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

NCT ID: NCT03348111

Last Updated: 2020-08-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2021-06-30

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.

Conditions

Peri-Implantitis; Mucositis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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®

Group Type: EXPERIMENTAL

Air-polishing device

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Air-Flow Master Piezon®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Laurencin, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

University Hospital Toulouse (Faculty of Dental Surgery)

Toulouse, , France

Countries

France

Other Identifiers

2016-A00754-47

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/15/7854

Identifier Type: -

Identifier Source: org_study_id