Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID07471386

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

Led by Gazi University · Updated on 2026-03-13

30

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether increasing the width and thickness of keratinized mucosa around dental implants can improve outcomes in patients with peri-implantitis who have less than 2 mm of keratinized mucosa. The study compares non-surgical peri-implantitis treatment alone to the same treatment combined with a free gingival graft (FGG) procedure. This research aims to understand if adding mucosa augmentation helps control the disease better and supports peri-implant tissue health. All participants first receive non-surgical therapy involving mechanical cleaning of implant surfaces and saline irrigation. After one month, patients in the test group undergo an additional procedure where a graft is taken from the palate and placed to increase keratinized mucosa. The control group continues with supportive periodontal care without surgery. Clinical and radiographic evaluations are done regularly to assess treatment effects. Participants attend scheduled visits for measurements including probing depth, bleeding on probing, plaque levels, keratinized mucosa width and thickness, vestibular depth, and mucosal recession. These assessments are performed by trained examiners to monitor healing and tissue changes over 12 months. The primary outcome is the change in probing depth after treatment. Safety and effectiveness of the interventions are carefully tracked throughout the study period.

CONDITIONS

Brief Title

Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Non-smoker
  • Systemically healthy
  • Keratinized mucosa width less than 2 mm
  • Age between 18 and 75 years
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Non-surgical Peri-implantitis Therapy

Duration - 1 day

Participants receive mechanical debridement of peri-implant surfaces using titanium curettes and ultrasonic tips, along with saline irrigation and oral hygiene instructions.

1 visit (in-person)

Free Gingival Graft Surgery

Duration - 1 procedure session plus healing period

Participants in the test group receive a free gingival graft procedure 4-6 weeks after non-surgical therapy to increase the width and thickness of keratinized mucosa.

1 surgical visit plus follow-up visits

Supportive Peri-implant Care and Follow-up

Duration - Up to 12 months post-treatment

Participants in both groups continue with supportive peri-implant care and undergo clinical and radiographic evaluations to assess treatment outcomes.

Regular follow-up visits over 12 months

Trial Site Locations

Total: 1 location

1

Gazi University Faculty of Dentistry

Ankara, Turkey (Türkiye)

Actively Recruiting

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Research Team

S

Sila Cagri Isler, Prof. Dr.

B

Berrin Unsal, Prof Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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