Effect of Free Gingival Grafting on Peri-implant Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peri-implant Mucositis Soft Tissue Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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

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.

Group Type ACTIVE_COMPARATOR

Non surgical therapy

Intervention Type 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

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.

Group Type EXPERIMENTAL

Non surgical therapy

Intervention Type PROCEDURE

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

Free gingival Grafting

Intervention Type PROCEDURE

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

Interventions

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Non surgical therapy

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

Intervention Type PROCEDURE

Free gingival Grafting

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes