Skip to main content
Clinical Trials/NCT05801315
NCT05801315
Completed
Not Applicable

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

University of Siena1 site in 1 country52 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-implant Mucositis
Sponsor
University of Siena
Enrollment
52
Locations
1
Primary Endpoint
Bleeding on probing
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
March 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicola Discepoli

Professor

University of Siena

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Probing pocket depth change(12 months)

Study Sites (1)

Loading locations...

Similar Trials