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

The University of Alabama at Birmingham

Status

Completed

Conditions

Dental Implants

Alveolar Mucosa

Treatments

Procedure: Free Gingival Graft (FGG)

Procedure: Connective Tissue Graft followed by Laser Gingivoplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT03338686

STS-15

Details and patient eligibility

About

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.

Full 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

Enrollment

14 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

English speaking
At least 18 years old
Must be a patient of the UAB Dental School, able to read and understand informed consent document
One or more adjacent dental implants having <2mm in width of keratinized mucosa or attached mucosa <1mm around their buccal aspect Contra-lateral or opposing implant sites with above criteria may be included and randomly assigned to soft tissue graft type
No crestal bone loss or minimal bone resorption not extending apical to first implant thread
Presence of periodontally healthy neighboring teeth, healthy implants or edentulous ridge on either side of the involved site (s)
Implants requiring soft tissue grafting after placement (>2 months): implants with healing abutments awaiting restoration or after delivery of temporary/permanent restoration

Exclusion criteria

Non-English speaking
Less than 18 years old
Smokers/tobacco users (>10 cigarettes/day)
Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
Presence of peri-implantitis, acute infection and/or suppuration at the implant placement site (s)
Presence of soft tissue recession exposing threads at implant site
Presence of bony dehiscence at implant site (s)_ at time of surgery
Previous soft tissue grafting at the implant site (s)