To Clinically Compare Post-operative Pain Between Free Gingival Grafts Stabilization Around Natural Teeth Using Titanium Tacks vs Suturing TechniqueNCT07655349

Evaluation of Post-operative Pain After Stabilization of Free Gingival Graft for Keratinized Tissue Augmentation Around Natural Teeth Using Titanium Tacks Versus Standard Suturing Technique.

A study testing Free gingival grafting (FGG) using titanium tacks for stabilization and Free gingival grafting (FGG) using sutures for stabilization. in people with To Clinically Compare Post-operative Pain Between Free Gingival Grafts Stabilization Around Natural Teeth Using Titanium Tacks vs Suturing Technique, run by Karim Abdelrahim Mohamed Abdelsamad at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The goal of this clinical trial is to learn whether titanium tacks can be used as an alternative to sutures for stabilization of free gingival grafts (FGG) around natural teeth. It will also evaluate the effect of each stabilization technique on patient comfort and clinical outcomes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: To Clinically Compare Post-operative Pain Between Free Gingival Grafts Stabilization Around Natural Teeth Using Titanium Tacks vs Suturing Technique
What is being tested?: Free gingival grafting (FGG) using titanium tacks for stabilization and Free gingival grafting (FGG) using sutures for stabilization.
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteEgypt
Study dates: 17 Mar 2025to 1 Jul 2027
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

Patients age 18 years or older.
Patients with healthy systemic condition.
Indication for FGG treatment (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession) around natural teeth.
Keratinized tissue width (KTW) < 2 mm.
Good oral hygiene.
Cooperative patients.

Who cannot join

Pregnant females.
Smokers: a contraindication for any plastic periodontal surgery.
Unmotivated and uncooperative patients with poor oral hygiene.
Patients with habits that may compromise the longevity and affect the result of the study as parafunctional habits.
Patients who have undergone periodontal surgery in the same area within 6 months.

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

Faculty of Dentistry and Oral Medicine, Cairo University, Cairo.
Cairo, Cairo Governorate, 11553
Karim Abdelsamad, 00201006521672, karim.abdelsamad@dentistry.cu.edu.eg
Recruiting

Other trials in Egypt

About this study

Official title: Clinical Evaluation of Titanium Tacks Used for the Stabilization of Free Gingival Graft in Gingival Augmentation Around Natural Teeth: A Randomized Controlled Clinical Trial

The main questions it aims to answer are:

Does stabilization of free gingival grafts using titanium tacks reduce post-operative pain compared with conventional suturing?
Does stabilization of free gingival grafts using titanium tacks affect clinical outcomes such as keratinized tissue width, gingival thickness, graft dimensions, procedure time, plaque accumulation, and interference with daily activities?

Researchers will compare free gingival graft stabilization using titanium tacks with the conventional suturing technique to determine whether titanium tacks provide comparable or improved outcomes.

Participants will:

Receive a free gingival graft around natural teeth requiring augmentation of keratinized gingival tissue.
Be assigned to have the graft stabilized either with titanium tacks or with conventional resorbable sutures.
Attend scheduled follow-up visits for clinical examinations and measurements.
Report their post-operative pain levels using a Visual Analogue Scale (VAS).
Complete assessments related to daily life interference during the healing period.
Undergo evaluation of keratinized tissue width, gingival thickness, graft dimensions, plaque index, and procedure time.

Conditions: To Clinically Compare Post-operative Pain Between Free Gingival Grafts Stabilization Around Natural Teeth Using Titanium Tacks vs Suturing Technique
Being tested: Free gingival grafting (FGG) using titanium tacks for stabilization, Free gingival grafting (FGG) using sutures for stabilization.
Keywords: Free gingival graft, FGG, Titanium tacks, FGG titanium tacks, Free Gingival Graft Titanium tacks, Titanium tacks for stabilization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Free gingival grafting (FGG) using titanium tacks for stabilizationProcedure or surgery
According to the graft size, 2 to 5 titanium tacks will be used to stabilize and secure the free gingival graft in place to the periosteum at the recipient bed as needed, through anchoring in inter-septal bone and avoiding teeth roots.
Free gingival grafting (FGG) using sutures for stabilization.Procedure or surgery
Stabilization of the free gingival autograft in place using a 5-0 or 6-0 resorbable Prolene suture using a combination of two interrupted sutures, anchoring the grafted tissue to the base of the anatomical papillae, and a horizontal mattress compression suture anchored to the periosteum apical to the bone dehiscence and suspended around the palatal or lingual cingulum of the tooth with the recession defect, allowing for intimate contact ensuring proper perfusion and consequent revascularization of the graft.

