Peri-ImplantitisPERIFLOWNCT03348111
Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device
A study testing Air-polishing device in people with Peri-Implantitis and Mucositis, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis, Mucositis
- What is being tested?
- Air-polishing device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2019to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Toulouse (Faculty of Dental Surgery)
Toulouse, 31059
About this study
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.
Read the 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
- Being tested
- Air-polishing device
- Keywords
- Mucositis, Peri-Implantitis, Air-Flow Master Piezon®
- Medical subject headings
- Peri-Implantitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-polishing deviceDevice
Also called Air-Flow Master Piezon®
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
| Study group | Role | What they receive |
|---|---|---|
| Air-polishing device | Experimental | Air polishing of the implant surface and/or elimination of the intrapocket biofilm using the air abrasion device Air-Flow Master Piezon® Receives: Device: Air-polishing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline peri-implant inflammation at 6 months
bleeding on probing (binary criteria : yes/no)
Measured: 6 months
Change from baseline peri-implant inflammation at 4 months
bleeding on probing (binary criteria : yes/no)
Measured: 4 months
Change from baseline peri-implant inflammation at 2 months
bleeding on probing (binary criteria : yes/no)
Measured: 2 months
Secondary outcomes (6)
stability of the bone level
bone level assessed by X-ray
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study startJun 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: No participant enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Laurencin, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348111
- Sponsor's protocol ID
- RC31/15/7854
- Other IDs
- 2016-A00754-47
- Acronym
- PERIFLOW
- Status last verified
- Aug 2020
- First submitted
- 30 Oct 2017
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device
- ClinicalTrials.gov ID
- NCT03348111
- Acronym / sponsor ID
- PERIFLOW / RC31/15/7854
- Conditions
- Peri-Implantitis, Mucositis
- Keywords
- Mucositis, Peri-Implantitis, Air-Flow Master Piezon®
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participant enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Air-polishing device | Experimental | Device: Air-polishing deviceAir polishing of the implant surface and/or elimination of the intrapocket biofilm using the air abrasion device Air-Flow Master Piezon® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air-polishing deviceAlso: Air-Flow Master Piezon®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 | Device | Air-polishing device |
Primary outcome
Change from baseline peri-implant inflammation at 6 months
Time frame: 6 months
bleeding on probing (binary criteria : yes/no)
Change from baseline peri-implant inflammation at 4 months
Time frame: 4 months
bleeding on probing (binary criteria : yes/no)
Change from baseline peri-implant inflammation at 2 months
Time frame: 2 months
bleeding on probing (binary criteria : yes/no)
6 secondary outcomes
stability of the bone level
Time frame: 6 months
clinical attachment gain
Time frame: 2 months
clinical attachment gain
Time frame: 4 months
clinical attachment gain
Time frame: 6 months
Quality of life with Oral Health Assessment Tool (OHAT)
Time frame: 6 months
Quality of life with the Geriatric Oral Health Assessment Index (GOHAI)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Laurencin, MD principal investigator
University Hospital of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air-polishing device in people with Peri-Implantitis and Mucositis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline peri-implant inflammation at 6 months (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.