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

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.

Study Overview

• Status: Withdrawn
• Conditions: Mucositis; Peri-Implantitis
• Intervention / Treatment: Device: Air-polishing device

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital Toulouse (Faculty of Dental Surgery)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Air-Flow Master Piezon®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
stability of the bone level	bone level assessed by X-ray	6 months
clinical attachment gain	The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain	2 months
clinical attachment gain	The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain	4 months
clinical attachment gain	The measurement of the probing depth and of the eventual recession (compared to Baseline) allows to assess the clinical attachment gain	6 months
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	6 months
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	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Sara Laurencin, MD, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Mucositis; Peri-Implantitis; Air-Flow Master Piezon®
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Mucositis; Peri-Implantitis
• Other Study ID Numbers: RC31/15/7854; 2016-A00754-47 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No