Study groups in NCT07655349
Study group	Role	What they receive
Free gingival grafting (FGG) using titanium tacks for stabilization	Experimental	According to the graft size, 2 to 5 titanium tacks will be used to stabilize and secure the free gingival graft in place to the periosteum at the recipient bed as needed, through anchoring in inter-septal bone and avoiding teeth roots. The FGG will be stretched by fixing one tack at its distal end, then another tack at its mesial one, followed by the other tacks as required. Receives: Procedure: Free gingival grafting (FGG) using sutures for stabilization.
Free gingival grafting (FGG) using sutures for stabilization	Active comparator	Stabilization of the free gingival autograft in place using a 5-0 or 6-0 resorbable Prolene suture using a combination of two interrupted sutures, anchoring the grafted tissue to the base of the anatomical papillae, and a horizontal mattress compression suture anchored to the periosteum apical to the bone dehiscence and suspended around the palatal or lingual cingulum of the tooth with the recession defect, allowing for intimate contact ensuring proper perfusion and consequent revascularization of the graft. Receives: Procedure: Free gingival grafting (FGG) using titanium tacks for stabilization

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative pain
Visual Analogue Scale (VAS) with numerical scale from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 1 week postoperatively.
Measured: Daily for the first 7 days post-surgery.

Secondary outcomes (7)

Keratinized tissue width (KTW)
Will be measured from the MGJ to the free gingival margin. The MGJ will be identified using the roll technique.
Measured: Week 12, Week 24
Intra-operative/procedure time (PT)
Will be measured using a stopwatch from the beginning till the end of each procedure.
Measured: During the free gingival graft stabilization procedure
Daily life interference
It is based on the level of interference of surgical procedure on the patient's normal daily life for the first week after surgery.
Measured: Daily for the first 7 days post-surgery.
Gingival thickness
An endodontic file and a 3 mm diametersilicon disc stop will be used to measure gingival thickness 2mm apical to the gingival border. The file will be inserted into the soft tissue with mild pressure, perpendicular to the mucosal surface, until a firm surface is felt. The silicon disc stop will be then pressed against the soft tissue, with the coronal border covering the soft tissue boundary.
Measured: Week 12, Weeks 24.
Post-operative Pain [Indirect]
It is based on the amount of analgesics patient consumes, only if needed, during the first week after surgery. This will be measured by the number of pills consumed by the patient after both the pretreatment and 6h post-treatment doses.
Measured: Daily for the first 7 days post-surgery.
Plaque Index
- 0 No plaque in the gingival area.
- 1 A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
- 2 Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- 3 Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Measured: Week 12, Week 24.
Graft dimensions
Will be measured from standardized images using "Image J Software" for standardization of measurements and readings.
Measured: Week 12, Week 24.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 20251 Jul 2027

First posted17 Jun 2026
Study start17 Mar 2025
Primary completion1 Feb 2027 (estimated)
Study completion1 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for To Clinically Compare Post-operative Pain Between Free Gingival Grafts Stabilization Around Natural Teeth Using Titanium Tacks vs Suturing TechniqueStudies 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: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07655349
Sponsor's protocol ID: 28/1/2025
Status last verified: May 2026
First submitted: 12 Jun 2026
Last updated: 17 Jun 2026
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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Titanium Tacks Used for the Stabilization of Free Gingival Graft in Gingival Augmentation Around Natural Teeth: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT07655349
Acronym / sponsor ID: 28/1/2025
Conditions: To Clinically Compare Post-operative Pain Between Free Gingival Grafts Stabilization Around Natural Teeth Using Titanium Tacks vs Suturing Technique
Keywords: Free gingival graft, FGG, Titanium tacks, FGG titanium tacks, Free Gingival Graft Titanium tacks, Titanium tacks for stabilization
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: Karim Abdelrahim Mohamed AbdelsamadUniversity, hospital or other
Study start: 17 Mar 2025 (actual)
Primary completion: 1 Feb 2027 (estimated)
Study completion: 1 Jul 2027 (estimated)
First posted: 17 Jun 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.

