Effect of Free Gingival Grafting on Peri-implant Health

Peri-implant Mucositis Clinical Trial

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

Status Recruiting

Clinical Trial Summary

The goal of this randomized-controlled 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, in addition to non-surgical mechanical therapy of PM, affect the complete disease resolution?

• Does the presence of KMW < 2 mm around the implants exhibit similar outcomes compared to the sites with sufficient KMW (i.e., ≥ 2 mm) for professional mechanical plaque removal?

Patients who apply to the Department of Periodontology, Faculty of Dentistry, Gazi University, are systemically healthy, have implant-supported fixed 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. As a positive control group, those who apply to the same department, have implants in function as noted during routine annual maintenance appointments, and are diagnosed as healthy will be selected.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Inflammation
• Mucositis
• Peri-implant Mucositis
• Soft Tissue Inflammation

• NCT number: NCT06392256
• Study type: Interventional
• Source: Gazi University
• Contact: Assoc Prof Dr
• Phone: +905069966074
• Email: silaisler@gazi.edu.tr
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Completion date: August 15, 2024