Impact of Glycine Therapy on Peri-implant Mucositis

Not Applicable

Completed

• Conditions: Peri-implant Mucositis
• Interventions: Procedure: Ultrasonic instrumentation; Procedure: glycine powder air-powered debridement

• Registration Number: NCT05810558
• Lead Sponsor: Ohio State University

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 Timeline

• Study Start: 2016-06-16
• Primary Completion: 2017-09-30
• Study Completion: 2020-12-30
• Status Verified: 2023-03
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Last Update Submitted: 2023-03-31
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 Ultrasonic	Ultrasonic instrumentation	Subjects will receive cleaning of the peri-implant sulcus using ultrasonic instrumentation
Arm 2 Glycine	glycine powder air-powered debridement	Subjects will receive cleaning of the peri-implant sulcus using glycine powder air-powered debridement

Primary Outcome Measures

Name	Time	Method
gingival inflammation	6 months	presence of redness, bleeding on gentle probing from the peri-implant sulcus

Trial Locations

Locations (1)

College of Dentistry; 🇺🇸 Columbus, Ohio, United States