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

August 25, 2021 updated by: Ramzi V. Abou-Arraj, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0007
        • University of Alabama at Birmingham, School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Free Gingival Graft
Free Gingival Graft (FGG)
Procedure: Free Gingival Graft (FGG)
Free Gingival Graft (FGG) was performed on all study sites in this arm.
Other Names:
  • palatal autogenous soft tissue graft
Experimental: Connective Tissue Graft followed by Laser Gingivoplasty
Connective Tissue Graft (CTG) followed by Laser Gingivoplasty
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.
Other Names:
  • palatal autogenous subepithelial soft tissue graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Increase in Keratinized Mucosa (in mm) Between the Two Grafts
Time Frame: From baseline to 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG
Time Frame: From baseline to 12 months
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.
From baseline to 12 months
Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG
Time Frame: From baseline to 12 months
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.
From baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Ramzi V Abou-Arraj, DDS, MS, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2016

Primary Completion (Actual)

October 9, 2018

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

October 3, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STS-15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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