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.
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- What is being studied
- The protocol lists: Free gingival grafting (FGG) using titanium tacks for stabilization, Free gingival grafting (FGG) using sutures for stabilization..
- Who it may be relevant to
- Registry conditions: To Clinically Compare Post-operative Pain Between Free Gingival Grafts Stabilization Around Natural Teeth Using Titanium Tacks vs Suturing Technique. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
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
Primary outcome measures
- Postoperative pain [Time frame: Daily for the first 7 days post-surgery.]
Secondary outcome measures (7)
- Keratinized tissue width (KTW) [Time frame: Week 12, Week 24]
- Intra-operative/procedure time (PT) [Time frame: During the free gingival graft stabilization procedure]
- Daily life interference [Time frame: Daily for the first 7 days post-surgery.]
- Gingival thickness [Time frame: Week 12, Weeks 24.]
- Post-operative Pain [Indirect] [Time frame: Daily for the first 7 days post-surgery.]
- Plaque Index [Time frame: Week 12, Week 24.]
- Graft dimensions [Time frame: Week 12, Week 24.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry and Oral Medicine, Cairo University, Cairo. — Cairo
Identifiers
NCT: NCT07655349 · 28/1/2025