Impact of Glycine-augmented Prophylaxis on Resolution of Peri-implant Mucositis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ohio State University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- gingival inflammation
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
gingival inflammation
Time Frame: 6 months
presence of redness, bleeding on gentle probing from the peri-implant sulcus
Secondary Outcomes
No secondary outcomes reported