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

NCT ID: NCT03338686

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-07
• Study Completion Date: 2021-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Free Gingival Graft

Free Gingival Graft (FGG)

Group Type: ACTIVE_COMPARATOR

Free Gingival Graft (FGG)

Intervention Type: PROCEDURE

Free Gingival Graft (FGG) was performed on all study sites in this arm.

Connective Tissue Graft followed by Laser Gingivoplasty

Connective Tissue Graft (CTG) followed by Laser Gingivoplasty

Group Type: EXPERIMENTAL

Connective Tissue Graft followed by Laser Gingivoplasty

Intervention Type: PROCEDURE

Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.

Interventions

Free Gingival Graft (FGG)

Free Gingival Graft (FGG) was performed on all study sites in this arm.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

palatal autogenous soft tissue graft; palatal autogenous subepithelial soft tissue graft

Eligibility Criteria

Inclusion Criteria

1. English speaking

2. At least 18 years old

3. Must be a patient of the UAB Dental School, able to read and understand informed consent document

4. 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

5. No crestal bone loss or minimal bone resorption not extending apical to first implant thread

6. Presence of periodontally healthy neighboring teeth, healthy implants or edentulous ridge on either side of the involved site (s)

7. Implants requiring soft tissue grafting after placement (>2 months): implants with healing abutments awaiting restoration or after delivery of temporary/permanent restoration

Exclusion Criteria

1. Non-English speaking

2. Less than 18 years old

3. Smokers/tobacco users (>10 cigarettes/day)

4. Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing

5. Presence of peri-implantitis, acute infection and/or suppuration at the implant placement site (s)

6. Presence of soft tissue recession exposing threads at implant site

7. Presence of bony dehiscence at implant site (s)_ at time of surgery

8. Previous soft tissue grafting at the implant site (s)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ramzi V. Abou-Arraj

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramzi V Abou-Arraj, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STS-15

Identifier Type: -

Identifier Source: org_study_id