Back to resultsImpact of Glycine Therapy on Peri-implant Mucositis
Primary Purpose
Peri-implant Mucositis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
glycine powder air-powered debridement
Ultrasonic instrumentation
Sponsored by
About this trial
This is an interventional prevention trial for Peri-implant Mucositis
Eligibility Criteria
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
Sites / Locations
- College of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Arm 1 Ultrasonic
Arm 2 Glycine
Arm Description
Subjects will receive cleaning of the peri-implant sulcus using ultrasonic instrumentation
Subjects will receive cleaning of the peri-implant sulcus using glycine powder air-powered debridement
Outcomes
Primary Outcome Measures
gingival inflammation
presence of redness, bleeding on gentle probing from the peri-implant sulcus
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05810558
Brief Title
Impact of Glycine Therapy on Peri-implant Mucositis
Official Title
Impact of Glycine-augmented Prophylaxis on Resolution of Peri-implant Mucositis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2016 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 Ultrasonic
Arm Type
Placebo Comparator
Arm Description
Subjects will receive cleaning of the peri-implant sulcus using ultrasonic instrumentation
Arm Title
Arm 2 Glycine
Arm Type
Experimental
Arm Description
Subjects will receive cleaning of the peri-implant sulcus using glycine powder air-powered debridement
Intervention Type
Procedure
Intervention Name(s)
glycine powder air-powered debridement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasonic instrumentation
Intervention Description
The control treatment consists of supragingival and root debridement using an ultrasonic scaler on low-medium power and coronal polishing with fine grit paste
Primary Outcome Measure Information:
Title
gingival inflammation
Description
presence of redness, bleeding on gentle probing from the peri-implant sulcus
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Purnima S Kumar, DDS, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Dentistry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Glycine Therapy on Peri-implant Mucositis
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