Effect of Free Gingival Grafting on Peri-implant Health

NCT06392256 | Completed

• 1 other identifier: E-21071282-050.99-630224
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peri-implant Mucositis; Soft Tissue Inflammation

Keywords

Peri-implant Mucositis; Keratinized Mucosa; Non-surgical Therapy; Free Gingival Graft

Outcome Measures

Primary Outcomes (1)

• Bleeding on probing (BoP) - BoP extent

  The number of BoP around the implants

  3 and 6 months after the treatment

Secondary Outcomes (5)

• Percentage of complete disease resolution (%)

  3 and 6 months after the treatment

• Probing pocket depth (PPD)

  3 and 6 months after the treatment

• Keratinized mucosa width (KMW)

  3 and 6 months after the treatment

• Keratinized mucosa thickness (KMT)

  3 and 6 months after the treatment

• Peri-implant soft-tissue dehiscence [PISTD]

  3 and 6 months after the treatment

Study Arms (2)

PM-NS: Peri-implant mucositis-Non-surgical therapy

ACTIVE COMPARATOR

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

PM-NS-FGG: Peri-implant mucositis-Non-surgical therapy-Free Gingival Grafting

EXPERIMENTAL

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; Procedure: Free gingival Grafting

Interventions

Non surgical therapy PROCEDURE

Non-surgical submarginal instrumentation using titanium curettes with saline irrigation will be done once in the treatment session.

PM-NS-FGG: Peri-implant mucositis-Non-surgical therapy-Free Gingival Grafting; PM-NS: Peri-implant mucositis-Non-surgical therapy

Free gingival Grafting PROCEDURE

In the PM-NS-FGG group, soft tissue augmentation using a free gingival graft will be performed.

PM-NS-FGG: Peri-implant mucositis-Non-surgical therapy-Free Gingival Grafting

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Dentistry

Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (5)

• Verket A, Koldsland OC, Bunaes D, Lie SA, Romandini M. Non-surgical therapy of peri-implant mucositis-Mechanical/physical approaches: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:135-145. doi: 10.1111/jcpe.13789. Epub 2023 Feb 28.

  PMID: 36802083 BACKGROUND

• Rakic M, Tatic Z, Radovanovic S, Petkovic-Curcin A, Vojvodic D, Monje A. Resolution of peri-implant mucositis following standard treatment: A prospective split-mouth study. J Periodontol. 2024 Sep;95(9):842-852. doi: 10.1002/JPER.23-0507. Epub 2023 Dec 2.

  PMID: 38041803 BACKGROUND

• Galarraga-Vinueza ME, Tavelli L. Soft tissue features of peri-implant diseases and related treatment. Clin Implant Dent Relat Res. 2023 Aug;25(4):661-681. doi: 10.1111/cid.13156. Epub 2022 Nov 29.

  PMID: 36444772 BACKGROUND

• Schwarz F, Sager M, Golubovic V, Iglhaut G, Becker K. Horizontal mucosal thickness at implant sites as it correlates with the integrity and thickness of the buccal bone plate. Clin Oral Implants Res. 2016 Oct;27(10):1305-1309. doi: 10.1111/clr.12747. Epub 2016 Feb 10.

  PMID: 26864237 BACKGROUND

• Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

  PMID: 29926491 BACKGROUND

Study Officials

• Sila Cagri Isler, Asso Prof

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: May 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

TU (1)