Non-surgical Treatment of Peri-implant Mucositis: FMUD vs FMUD and Air-Flow Master Piezon®

July 25, 2023 updated by: Nicola Discepoli, University of Siena

Treatment of Peri-implant Mucositis: Adjunctive Benefit of Glycine Powder Air Polishing Device to Professional Mechanical Biofilm Removal. A Randomized Parallel Arm Clinical Study

The aim of the present study is to evaluate the adjunctive effect of glycine-powder air-polishing (GPAP) to full-mouth ultrasonic debridement (Fm-UD) in the treatment of peri-implant mucositis, and to determine the predictive role of implant and patient-level variables for disease resolution. Both treatments are described in the literature, but few studies are available on their comparison.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

52 patients (132 implants) with peri-implant mucositis were included in this randomized parallel arm clinical study. Following baseline variables assessment, participants received Fm-UD. Implants allocated to the test group (n=64) were additionally treated with GPAP. Clinical outcomes were evaluated at 3 and 12 months following intervention. Complete and partial disease resolution were defined as absence of BoP (DR1) or <2 BoP+ sites (DR2), respectively.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Siena, Italy, 53100
        • AOUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age between 18 and 70 years old;
  • presence of one implant loaded at least one year before;
  • bleeding on probing and/or suppuration of the peri-implant mucosa;
  • pain and/or tenderness of the peri-implant mucosa;
  • good general health conditions.

Exclusion Criteria:

  • radiographic bone loss ≥ 2mm;
  • intake of anticoagulants, antiplatelet, antibiotic or cortisone drugs;
  • inability to perform oral hygiene maneuvers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full mouth ultrasonic debridement plus glycine powder air polishing
Plaque and calculus are firstly removed through full mouth ultrasonic debridement (FMUD) in all sites (both dental and implant). After this procedure an air polishing device (Air-flow Master Piezon®) is used as additional therapy to further debride peri-implant trans-mucosal tract.
Device: Glycine powder air polishing
Peri-implant mucositis sites treated with a glycine powder air polishing device (Air-Flow Master Piezon®).
Device: Full mouth ultrasonic debridement
Peri-implant mucositis sites are treated with thin ultrasonic tips.
Active Comparator: Full mouth ultrasonic debridement
Plaque and calculus are removed through full mouth ultrasonic debridement (FMUD) in all sites (both dental and implant).
Device: Full mouth ultrasonic debridement
Peri-implant mucositis sites are treated with thin ultrasonic tips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing
Time Frame: 12 months
After probing dental and implant sites a dichotomic value (0/1) is assigned for each site. 0: not bleeding site; 1: bleeding site.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing pocket depth change
Time Frame: 12 months
Change in probing pocket depth measured in millimeter through a periodontal probe.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

March 20, 2023

Study Completion (Actual)

March 20, 2023

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peri-implant Mucositis

Clinical Trials on Glycine powder air polishing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe