Impact of Glycine Therapy on Peri-implant Mucositis

Sponsor

Ohio State University (Other)

Overall Status

Completed

CT.gov ID

NCT05810558

Collaborator

(none)

Enrollment

Location

Arms

54.5

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Peri-implant Mucositis	Procedure: glycine powder air-powered debridement Procedure: Ultrasonic instrumentation	N/A

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

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 16, 2016

Actual Primary Completion Date :

Sep 30, 2017

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Arm 1 Ultrasonic Subjects will receive cleaning of the peri-implant sulcus using ultrasonic instrumentation	Procedure: 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
Experimental: Arm 2 Glycine Subjects will receive cleaning of the peri-implant sulcus using glycine powder air-powered debridement	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.

Arm

Intervention/Treatment

Placebo Comparator: Arm 1 Ultrasonic

Subjects will receive cleaning of the peri-implant sulcus using ultrasonic instrumentation

Procedure: 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

Experimental: Arm 2 Glycine

Subjects will receive cleaning of the peri-implant sulcus using glycine powder air-powered debridement

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.

Outcome Measures

Primary Outcome Measures

gingival inflammation [6 months]
presence of redness, bleeding on gentle probing from the peri-implant sulcus

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	College of Dentistry	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator: Purnima S Kumar, DDS, PhD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ohio State University

ClinicalTrials.gov Identifier:

NCT05810558

Other Study ID Numbers:

2016H0397

First Posted:

Apr 12, 2023

Last Update Posted:

Apr 12, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mucositis

Glycine

Study Results

No Results Posted as of Apr 12, 2023