An interventional study of Air-polishing device in Peri-Implantitis and Mucositis, sponsored by University Hospital, Toulouse. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-26.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment
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.
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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Exclusion Criteria:
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
Also known as: Air-Flow Master Piezon®
Change from baseline peri-implant inflammation at 6 months
bleeding on probing (binary criteria : yes/no)
Time frame: 6 months
Change from baseline peri-implant inflammation at 4 months
bleeding on probing (binary criteria : yes/no)
Time frame: 4 months
Change from baseline peri-implant inflammation at 2 months
bleeding on probing (binary criteria : yes/no)
Time frame: 2 months
stability of the bone level
bone level assessed by X-ray
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
Plan to share: No
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This study is withdrawn, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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