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

NCT03338686 | Completed Results

• 1 other identifier: STS-15
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implants; Alveolar Mucosa

Keywords

Keratinized tissue; Keratinized mucosa; Attached mucosa; Dental implants; Free gingival graft; Connective tissue graft; Patient-centered outcomes

Outcome Measures

Primary Outcomes (1)

• The Increase in Keratinized Mucosa (in mm) Between the Two Grafts

  Compare the increase in keratinized mucosa (KM) between two commonly used soft tissue grafting techniques (FGG and CTG) by quantifying KM widths (in mm) at 12 months following soft tissue grafting.

  From baseline to 12 months

Secondary Outcomes (2)

• Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG

  From baseline to 12 months

• Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG

  From baseline to 12 months

Study Arms (2)

Free Gingival Graft

ACTIVE COMPARATOR

Free Gingival Graft (FGG)

Procedure: Free Gingival Graft (FGG)

Connective Tissue Graft followed by Laser Gingivoplasty

EXPERIMENTAL

Connective Tissue Graft (CTG) followed by Laser Gingivoplasty

Procedure: Connective Tissue Graft followed by Laser Gingivoplasty

Interventions

Free Gingival Graft (FGG) PROCEDURE

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

Also known as: palatal autogenous soft tissue graft

Free Gingival Graft

Connective Tissue Graft followed by Laser Gingivoplasty PROCEDURE

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

Also known as: palatal autogenous subepithelial soft tissue graft

Connective Tissue Graft followed by Laser Gingivoplasty

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

Location

Limitations and Caveats

randomization was performed by site (implant) due to challenges recruiting sufficient participants for both arms

Results Point of Contact

• Title: Ramzi Abou-Arraj
• Organization: University of Alabama at Birmingham

rva@uab.edu

2059344506

Study Officials

• Ramzi V Abou-Arraj, DDS, MS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: November 9, 2017
• Study Start: January 7, 2016
• Primary Completion: October 9, 2018
• Study Completion: June 30, 2021
• Last Updated: September 22, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-08

Locations

US (1)