Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis

March 10, 2026 updated by: Sıla Çağrı İşler, Gazi University

Impact of Keratinized Mucosa Augmentation as an Adjunct to Non-Surgical Therapy in the Management of Peri-Implantitis

This study aims to increase the width and thickness of peri-implant keratinized mucosa (KM) by transferring a properly dimensioned free gingival graft (FGG) from the palatal donor site and to evaluate its effect as an adjunctive approach to non-surgical peri-implantitis therapy. The procedure is indicated for patients diagnosed with peri-implantitis who present with an inadequate KM (midbuccal KM height < 2 mm). One month after non-surgical therapy, patients in the test group will undergo keratinized mucosa augmentation using an FGG, while patients in the control group will continue with supportive periodontal therapy and regular follow-up visits. The primary outcome measure of the study is the change in probing depth (PD) at 12 months following peri-implantitis treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and Case Definition

Peri-implantitis is a disease that typically develops from peri-implant mucositis, an inflammatory condition affecting the soft tissues surrounding dental implants. If left untreated, peri-implant mucositis may progress to peri-implantitis, leading to loss of supporting hard and soft tissues. Clinical signs of peri-implantitis include bleeding on probing (BoP), erythema of the peri-implant mucosa, suppuration, and increased probing depths (PD ≥ 5 mm). The presence of peri-implant bone loss on radiographic examination is a key diagnostic criterion for peri-implantitis.

Although increased width and thickness of keratinized mucosa have been suggested to support peri-implant tissue stability, their role in maintaining peri-implant health and improving the response to peri-implantitis therapy remains controversial. Given the ongoing debate regarding the role of keratinized mucosa dimensions in modulating the response to non-surgical peri-implantitis therapy, further clinical evidence is warranted.

The hypothesis of this study is that adjunctive keratinized mucosa augmentation following non-surgical peri-implantitis therapy results in improved clinical outcomes compared to non-surgical treatment alone. Therefore, the aim of this study was to investigate whether adjunctive keratinized mucosa augmentation improves clinical and radiographic outcomes compared to non-surgical peri-implantitis therapy alone.

Study Population Inclusion Criteria

Systemically healthy adults (≥18 years of age)

Implant-supported restorations in function for at least one year prior to enrollment

Exclusion Criteria

Systemic conditions potentially affecting wound healing or treatment outcomes (e.g., uncontrolled diabetes, active cancer therapy)

Use of medications within the previous three months that could influence healing or inflammation (e.g., anticoagulants, antiplatelet agents, antibiotics, corticosteroids)

Pregnancy or lactation

Smoking ≥10 cigarettes/day

Untreated periodontitis

Malpositioned implants

Previous soft tissue grafting procedures at the implant site

Treatment Protocol

All patients will receive initial non-surgical peri-implantitis therapy, including mechanical debridement of the implant surface using titanium curettes and resin ultrasonic tips, along with saline irrigation for surface decontamination. Oral hygiene instructions will be reinforced in all patients.

In the test group, a free gingival graft procedure will be performed 4-6 weeks after completion of non-surgical therapy to increase the width and thickness of keratinized mucosa.

In the control group, no surgical intervention will be performed following non-surgical therapy, and patients will continue with supportive peri-implant care.

Clinical Parameters

All clinical parameters will be recorded by a calibrated examiner at predefined evaluation time points.

  1. Plaque Index (PI)

    Plaque accumulation will be assessed using the Plaque Index described by O'Leary et al. (1972). The presence or absence of plaque will be recorded at six sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). The plaque index will be expressed as a percentage of sites with visible plaque relative to the total number of assessed sites.

  2. Probing Depth (PD)

    Probing pocket depth will be measured using a William's periodontal probe, positioned parallel to the long axis of the implant. Measurements will be obtained at six sites per implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). The mean value of the six measurements will be calculated and used as the representative PPD value for each implant.

