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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05801315
Enrollment
52
Registered
2023-04-06
Start date
2020-03-01
Completion date
2023-03-20
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implant Mucositis

Keywords

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

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.

Interventions

DEVICEGlycine powder air polishing

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

DEVICEFull mouth ultrasonic debridement

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

Sponsors

University of Siena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Bleeding on probing12 monthsAfter probing dental and implant sites a dichotomic value (0/1) is assigned for each site. 0: not bleeding site; 1: bleeding site.

Secondary

MeasureTime frameDescription
Probing pocket depth change12 monthsChange in probing pocket depth measured in millimeter through a periodontal probe.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026