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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 9, 2018

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

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Free Gingival Graft
    • Free Gingival Graft (FGG)
  • Experimental: Connective Tissue Graft followed by Laser Gingivoplasty
    • Connective Tissue Graft (CTG) followed by Laser Gingivoplasty

Clinical Trial Outcome Measures

Primary Measures

  • The increase in keratinized mucosa (in mm) between the two grafts
    • Time Frame: From baseline to 6 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 6 months following soft tissue grafting.
  • 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.

Secondary Measures

  • Measure the increase of KM width (in mm) as a result of laser gingivoplasty (GP) in the CTG group
    • Time Frame: From baseline to 6 months
    • Using a periodontal probe, KM width will be measured (in mm) at 6 months following laser gingivoplasty (GP) in the CTG group
  • Measure the increase of KM width (in mm) as a result of laser gingivoplasty (GP) in the CTG group
    • Time Frame: From baseline to 12 months
    • Using a periodontal probe, KM width will be measured (in mm) at 6 months following laser gingivoplasty (GP) in the CTG group
  • Measure changes in tissue thickness (in mm) between FGG and CTG
    • Time Frame: From baseline to 6 months
    • Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.
  • Measure changes in tissue thickness (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.
  • Assess esthetic outcomes
    • Time Frame: From baseline to 6 months
    • Assess esthetic outcomes using a newly developed peri-implant esthetic score (PIES)
  • Assess esthetic outcomes
    • Time Frame: From baseline to 12 months
    • Assess esthetic outcomes using a newly developed peri-implant esthetic score (PIES)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ramzi V. Abou-Arraj, Principal Investigator – University of Alabama at Birmingham
  • Overall Official(s)
    • Ramzi V Abou-Arraj, DDS, MA, Principal Investigator, University of Alabama at Birmingham

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