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

Primary Purpose

Peri-implant Mucositis

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Glycine powder air polishing

Full mouth ultrasonic debridement

About this trial

This is an interventional treatment trial for Peri-implant Mucositis focused on measuring Peri-implant Mucosits, air polishing device, non-surgical treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

AOUS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Full mouth ultrasonic debridement plus glycine powder air polishing

Full mouth ultrasonic debridement

Arm Description

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.

Plaque and calculus are removed through full mouth ultrasonic debridement (FMUD) in all sites (both dental and implant).

Outcomes

Primary Outcome Measures

Bleeding on probing

After probing dental and implant sites a dichotomic value (0/1) is assigned for each site. 0: not bleeding site; 1: bleeding site.

Secondary Outcome Measures

Probing pocket depth change

Change in probing pocket depth measured in millimeter through a periodontal probe.

Full Information

NCT ID

NCT05801315

First Posted

March 4, 2020

Last Updated

July 25, 2023

Sponsor

University of Siena

1. Study Identification

Unique Protocol Identification Number

NCT05801315

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

March 20, 2023 (Actual)

Study Completion Date

March 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Siena

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peri-implant Mucositis

Keywords

Peri-implant Mucosits, air polishing device, non-surgical treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Full mouth ultrasonic debridement plus glycine powder air polishing

Arm Type

Experimental

Arm Description

Arm Title

Full mouth ultrasonic debridement

Arm Type

Active Comparator

Arm Description

Plaque and calculus are removed through full mouth ultrasonic debridement (FMUD) in all sites (both dental and implant).

Intervention Type

Device

Intervention Name(s)

Glycine powder air polishing

Intervention Description

Peri-implant mucositis sites treated with a glycine powder air polishing device (Air-Flow Master Piezon®).

Intervention Type

Device

Intervention Name(s)

Full mouth ultrasonic debridement

Intervention Description

Peri-implant mucositis sites are treated with thin ultrasonic tips.

Primary Outcome Measure Information:

Title

Bleeding on probing

Description

After probing dental and implant sites a dichotomic value (0/1) is assigned for each site. 0: not bleeding site; 1: bleeding site.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Probing pocket depth change

Description

Change in probing pocket depth measured in millimeter through a periodontal probe.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

AOUS

City

Siena

ZIP/Postal Code

53100

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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