Effect of Keratinized Mucosa on Peri-implant Health

Study Overview
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Brief Summary
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The aim of this clinical study is to evaluate the significance of keratinized mucosa and to investigate the influence of free gingival graft procedure on peri-implant health status in patients after prothesis delivery.

Detailed Description
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The study will be conducted in Faculty of Dentistry, Kutahya Health Sciences University . The patients who applied to the Department of Periodontology, received dental implant treatment, and required routine follow-up for the maintenance of peri-implant health will be included. Clinical and radiographic examinations will be performed at baseline (prothesis delivery) and at the end of the 3rd, 6th month, 1st year following the prosthetic loading. During clinical examination probing depth (PD), modified plaque index (mPI) and modified bleeding index (mBI) measurements will be evaluated with the Williams periodontal probe. These measurements will be taken at four points of the implant (mid-buccal, mesio-buccal, disto-buccal and mid-lingual) and these four measurements will be averaged for each implant. In addition, the amount of keratinized mucosa (KM) in the implant sites will be evaluated by measuring the mucosal margin and mucogingival junction on the vestibular surface with the same probe. After clinical examination, a periapical radiograph will be taken using a parallel technique to determine marginal bone loss surrounding the implant. The distance between the implant neck and the most coronal part of the alveolar crest will be measured on the mesial and distal surfaces for each implant on the obtained radiographs and the average of the two measurements will be taken. The parameters checked during clinical and radiographic examination will be compared between patients with or without keratinized mucosa and whose keratinized mucosa has been increased by free gingival graft.

Official Title
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Clinical and Radiographic Evaluation of the Effect of Keratinized Mucosa on Peri-implant Health

Conditions
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Keratinized Mucosa, Dental Implant, Free Gingival Graft

Intervention / Treatment
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* Procedure: Free gingival graft procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being over the age of 18 Having dental implant treatment and prosthetic restoration Not having received bone augmentation treatment at the implant site To comply with maintenance controls after dental implant treatment Exclusion Criteria: Pregnancy Having used systemic antibiotics within 6 weeks prior to the start of the study Having a disease that affects bone and soft tissue metabolism, such as hyperthyroidism, hyperparathyroidism, and uncontrolled diabetes mellitus Using drugs that cause immunosuppression Using a medicine that affects bone metabolism, such as a bisphosphonate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Keratinized Mucosa Sufficient (KMS)<br>Implants exhibiting the width of keratinized mucosa (KM) ≥2 mm at the midbuccal aspect | |
| No Intervention: Keratinized Mucosa Deficient (KMD)<br>Implants exhibiting KM<2 mm at the midbuccal aspect | |
| Experimental: Free Gingival Graft (FGG)<br>Implants with KM<2 mm initially and having surgically increased keratinized mucosa with free gingival graft after prothesis delivery | Procedure: Free gingival graft procedure<br>* Free gingival graft procedure applied to implants with KM<2 mm to increase the width of keratinized mucosa surrounding them<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss | Change of marginal bone loss measured from periapical radiographs | Baseline, 3rd month, 6th month and 1st year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified bleeding index | Parameter showing peri-implant mucosa inflammation | Baseline, 3rd month, 6th month and 1st year | 
| Probing depth | The depth of peri-implant sulcus in millimeters | Baseline, 3rd month, 6th month and 1st year | 
| Modified plaque index | Parameter showing oral hygiene performance | Baseline, 3rd month, 6th month and 1st year |