To Clinically Compare Post-operative Pain Between Free Gingival Grafts Stabilization Around Natural Teeth Using Titanium Tacks vs Suturing Technique
Conditions
Keywords
Free gingival graft, FGG, Titanium tacks, FGG titanium tacks, Free Gingival Graft Titanium tacks, Titanium tacks for stabilization
Brief 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.
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.
Sponsors
Karim Abdelrahim Mohamed Abdelsamad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients age 18 years or older. 2. Patients with healthy systemic condition. 3. 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. 4. Keratinized tissue width (KTW) \< 2 mm. 5. Good oral hygiene. 6. Cooperative patients.
Exclusion criteria
1. Pregnant females. 2. Smokers: a contraindication for any plastic periodontal surgery. 3. Unmotivated and uncooperative patients with poor oral hygiene. 4. Patients with habits that may compromise the longevity and affect the result of the study as parafunctional habits. 5. Patients who have undergone periodontal surgery in the same area within 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Keratinized tissue width (KTW) | Week 12, Week 24 | Will be measured from the MGJ to the free gingival margin. The MGJ will be identified using the roll technique. |
| Intra-operative/procedure time (PT) | During the free gingival graft stabilization procedure | Will be measured using a stopwatch from the beginning till the end of each procedure. |
| Daily life interference | 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. |
| Gingival thickness | 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. |
| Post-operative Pain [Indirect] | 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. |
| Plaque Index | 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. |
| Graft dimensions | Week 12, Week 24. | Will be measured from standardized images using "Image J Software" for standardization of measurements and readings. |
Countries
Egypt
Outcome results
None listed