  3. Bleeding on Probing (BoP)

    Bleeding on probing will be assessed according to the criteria proposed by Ainamo and Bay (1975). Following gentle probing of the peri-implant sulcus, bleeding will be recorded as present (+) or absent (-) at six sites per implant. BoP will be expressed as the percentage of bleeding-positive sites.

  4. Width of Keratinized Mucosa (Mid-Buccal)

    The width of keratinized mucosa will be measured in millimeters at the mid-buccal aspect of each implant. Measurements will be taken from the peri-implant soft tissue margin to the mucogingival junction, encompassing both the free and attached keratinized mucosa.

  5. Thickness of Keratinized Mucosa (Mid-Buccal)

    Keratinized mucosa thickness will be assessed using a K-type endodontic file with a silicone stopper. The file will be gently inserted perpendicular to the mucosal surface at the mid-buccal aspect until bone contact is reached. The penetration depth will then be measured using a digital caliper.

  6. Vestibular Depth (Mid-Buccal)

    Vestibular depth will be measured at the mid-buccal aspect of the implant site as the vertical distance from the mucogingival junction to the deepest point of the vestibule. This measurement aims to assess changes in vestibular morphology potentially associated with soft tissue augmentation procedures.

  7. Mucosal Recession (MR)

Peri-implant mucosal recession will be measured as the linear distance (in millimeters) from a fixed reference point on the implant-supported restoration (e.g., the crown margin or implant shoulder) to the most coronal level of the peri-implant soft tissue margin at the mid-buccal aspect. Positive values will indicate apical displacement of the mucosal margin.

Study Type

Interventional

Enrollment (Estimated)

30

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 Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • 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:

  • Non-smoker
  • Systemically healthy
  • Keratinized mucosa witdh < 2 mm

Exclusion Criteria:

  • İntake of medications that impede periodontal tissue health and healing
  • Pregnancy or lactation

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: Control group
Non-surgical treatment of peri-implantitis alone
Other: Submucosal debridman + saline irrigation

Participants diagnosed with peri-implantitis and presenting with insufficient keratinized mucosa (width and thickness <2 mm) will first receive non-surgical peri-implant therapy. Mechanical debridement of the peri-implant surfaces will be performed using titanium curettes and implant-specific ultrasonic tips in order to remove bacterial biofilm without damaging the implant surface. Additionally, sterile saline solution will be used for submucosal irrigation after mechanical debridement. Patients will receive individualized oral hygiene instructions, including proper brushing techniques, and be suitable for implant-supported restorations.

Participants in this group will not receive any surgical or soft tissue grafting procedures.
Active Comparator: Test Group
Non-surgical treatment of perı-implantitis + Free gingival graft procedure
Procedure: Free gingival graft surgery

Participants diagnosed with peri-implantitis and presenting with insufficient keratinized mucosa (width and thickness <2 mm) will first receive non-surgical peri-implant therapy. Mechanical debridement of the peri-implant surfaces will be performed using titanium curettes and implant-specific ultrasonic tips in order to remove bacterial biofilm without damaging the implant surface. Additionally, sterile saline solution will be used for submucosal irrigation after mechanical debridement. Patients will receive individualized oral hygiene instructions, including proper brushing techniques, and be suitable for implant-supported restorations.

In this group, a free gingival graft (FGG) will be harvested from the palatal donor site under local anesthesia after completion of non-surgical therapy and resolution of acute inflammation.FGG will be stabilized using interrupted or continuous sutures.

Participants will be followed for clinical and radiographic evaluations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in PPD
Time Frame: Following at 12. months post-treatment
Following at 12. months post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding on Probing
Time Frame: Following at 12. months post-treatment
Following at 12. months post-treatment
Plaque index
Time Frame: Following at 12. months post-treatment
Following at 12. months post-treatment
Keratinized mucosa width
Time Frame: Following at 12. months post-treatment
Following at 12. months post-treatment
Keratinized mucosa thickness
Time Frame: Following at 12. months post-treatment
Following at 12. months post-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, Prof Dr, Gazi University Faculty of Dentistry

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)

March 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KAEK-07/063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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