Impact of Glycine Therapy on Peri-implant Mucositis

Study Overview
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Brief Summary
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The purpose of this research study is to determine the impact of glycine powder air-abrasive debridement (GPAD) on the microbiology of the tissues surrounding dental implants with health and inflammation (peri-implant mucositis).

Detailed Description
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Peri-implant mucositis, or the infection of the gingival tissues surrounding a dental implant, and peri-implantitis, or the infection of the gingival tissue surrounding a dental implant with bone loss, can lead to the failure and eventual loss of dental implants. The prevalence of peri-implant mucositis ranges from 30.7-43% and the prevalence of peri-implantitis ranges from 9.6-22% with non-smokers. Traditional treatment of this disease has been through biofilm removal using ultrasonic instrumentation. Glycine is a non-essential amino acid that possesses an anti-inflammatory, immunomodulary, and a cytoprotective effect. The goal of this investigation is to examine the impact of glycine-augmented biofilm removal on resolution of peri-implant mucositis

Official Title
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Impact of Glycine-augmented Prophylaxis on Resolution of Peri-implant Mucositis

Conditions
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Peri-implant Mucositis

Intervention / Treatment
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* Procedure: glycine powder air-powered debridement
* Procedure: Ultrasonic instrumentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Must have >1 tooth-borne, non-splinted single dental implant Signs of healthy dental implants (pocket probing depth <4mm and a lack of bleeding upon probing at peri-implant site) OR Signs of peri-implant mucositis (> 4mm probing pocket depths at the dental implant site, bleeding upon probing at >1 peri-implant site, pre-brushing plaque score of > 1.9 (modified Plaque Index (mPI)), and radiographic evidence of bone loss less than 2mm). Exclusion Criteria: Uncontrolled medical condition (i.e. Diabetes, History of smoking <5 years) Pregnant or lactating females Untreated periodontal conditions Use of antibiotics in the past 3 months Subjects treated with medication for >2 weeks with known effects to the oral tissues (i.e. coumadin, phenytoin, nifedipine, cyclosporine, non-steroidal anti-inflammatory drugs) Signs of peri-implantitis (pocket probing depth of 4-6mm with bleeding upon probing at >1 peri-implant site AND radiographic bone loss) Dental implant mobility

Ages Eligible for Study
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Minimum Age: 21 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1 Ultrasonic<br>Subjects will receive cleaning of the peri-implant sulcus using ultrasonic instrumentation | Procedure: Ultrasonic instrumentation<br>* The control treatment consists of supragingival and root debridement using an ultrasonic scaler on low-medium power and coronal polishing with fine grit paste<br>|
| Experimental: Arm 2 Glycine<br>Subjects will receive cleaning of the peri-implant sulcus using glycine powder air-powered debridement | Procedure: glycine powder air-powered debridement<br>* The intervention treatment consist sof glycine powder air-abrasive debridement (GPAD) using a handheld air polishing device, disposable subgingival nozzle, and glycine powder The nozzle is inserted to the depth of the pocket and all surfaces of the implant (mesial, buccal, distal, lingual) debrided for 5 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gingival inflammation | presence of redness, bleeding on gentle probing from the peri-implant sulcus | 6 months |