Effect of Free Gingival Grafting on Peri-implant Health

April 11, 2025 updated by: Sıla Çağrı İşler, Gazi University

The Influence of Soft Tissue Phenotype Modification Following Free Gingival Grafting on the Treatment of Peri-implant Mucositis

The goal of this randomized clinical study is to investigate the impact of soft tissue phenotype modification following free gingival grafting (FGG) in addition to the non-surgical mechanical therapy of peri-implant mucositis (PM) with keratinized mucosa width (KMW) < 2 mm over a 6-month follow-up period. Therefore, the following questions related to the study are raised:

• Does soft tissue modification following free gingival grafting around the implants with KMW < 2 mm, in addition to non-surgical mechanical therapy of PM, affect the change in bleeding on probing and the rate of complete disease resolution?

Patients who apply to the Department of Periodontology, Faculty of Dentistry, Gazi University, are systemically healthy, have implant-supported restorations installed at least one year prior to their enrollment, and are diagnosed with PM on these implants will be selected for the study. Patients with KMW < 2 mm at the respective implant sites will be treated with non-surgical mechanical treatment combined with soft tissue augmentation with FGG or non-surgical mechanical treatment alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary goal of treating peri-implant mucositis (PM) is to disturb the dental implant biofilm and resolve inflammatory conditions. This aims to achieve treatment success or complete disease resolution, preventing its progression to peri-implantitis. Indeed, regardless of the non-surgical mechanical/physical instrumentation approaches and despite noticeable clinical improvements, none of the existing procedures would result in complete disease resolution [i.e., absence of bleeding on probing (BOP)] in peri-implant mucositis. Taking this into account, the execution of interventions targeted at managing modifiable risk factors plays a pivotal role in maintaining peri-implant health.

Despite the increasing evidence documenting that implant sites exhibiting either a lacking or a reduced keratinized mucosa (KM) of ≤2 mm demonstrate difficulties in eliminating bacterial biofilm, leading to inflammation around the soft tissue, the requirement for a minimum peri-implant KM width (KMW) to avoid peri-implant diseases has been a highly debated topic. Indeed, KM augmentation at implant sites with a reduced KMW has been reported to be associated with statistically significant lower plaque and gingival scores as well as peri-implant probing depths (PPD) when compared with non-augmented sites. However, there is no study evaluating primarily the effect of KM augmentation on maintaining peri-implant health and preventing peri-implant diseases.

Therefore, the aim of this study is to investigate the impact of soft tissue phenotype modification following free gingival grafting in addition to the non-surgical submarginal instrumentation of peri-implant mucositis over a 6-month follow-up period.

Study Type

Interventional

Enrollment (Actual)

43

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

  • Turkey
      • Ankara, Turkey, 06490
        • Gazi University Faculty 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Peri-implant Mucositis

  • Adult (>18 years old), systemically healthy patients,
  • Presence of at least one implant affected by peri-implant mucositis characterized by the presence of bleeding on probing and/or suppuration (BoP/SoP) and the absence of bone loss beyond crestal bone level changes that occur as a result of initial bone remodeling,
  • Presence of buccal peri-implant keratinized mucosa width (KMW) < 2 mm around the implants diagnosed with peri-implant mucositis,
  • Patients who have implant-supported restorations installed at least one year prior to their enrollment.

Exclusion Criteria:

  • Systemic diseases that could influence the outcomes of dental and surgical treatments such as uncontrolled diabetes (HbA1c > 7), active treatment phase for cancer, autoimmune diseases, osteoporosis, medications such as steroids, bisphosphonates, selective serotonin reuptake inhibitors (SSRIs), proton pump inhibitors (PPIs), and antihypertensives,
  • Consumption of anti-coagulants, anti-aggregation agents, antibiotics, or corticosteroid medications during the past three months,
  • Pregnancy or lactation,
  • History of soft tissue grafting at the respective implant sites,
  • Current untreated periodontal diseases,
  • Smokers (≥ 10 cigarettes per day),
  • Malpositioned implants.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PM-NS: Peri-implant mucositis-Non-surgical therapy
Professional mechanical plaque removal and submarginal instrumentation using titanium curettes will be performed in the non-surgical treatment of peri-implant mucositis with KMW < 2 mm.
Procedure: Non surgical therapy
Non-surgical submarginal instrumentation using titanium curettes with saline irrigation will be done once in the treatment session.
Experimental: PM-NS-FGG: Peri-implant mucositis-Non-surgical therapy-Free Gingival Grafting
Professional mechanical plaque removal and submarginal instrumentation using titanium curettes will be performed in the non-surgical treatment of peri-implant mucositis with KMW < 2 mm. Free gingival grafting will be done one month after the non-surgical treatment.
Procedure: Non surgical therapy
Non-surgical submarginal instrumentation using titanium curettes with saline irrigation will be done once in the treatment session.
Procedure: Free gingival Grafting
In the PM-NS-FGG group, soft tissue augmentation using a free gingival graft will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing (BoP) - BoP extent
Time Frame: 3 and 6 months after the treatment
The number of BoP around the implants
3 and 6 months after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of complete disease resolution (%)
Time Frame: 3 and 6 months after the treatment
The absence of BoP at more than one site per implant and deepest PPD≤5 mm.
3 and 6 months after the treatment
Keratinized mucosa width (KMW)
Time Frame: 3 and 6 months after the treatment
The distance between the peri-implant mucosal margin and the mucogingival junction and recorded to the nearest millimeter using a UNC periodontal probe
3 and 6 months after the treatment
Keratinized mucosa thickness (KMT)
Time Frame: 3 and 6 months after the treatment
KTT will be measured 1 mm below the mucosal margin inserting an endodontic reamer to the soft tissue, and measuring the distance between the tip of the reamer and the stopper through a digital caliper. Mucosal thickness was also categorized as thick (≥2 mm) and thin (<2 mm)
3 and 6 months after the treatment
Peri-implant soft-tissue dehiscence [PISTD]
Time Frame: 3 and 6 months after the treatment
The distance between the apical margin of the crown to the peri-implant mucosal margin, including exposure of the prosthetic abutment, with or without the exposure of the implant-treated surface
3 and 6 months after the treatment
Probing pocket depth (PPD)
Time Frame: 3 and 6 months after the treatment
The distance between the bottom of the pocket and mucosal margin around the implants
3 and 6 months after the treatment

Collaborators and Investigators

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

Sponsor

Gazi University

Investigators

  • Study Director: Sila Cagri Isler, Asso Prof, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2023

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-21071282-050.99-630224

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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