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OpenTrials
Completed

NCT Number: NCT05801315

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

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.

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Key information

Conditions

Peri-implant Mucositis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOUS

Siena, 53100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glycine powder air polishing

Device

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

Full mouth ultrasonic debridement

Device

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

Primary outcomes

  1. 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

  1. Probing pocket depth change

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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