NCT05801315

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration 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

March 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

3.1 years

First QC Date

March 4, 2020

Last Update Submit

July 25, 2023

Conditions

Peri-implant Mucositis

Keywords

Peri-implant Mucositsair polishing devicenon-surgical treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • Probing pocket depth change

    12 months

Study Arms (2)

Full mouth ultrasonic debridement plus glycine powder air polishing

EXPERIMENTAL

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 polishingDevice: Full mouth ultrasonic debridement

Full mouth ultrasonic debridement

ACTIVE COMPARATOR

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

Device: Full mouth ultrasonic debridement

Interventions

Glycine powder air polishingDEVICE

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

Full mouth ultrasonic debridement plus glycine powder air polishing
Full mouth ultrasonic debridementDEVICE

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

Full mouth ultrasonic debridementFull mouth ultrasonic debridement plus glycine powder air polishing

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUS

Siena, 53100, Italy

Location

Related Publications (1)

  • Nicola D, Isabella R, Carolina C, Baldini N, Raffaele M. Treatment of peri-implant mucositis: Adjunctive effect of glycine powder air polishing to professional mechanical biofilm removal. 12 months randomized clinical study. Clin Implant Dent Relat Res. 2024 Apr;26(2):415-426. doi: 10.1111/cid.13304. Epub 2024 Feb 5.

    PMID: 38317375DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2020

First Posted

April 6, 2023

Study Start

March 1, 2020

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

IT(1)