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

Peri-implant Mucositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05801315
• Other study ID #: MU001
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 20, 2023

Study information

• Verified date: July 2023
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

Device:
• Glycine powder air polishing
Peri-implant mucositis sites treated with a glycine powder air polishing device (Air-Flow Master Piezon®).
• Full mouth ultrasonic debridement
Peri-implant mucositis sites are treated with thin ultrasonic tips.

Locations

Country	Name	City	State
Italy	AOUS	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Probing pocket depth change	Change in probing pocket depth measured in millimeter through a periodontal probe.	12 months