The main questions it aims to answer are:

Does stabilization of free gingival grafts using titanium tacks reduce post-operative pain compared with conventional suturing?
Does stabilization of free gingival grafts using titanium tacks affect clinical outcomes such as keratinized tissue width, gingival thickness, graft dimensions, procedure time, plaque accumulation, and interference with daily activities?

Researchers will compare free gingival graft stabilization using titanium tacks with the conventional suturing technique to determine whether titanium tacks provide comparable or improved outcomes.

Participants will:

Receive a free gingival graft around natural teeth requiring augmentation of keratinized gingival tissue.
Be assigned to have the graft stabilized either with titanium tacks or with conventional resorbable sutures.
Attend scheduled follow-up visits for clinical examinations and measurements.
Report their post-operative pain levels using a Visual Analogue Scale (VAS).
Complete assessments related to daily life interference during the healing period.
Undergo evaluation of keratinized tissue width, gingival thickness, graft dimensions, plaque index, and procedure time.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Free gingival grafting (FGG) using titanium tacks for stabilization	Experimental	Procedure: Free gingival grafting (FGG) using sutures for stabilization.According to the graft size, 2 to 5 titanium tacks will be used to stabilize and secure the free gingival graft in place to the periosteum at the recipient bed as needed, through anchoring in inter-septal bone and avoiding teeth roots. The FGG will be stretched by fixing one tack at its distal end, then another tack at its mesial one, followed by the other tacks as required.
Free gingival grafting (FGG) using sutures for stabilization	Active comparator	Procedure: Free gingival grafting (FGG) using titanium tacks for stabilizationStabilization of the free gingival autograft in place using a 5-0 or 6-0 resorbable Prolene suture using a combination of two interrupted sutures, anchoring the grafted tissue to the base of the anatomical papillae, and a horizontal mattress compression suture anchored to the periosteum apical to the bone dehiscence and suspended around the palatal or lingual cingulum of the tooth with the recession defect, allowing for intimate contact ensuring proper perfusion and consequent revascularization of the graft.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients age 18 years or older.
Patients with healthy systemic condition.
Indication for FGG treatment (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession) around natural teeth.
Keratinized tissue width (KTW) < 2 mm.
Good oral hygiene.

Key exclusion criteria (5 listed)

Pregnant females.
Smokers: a contraindication for any plastic periodontal surgery.
Unmotivated and uncooperative patients with poor oral hygiene.
Patients with habits that may compromise the longevity and affect the result of the study as parafunctional habits.
Patients who have undergone periodontal surgery in the same area within 6 months.

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 grafting (FGG) using titanium tacks for stabilizationAccording to the graft size, 2 to 5 titanium tacks will be used to stabilize and secure the free gingival graft in place to the periosteum at the recipient bed as needed, through anchoring in inter-septal bone and avoiding teeth roots.	Procedure or surgery	Free gingival grafting (FGG) using sutures for stabilization
Free gingival grafting (FGG) using sutures for stabilization.Stabilization of the free gingival autograft in place using a 5-0 or 6-0 resorbable Prolene suture using a combination of two interrupted sutures, anchoring the grafted tissue to the base of the anatomical papillae, and a horizontal mattress compression suture anchored to the periosteum apical to the bone dehiscence and suspended around the palatal or lingual cingulum of the tooth with the recession defect, allowing for intimate contact ensuring proper perfusion and consequent revascularization of the graft.	Procedure or surgery	Free gingival grafting (FGG) using titanium tacks for stabilization

Primary outcome

Postoperative pain
Time frame: Daily for the first 7 days post-surgery.
Visual Analogue Scale (VAS) with numerical scale from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 1 week postoperatively.

7 secondary outcomes

Keratinized tissue width (KTW)
Time frame: Week 12, Week 24
Intra-operative/procedure time (PT)
Time frame: During the free gingival graft stabilization procedure
Daily life interference
Time frame: Daily for the first 7 days post-surgery.
Gingival thickness
Time frame: Week 12, Weeks 24.
Post-operative Pain [Indirect]
Time frame: Daily for the first 7 days post-surgery.
Plaque Index
Time frame: Week 12, Week 24.
Graft dimensions
Time frame: Week 12, Week 24.

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 17 Jun 2026.

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.

Faculty of Dentistry and Oral Medicine, Cairo University, Cairo.

Cairo, Egypt

00201006521672

karim.abdelsamad@dentistry.cu.edu.eg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 5 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 17 Jun 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?

Postoperative pain (time frame: Daily for the first 7 days post-surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07655349.

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 17 Jun 2026.