Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07655349

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.

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Cairo Governorate, 11553, Egypt

Location status: Recruiting

Location contact

Karim Abdelsamad

CONTACT

[email protected]

00201006521672

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Free gingival grafting (FGG) using titanium tacks for stabilization

Procedure

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Graft dimensions

    Time frame: Week 12, Week 24.

    Will be measured from standardized images using "Image J Software" for standardization of measurements and readings.

Sponsors and collaborators

Lead sponsor

Karim Abdelrahim Mohamed Abdelsamad

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.