The goal of this randomized clinical study is to compare in Adults Clinical Effect of Frenal Relocation without Free Gingival Graft Application on Keratinized Tissue Gain When Compared to Frenal Relocation with Free Gingival Graft Application. The main question aims to answer:
In Adults with high frenum attachment, will frenal relocation alone show a difference or enhance the keratinized tissue gain compared to frenal relocation procedure combined with the application of a free gingival graft?
Systemically healthy.
Good oral hygiene (Gingival and plaque index <20%)
Highly attached labial frenum.
Narrow sulcus depth.
Smokers who smoke >10 cigarettes per day.
Poor oral hygiene.
Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
Any systemic diseases or taking any medications that could affect wound healing.
Parallel
Frenotomy
Procedure/Surgery1. Two C-shaped partial thickness incisions will be placed on the two sides of the frenum leaving the underlying periosteum intact with a 15c# blade. 2. Relocation of the muscle attachment will be performed by blunt dissection using a mucoperiosteal elevator. 3. Undermining or separation of the epithelial boundaries from the underlying lip mucosa will then be performed by blunt dissection to facilitate tension-free suturing. 4. The epithelium will be sutured to the underlying periosteum using three interrupted periosteal 6-0 resorbable sutures and left to heal by secondary intention.
Frenotomy with Free Gingival Graft
Procedure/Surgery1. Two C-shaped partial thickness incisions will be placed on the two sides of the frenum leaving the underlying periosteum intact with a 15c# blade. 2. Relocation of the muscle attachment will be performed by blunt dissection using a mucoperiosteal elevator. 3. Undermining or separation of the epithelial boundaries from the underlying lip mucosa will then be performed by blunt dissection to facilitate tension-free suturing. 4. The desired size of the graft will be determined using a template and a free gingival graft will be harvested from the palate. 5. The graft will then be positioned and adapted firmly by suturing to the periosteum at the recipient site using 6-0 resorbable sutures. 6. The epithelium will be then sutured to the underlying periosteum using three interrupted periosteal 6-0 sutures and left to heal by secondary intention.
Keratinized tissue gain
Relapse Rate
Post-operative Pain (Numerical Rating scale)
Numerical Rating scale (NRS) Minimum Value: 0 (representing "no pain"). Maximum Value: 10 (representing "worst pain imaginable"). Outcome Interpretation: Higher scores represent a worse outcome, indicating greater or more severe pain intensity.
Mucosal Scar Index
Minimum Value: 0 (indicates an ideal result with no visible scar) Maximum Value: 10 (indicates the least favorable result with the most extreme scar) Outcome Interpretation: Higher scores mean a worse esthetic outcome. Scoring Breakdown The composite index evaluates post-surgical mucosal healing based on five specific parameters, each scored from 0 to 2: 1. Width 2. Height/contour 3. Color 4. Suture marks 5. Overall appearance
Patient Satisfaction Questionnaire
A patient satisfaction questionnaire (Derk et al., 2015) will be filled by the patients at the end of the study period. Only the primary satisfaction questions were included.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
