Clinical trial NCT03348111: Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device
Official title: Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Peri-Implantitis
Mucositis
Keywords: Mucositis
Peri-Implantitis
Air-Flow Master Piezon®
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline peri-implant inflammation at 6 months
timeFrame: 6 months
measure: Change from baseline peri-implant inflammation at 4 months
timeFrame: 4 months
measure: Change from baseline peri-implant inflammation at 2 months
timeFrame: 2 months
Secondary outcomes:
measure: stability of the bone level
timeFrame: 6 months
measure: clinical attachment gain
timeFrame: 2 months
measure: clinical attachment gain
timeFrame: 4 months
measure: clinical attachment gain
timeFrame: 6 months
measure: Quality of life with Oral Health Assessment Tool (OHAT)
timeFrame: 6 months
measure: Quality of life with the Geriatric Oral Health Assessment Index (GOHAI)
timeFrame: 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse (Faculty of Dental Surgery)
Study officials:
affiliation: University Hospital of Toulouse
name: Sara Laurencin, MD
role: PRINCIPAL_INVESTIGATOR
References: