Impact of Glycine Therapy on Peri-implant Mucositis

NCT ID: NCT05810558

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-16

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peri-implant Mucositis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1 Ultrasonic

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

Group Type PLACEBO_COMPARATOR

Ultrasonic instrumentation

Intervention Type PROCEDURE

The control treatment consists of supragingival and root debridement using an ultrasonic scaler on low-medium power and coronal polishing with fine grit paste

Arm 2 Glycine

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

Group Type EXPERIMENTAL

glycine powder air-powered debridement

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Purnima S Kumar, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

College of Dentistry

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Partido B, Saraswat S, Kumar PS. Impact of Glycine Powder Air-Abrasive Debridement on Peri-Implant Mucositis: A Randomized Control Trial of Clinical, Microbial, and Immunological Changes. Clin Oral Implants Res. 2025 Jan;36(1):82-91. doi: 10.1111/clr.14361. Epub 2024 Sep 28.

Reference Type DERIVED
PMID: 39340233 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016H0397

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Regenerative Treatment of Peri-implantitis
NCT06153212 ENROLLING_BY_INVITATION NA