NCT05810558

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

March 31, 2023

Last Update Submit

March 31, 2023

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (1)

  • gingival inflammation

    presence of redness, bleeding on gentle probing from the peri-implant sulcus

    6 months

Study Arms (2)

Arm 1 Ultrasonic

PLACEBO COMPARATOR

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

Procedure: Ultrasonic instrumentation

Arm 2 Glycine

EXPERIMENTAL

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

Procedure: glycine powder air-powered debridement

Interventions

glycine powder air-powered debridementPROCEDURE

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 2 Glycine
Ultrasonic instrumentationPROCEDURE

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 1 Ultrasonic

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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.

    PMID: 39340233DERIVED

Study Officials

  • Purnima S Kumar, DDS, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 12, 2023

Study Start

June 16, 2016

Primary Completion

September 30, 2017

Study Completion

December 30, 2020

Last Updated

April 12, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)