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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.

NCT07655349 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-17

No results posted yet for this study

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.

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

Interventions

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.

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.

Sponsors & Collaborators

  • Karim Abdelrahim Mohamed Abdelsamad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2027-02-01
Completion
2027-07-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07655349 on ClinicalTrials.gov