Lack of Keratinized TissueNCT07823374
Fixation of Free Gingival Graft Using Tissue Tacks vs Criss-cross Sutures
A study testing Criss cross sutures and Tissue tacs in people with Lack of Keratinized Tissue, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
Tissue tacks may improve graft stability but their effect on pain is unclear. The study compares tacks and sutures by measuring pain, stability, healing success, and patient comfort. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Lack of Keratinized Tissue
- What is being tested?
- Criss cross sutures and Tissue tacs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Sep 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients with inadequate keratinized tissue requiring free gingival grafts.
- Age between 18-40 years.
- Free from systemic diseases that could affect healing.
- Good oral hygiene.
- Motivated patients with a willingness to participate and comply with post-operative instructions.
Who cannot join
- Medically compromised patients
- Subjects who underwent radiotherapy or chemotherapy, pregnant women, smokers.
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
MSA university
Giza, Giza Governorate
Sherif A Doctor, Bachelor, 00201120016993, Sherif.abbas@msa.edu.eg
About this study
Official title: Assessment of Pain Score After Fixation of Free Gingival Graft Using Tissue Tacks Versus Criss- Cross Sutures in Cases With Insufficient Keratinized Tissue. A Randomized Controlled Clinical Trial.
Tissue tacks may improve graft stability but their effect on pain is unclear. The study compares tacks and sutures by measuring pain, stability, healing success, and patient comfort.
Read the detailed description
Tissue tacks are a newer method for securing free gingival grafts ,offering potential benefits such as improved graft stability and reduced movement compared to traditional criss- cross sutures. However, the impact of tissue tacks on postoperative pain remains unclear. This study seeks to evaluate whether tissue tacks, while possibly enhancing graft stability and healing, result in higher pain levels compared to sutures, and whether these outcomes affect the overall clinical success and patient comfort during healing.
- Conditions
- Lack of Keratinized Tissue
- Being tested
- Criss cross sutures, Tissue tacs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Criss cross suturesProcedure or surgery
Fixation of free gingival graft using criss cross sutures
Tissue tacsProcedure or surgery
Fixation of free gingival graft using tissue tacs
| Study group | Role | What they receive |
|---|---|---|
| criss cross sutures | Other | Fixation of free gingival graft using tissue tacs Receives: Procedure: Criss cross sutures |
| tissue tacs | Active comparator | Fixation of free gingival graft using tissue tacs Receives: Procedure: Tissue tacs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score (VAS Score)
Grade from 1-10
Measured: 1,3,5,7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Jan 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lack of Keratinized TissueStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823374
- Sponsor's protocol ID
- REC-D 6112-5
- Status last verified
- Oct 2025
- First submitted
- 12 Jan 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain Score After Fixation of Free Gingival Graft Using Tissue Tacks Versus Criss- Cross Sutures in Cases With Insufficient Keratinized Tissue. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07823374
- Acronym / sponsor ID
- REC-D 6112-5
- Conditions
- Lack of Keratinized Tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 16 Sep 2026 (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.
Tissue tacks may improve graft stability but their effect on pain is unclear. The study compares tacks and sutures by measuring pain, stability, healing success, and patient comfort.
Detailed description
Tissue tacks are a newer method for securing free gingival grafts ,offering potential benefits such as improved graft stability and reduced movement compared to traditional criss- cross sutures. However, the impact of tissue tacks on postoperative pain remains unclear. This study seeks to evaluate whether tissue tacks, while possibly enhancing graft stability and healing, result in higher pain levels compared to sutures, and whether these outcomes affect the overall clinical success and patient comfort during healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| criss cross sutures | Other | Procedure: Criss cross suturesFixation of free gingival graft using tissue tacs |
| tissue tacs | Active comparator | Procedure: Tissue tacsFixation of free gingival graft using tissue tacs |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with inadequate keratinized tissue requiring free gingival grafts.
- Age between 18-40 years.
- Free from systemic diseases that could affect healing.
- Good oral hygiene.
- Motivated patients with a willingness to participate and comply with post-operative instructions.
Key exclusion criteria (2 listed)
- Medically compromised patients
- Subjects who underwent radiotherapy or chemotherapy, pregnant women, smokers.
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 |
|---|---|---|
| Criss cross suturesFixation of free gingival graft using criss cross sutures | Procedure or surgery | criss cross sutures |
| Tissue tacsFixation of free gingival graft using tissue tacs | Procedure or surgery | tissue tacs |
Primary outcome
Pain score (VAS Score)
Time frame: 1,3,5,7 days post surgery
Grade from 1-10
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 2026.
- Individual participant dataSharing planned: Yes. All IPD
Related trials for Lack of Keratinized Tissue
Not yet recruiting
Evaluation of the Effects of Injectable Platelet-Rich Fibrin and Hyaluronic Acid Treatments, Administered in Addition to Free Gingival Graft Therapy, on Clinical Healing.
Lack of Keratinized Tissue, Mucogingival Surgery
Recruiting
Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix
Gingival Recession, Lack of Keratinized Attached Peri-implant Mucosa
Recruiting
Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT
Lack of Keratinized Gingiva, Mucogingival Deformity - Insufficient Keratinized Tissue
Active, not recruiting
A Comparison of Side Access Mucosal Releasing Incision (SAMRI) and Sulcular Tunnel Access to Treat Gingival Recession.
Gingival Recession, Lack of Keratinized Gingiva
Recruiting
Periodontal Plastic Reconstruction of Soft Tissue Dehiscences After the Removal of Localized Gingival Enlargements
Localized Gingival Enlargement, Epulides
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 Criss cross sutures and Tissue tacs in people with Lack of Keratinized Tissue, 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 5 inclusion and 2 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 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (VAS Score) (time frame: 1,3,5,7 days post surgery). 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 2026.