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Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device (PERIFLOW)

Primary Purpose

Peri-Implantitis, Mucositis

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Air-polishing device
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring Mucositis, Peri-Implantitis, Air-Flow Master Piezon®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital Toulouse (Faculty of Dental Surgery)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Air-polishing device

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline peri-implant inflammation at 6 months
bleeding on probing (binary criteria : yes/no)
Change from baseline peri-implant inflammation at 4 months
bleeding on probing (binary criteria : yes/no)
Change from baseline peri-implant inflammation at 2 months
bleeding on probing (binary criteria : yes/no)

Secondary Outcome Measures

stability of the bone level
bone level assessed by X-ray
clinical attachment gain
The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain
clinical attachment gain
The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain
clinical attachment gain
The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain
Quality of life with Oral Health Assessment Tool (OHAT)
The Oral Health Assessment Tool (OHAT) was a component of the Best Practice Oral Health Model for Australian Residential Care study. The OHAT provided institutional carers with a simple, eight category screening tool to assess residents' oral health, including those with dementia
Quality of life with the Geriatric Oral Health Assessment Index (GOHAI)
The Geriatric Oral Health Assessment Index (GOHAI) is a self-reported measure designed to assess the oral health problems of older adults

Full Information

First Posted
October 30, 2017
Last Updated
August 24, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03348111
Brief Title
Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device
Acronym
PERIFLOW
Official Title
Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No participant enrolled
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Peri-implant infections (mucositis and peri-implantitis) depict an increasing focus in dental practice and implantology. mean prevalence of mucositis is of 43% and periimplantitis of 22%. Consequences for the implant without successful treatment range from local reversible inflammation (mucositis) to implant loss (periimplantitis). These lead to functional, social and esthetic prejudices for patients. The main factor for establishment of peri-implant infections is the formation and maturation of the bacterial biofilm. Peri-implantitis and mucositis treatment require the removal of the bacterial biofilm and the disinfection of the implant surface. Because of special surface conditions and structures, it is more difficult to remove bacterial biofilms from implant surfaces than teeth. the key to controlling the inflammation due to the bacterial biofilm is to prevent its installation and progression. The procedure tested in this study is an air abrasion device, 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 by disorganizing and eliminating the biofilm. Follow-up of the patients will be held every 2 months for 6 months by scoring the bleeding on probing, the plaque index and measuring clinical attachment level in order to compare it with the initial measure. At 6 month an X-ray will also enable to compare bone level and mineralization. This initial study will help establish a standardized protocol for peri-implant infection management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis, Mucositis
Keywords
Mucositis, Peri-Implantitis, Air-Flow Master Piezon®

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Air-polishing device
Arm Type
Experimental
Arm Description
Air polishing of the implant surface and/or elimination of the intrapocket biofilm using the air abrasion device Air-Flow Master Piezon®
Intervention Type
Device
Intervention Name(s)
Air-polishing device
Other Intervention Name(s)
Air-Flow Master Piezon®
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline peri-implant inflammation at 6 months
Description
bleeding on probing (binary criteria : yes/no)
Time Frame
6 months
Title
Change from baseline peri-implant inflammation at 4 months
Description
bleeding on probing (binary criteria : yes/no)
Time Frame
4 months
Title
Change from baseline peri-implant inflammation at 2 months
Description
bleeding on probing (binary criteria : yes/no)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
stability of the bone level
Description
bone level assessed by X-ray
Time Frame
6 months
Title
clinical attachment gain
Description
The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain
Time Frame
2 months
Title
clinical attachment gain
Description
The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain
Time Frame
4 months
Title
clinical attachment gain
Description
The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain
Time Frame
6 months
Title
Quality of life with Oral Health Assessment Tool (OHAT)
Description
The Oral Health Assessment Tool (OHAT) was a component of the Best Practice Oral Health Model for Australian Residential Care study. The OHAT provided institutional carers with a simple, eight category screening tool to assess residents' oral health, including those with dementia
Time Frame
6 months
Title
Quality of life with the Geriatric Oral Health Assessment Index (GOHAI)
Description
The Geriatric Oral Health Assessment Index (GOHAI) is a self-reported measure designed to assess the oral health problems of older adults
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Laurencin, MD
Organizational Affiliation
University Hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse (Faculty of Dental Surgery)
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device

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