Evaluation of Post-operative Pain After Stabilization of Free Gingival Graft for Keratinized Tiss… (NCT07655349) | Clinical Trial Compass
RecruitingNot Applicable
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.
Egypt24 participantsStarted 2025-03-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares titanium tacks to standard suturing for holding the gum graft in place — can you explain what titanium tacks actually are, and whether there are any specific risks to my gums or teeth from using them compared to stitches?
2Since this study is still recruiting and is listed as Phase NA, meaning it's a procedural comparison rather than a drug trial, what does that mean for how much is already known about the safety and effectiveness of titanium tacks for this type of graft?
3The main thing being measured here is post-operative pain — how will my pain be tracked during the study, and what pain management options would be available to me regardless of which technique I'm assigned to?
4If I'm randomly assigned to the suturing group rather than the titanium tacks group, would my graft procedure still be considered a standard-of-care approach, or would either option be considered experimental?
5Given that this trial is specifically about free gingival grafts around natural teeth, is this type of graft the most appropriate procedure for my particular situation, or are there alternative treatments I should consider before deciding whether to participate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative pain
Timeframe: Daily for the first 7 days post-surgery.