacFGG
- Status last verified
- May 2025
- First submitted
- 2 Jan 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07019428
- Acronym / sponsor ID
- TacFGG
- Conditions
- Free Gingival Graft, Soft Tissue Augmentation Around Dental Implants, Inadequate Keratinized Tissue Around Dental Implants
- Keywords
- Free gingival graft, Titanium tacks, Keratinized tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 13 Jun 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 aim of this randomized, controlled, parallel-grouped, clinical trial is to evaluate the width of keratinized gingiva after free gingival graft stabilized by titanium fixation tacs compared to traditional suturing.
Research question:
In patients with inadequate keratinized gingiva undergoing soft tissue augmentation by free gingival graft , will graft stabilization using Titanium fixation tacs affect the amount of keratinized tissue gain compared to graft stabilization using sutures ?
Detailed description
Free gingival graft obtained from the palate, usually replaces missing or lost keratinized tissue. Although it represents the gold standard, its success relies on providing intimate and atraumatic stabilization, as maintaining the plasmatic circulation is crucial for graft healing and perfusion, considering that judging the success of free gingival graftis based on the extent of the postoperative healing contraction and the quality of graft adherence to the underlying periosteum.
Suturing can be time consuming and sometimes fail to achieve a positive result. Also it was reported that for every one-minute increase of the gingival augmentation procedure time, there is a 4% likely increase for pain and a 3% for swelling.
However, by using fixation tacs the surgical time can be significantly reduced and the procedure can be less technique sensitive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free gingival graft stabilized by sutures | Active comparator | Procedure: Free gingival graft stabilized by sutures |
| Free gingival graft stabilized by by Titanium fixation tacs | Experimental | Procedure: Free gingival graft stabilized by Titanium fixation tacs |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Systemically healthy individuals of age ≥ 18 to 40 years with absence of active periodontal disease.
- Having inadequate width of keratinized gingiva (< 2 mm).
- No systemic disease according to Modified Cornell Medical Index health questionnaire
- Non-smoker.
- Full mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
Key exclusion criteria (7 listed)
- Active orthodontic treatment.
- Previous periodontal surgery.
- Systemic disease.
- Use of blood thinners.
- Use of any drugs that might lead to gingival enlargement.
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 |
|---|---|---|
| Free gingival graft stabilized by Titanium fixation tacsFree gingival graft stabilized by Titanium fixation tacs , in patients with inadequate keratinized gingiva | Procedure or surgery | Free gingival graft stabilized by by Titanium fixation tacs |
| Free gingival graft stabilized by suturesFree gingival graft stabilized by sutures , in patients with inadequate keratinized gingiva | Procedure or surgery | Free gingival graft stabilized by sutures |
Primary outcome
Width of keratinized gingiva
Time frame: 6-month
1 secondary outcome
Surgery time
Time frame: Perioperative
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 13 Jun 2025.
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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.
Amr Zahran, Professor of Periodontology principal investigator
Cairo University
Manar El Zanaty, lecturer of Periodontology principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free gingival graft stabilized by Titanium fixation tacs and Free gingival graft stabilized by sutures in people with Free Gingival Graft and Soft Tissue Augmentation Around Dental Implants, run by Cairo University 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 7 inclusion and 7 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 13 Jun 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 Mohamed Atef Kamal Ibrahim, Bds (+2001121266030, mohamed-kamal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Width of keratinized gingiva (time frame: 6-month). 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 13 Jun 2025.