CompletedNot Applicable

Effect of Free Gingival Grafting on Peri-implant Health

Turkey (Türkiye)43 participantsStarted 2023-05-01

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Bleeding on probing (BoP) - BoP extent

Timeframe: 3 and 6 months after the treatment

Trial details

NCT IDNCT06392256

SponsorGazi University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01