NCT03348111

Brief Summary

Considering the frequent occurence of peri-implantitis and mucositis, a multiple of treatment alternatives have been proposed including non-surgical and surgical procedures. However, it seems that the most effective treatment remains prevention of these diseases. The aim of this study is to emphasize on mucositis and peri-implantitis prevention using an air abrasion device the Air-Flow Master Piezon® with erythritol and chlorhexidine powder in order to eliminate and / or disorganize the biofilm responsible for peri-implant mucosa inflammation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 30, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

October 30, 2017

Last Update Submit

August 24, 2020

Conditions

Peri-ImplantitisMucositis

Keywords

MucositisPeri-ImplantitisAir-Flow Master Piezon®

Outcome Measures

Primary Outcomes (3)

  • Change from baseline peri-implant inflammation at 6 months

    bleeding on probing (binary criteria : yes/no)

    6 months

  • Change from baseline peri-implant inflammation at 4 months

    bleeding on probing (binary criteria : yes/no)

    4 months

  • Change from baseline peri-implant inflammation at 2 months

    bleeding on probing (binary criteria : yes/no)

    2 months

Secondary Outcomes (6)

  • stability of the bone level

    6 months

  • clinical attachment gain

    2 months

  • clinical attachment gain

    4 months

  • clinical attachment gain

    6 months

  • Quality of life with Oral Health Assessment Tool (OHAT)

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Air-polishing device

EXPERIMENTAL

Air polishing of the implant surface and/or elimination of the intrapocket biofilm using the air abrasion device Air-Flow Master Piezon®

Device: Air-polishing device

Interventions

Air-polishing deviceDEVICE

Air abrasion using the Air-Flow Master Piezon® with erythritol and Chlorhexidine powders on implants presenting clinical and radiographic signs of mucositis and peri-implantitis along with renewal of local oral hygiene instructions in order to reduce the inflammation locally

Also known as: Air-Flow Master Piezon®
Air-polishing device

Eligibility Criteria

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

You may qualify if:

  • adult patients,
  • possessing one or more implants prosthetically engaged with local peri-implant mucosa inflammation assessed by bleeding on probing
  • affiliated with a social security scheme

You may not qualify if:

  • patients with implant mobility or implants associated with vestibular cellulitis
  • not available patients for the follow-up visits
  • patients with known allergy to erythritol and/or Chlorhexidine powder
  • patients with chronic bronchitis
  • patients with asthma
  • patients with endocarditis
  • patients with contagious disease
  • patients with immunodeficiency
  • patients under radiotherapy and/or chemotherapy and/or antibiotics
  • not mastery of plaque control on the part of the patient (after education)
  • subjects under legal protection
  • pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse (Faculty of Dental Surgery)

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Peri-ImplantitisMucositis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Sara Laurencin, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 20, 2017

Study Start

June 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)