Impact of Glycine Therapy on Peri-implant Mucositis

Peri-implant Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05810558
• Other study ID #: 2016H0397
• Status: Completed
• Phase: N/A
• Start date: June 16, 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2020
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

Procedure:
• glycine powder air-powered debridement
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.
• Ultrasonic instrumentation
The control treatment consists of supragingival and root debridement using an ultrasonic scaler on low-medium power and coronal polishing with fine grit paste

Locations

Country	Name	City	State
United States	College of Dentistry	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gingival inflammation	presence of redness, bleeding on gentle probing from the peri-implant sulcus	6 months