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

Peri-Implantitis Clinical Trial

— PERIFLOW  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03348111
• Other study ID #: RC31/15/7854
• Secondary ID: 2016-A00754-47
• Status: Withdrawn
• Phase: N/A
• Start date: June 2019
• Est. completion date: June 2021

Study information

• Verified date: August 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Peri-Implantitis

Intervention

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

Locations

Country	Name	City	State
France	University Hospital Toulouse (Faculty of Dental Surgery)	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline peri-implant inflammation at 6 months	bleeding on probing (binary criteria : yes/no)	6 months
Primary	Change from baseline peri-implant inflammation at 4 months	bleeding on probing (binary criteria : yes/no)	4 months
Primary	Change from baseline peri-implant inflammation at 2 months	bleeding on probing (binary criteria : yes/no)	2 months
Secondary	stability of the bone level	bone level assessed by X-ray	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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