NCT03338686

To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa

A Prospective Randomized Clinical Trial to Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

This study will compare two commonly used soft tissue grafting techniques (free gingival graft, FGG vs. connective tissue graft, CTG) to augment the soft tissue around dental implants with a lack of keratinized mucosa. To investigators knowledge, these 2 types of grafts have not been compared for differences in clinical (amount of KM increase, tissue thickness increase and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.

Detailed description

Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Soft tissue grating (with FGG or CTG) aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants in question. While FGG is typically associated with higher postoperative discomfort than CTG, it has also been considered the gold standard in the treatment of these clinical conditions. Specific aims for this project include the evaluation of: * KM width at 6 and 12 months following grafting with FGG and CTG * Change in tissue thickness of the grafted sites at 6 and 12 months * Esthetic outcomes using a newly developed peri-implant esthetic scale at 6 and 12 month * Patient centered outcomes including pain, bleeding, swelling and change in daily activities at 1 week for both groups and at 1 month for the CTG group

Conditions

• Dental Implants
• Alveolar Mucosa

Interventions

Type	Name	Description
PROCEDURE	Free Gingival Graft (FGG)	Free Gingival Graft (FGG) was performed on all study sites in this arm.
PROCEDURE	Connective Tissue Graft followed by Laser Gingivoplasty	Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.

Timeline

• Start date: 2016-01-07
• Primary completion: 2018-10-09
• Completion: 2021-06-30
• First posted: 2017-11-09
• Last updated: 2021-09-22
• Results posted: 2021-04-08

Locations

1 site across 1 country: United States