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.

June 12, 2026 updated by: Karim Abdelrahim Mohamed Abdelsamad

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 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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients age 18 years or older.
  2. Patients with healthy systemic condition.
  3. 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.
  4. Keratinized tissue width (KTW) < 2 mm.
  5. Good oral hygiene.
  6. Cooperative patients.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Free gingival grafting (FGG) using titanium tacks 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.
Procedure: 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.
Active Comparator: 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: Free gingival grafting (FGG) using titanium tacks 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Daily for the first 7 days post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized tissue width (KTW)
Time Frame: Week 12, Week 24
Will be measured from the MGJ to the free gingival margin. The MGJ will be identified using the roll technique.
Week 12, Week 24
Intra-operative/procedure time (PT)
Time Frame: During the free gingival graft stabilization procedure
Will be measured using a stopwatch from the beginning till the end of each procedure.
During the free gingival graft stabilization procedure
Daily life interference
Time Frame: Daily for the first 7 days post-surgery.
It is based on the level of interference of surgical procedure on the patient's normal daily life for the first week after surgery.
Daily for the first 7 days post-surgery.
Gingival thickness
Time Frame: Week 12, Weeks 24.
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.
Week 12, Weeks 24.
Post-operative Pain [Indirect]
Time Frame: Daily for the first 7 days post-surgery.
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.
Daily for the first 7 days post-surgery.
Plaque Index
Time Frame: Week 12, Week 24.
  • 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.
Week 12, Week 24.
Graft dimensions
Time Frame: Week 12, Week 24.
Will be measured from standardized images using "Image J Software" for standardization of measurements and readings.
Week 12, Week 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karim Abdelrahim Mohamed Abdelsamad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28/1/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Free gingival grafting (FGG) using sutures for stabilization.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe