RecruitingNot ApplicableNCT07655349

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.

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


Sponsor

Karim Abdelrahim Mohamed Abdelsamad

Enrollment

24 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Free gingival grafting (FGG) using sutures for stabilization. and a procedure called Free gingival grafting (FGG) using titanium tacks for stabilization for people with to clinically compare post-operative pain between free gingival grafts stabilization around natural teeth using titanium tacks vs suturing technique. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFree 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.

PROCEDUREFree 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.


Locations(1)

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

Cairo, Cairo Governorate, Egypt

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NCT07655349