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

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ClinicalTrials.gov Identifier: NCT03348111
Recruitment Status : Withdrawn (No participant enrolled)
First Posted : November 20, 2017
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment Phase
Peri-Implantitis Mucositis Device: Air-polishing device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Air-polishing device
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
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
Other Name: Air-Flow Master Piezon®




Primary Outcome Measures :
  1. Change from baseline peri-implant inflammation at 6 months [ Time Frame: 6 months ]
    bleeding on probing (binary criteria : yes/no)

  2. Change from baseline peri-implant inflammation at 4 months [ Time Frame: 4 months ]
    bleeding on probing (binary criteria : yes/no)

  3. Change from baseline peri-implant inflammation at 2 months [ Time Frame: 2 months ]
    bleeding on probing (binary criteria : yes/no)


Secondary Outcome Measures :
  1. stability of the bone level [ Time Frame: 6 months ]
    bone level assessed by X-ray

  2. clinical attachment gain [ Time Frame: 2 months ]
    The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain

  3. clinical attachment gain [ Time Frame: 4 months ]
    The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain

  4. clinical attachment gain [ Time Frame: 6 months ]
    The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain

  5. Quality of life with Oral Health Assessment Tool (OHAT) [ Time Frame: 6 months ]
    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

  6. Quality of life with the Geriatric Oral Health Assessment Index (GOHAI) [ Time Frame: 6 months ]
    The Geriatric Oral Health Assessment Index (GOHAI) is a self-reported measure designed to assess the oral health problems of older adults



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348111


Locations
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France
University Hospital Toulouse (Faculty of Dental Surgery)
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Sara Laurencin, MD University Hospital of Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03348111    
Other Study ID Numbers: RC31/15/7854
2016-A00754-47 ( Other Identifier: ID-RCB )
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Mucositis
Peri-Implantitis
Air-Flow Master Piezon®
Additional relevant MeSH terms:
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Mucositis
Peri-Implantitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases