Peri-ImplantitisNCT05683405
Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis.
A study testing Non-surgical treatment of peri-implantitis with mechanical debridement and Non-surgical treatment of peri-implantitis with air polishing in people with Peri-Implantitis, run by Tannhelsetjenestens Kompetansesenter for Nord-Norge at 1 site in Norway.
Trial summary
The goal of this clinical trial is to compare non-surgical treatment by mechanical debridement with air-polishing in peri-implantitis. The main question it aims to answer is: Does non-surgical treatment of peri-implantitis with an air-polishing devise (Perioflow® EMS, Nyon Switzerlad) provide a better treatment result… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Non-surgical treatment of peri-implantitis with mechanical debridement and Non-surgical treatment of peri-implantitis with air polishing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred to TkNN (Tannhelsetjenestens kompetansesenter for Nord-Norge) for treatment of peri-implantitis
- Participants should have at least one implants with peri-implantitis according to the diagnostic criteria from the 2017 Chicago Consensus Meeting.
Who cannot join
- Cemented prosthetic reconstructions, individuals smoking more than 10 cigarettes per day, individuals with diabetes and poor control of blood glucose levels, antibiotic treatment during the past threee months, and implants that are preferably to be extracted due to prognosis or function, are excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Tannhelsetjenestens kompetansesenter for Nord-Norge
Tromsø, Troms, 9271
Elin Hadler-Olsen, +4748067249, elin.hadlerolsen@tffk.no
About this study
Official title: Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis: Mechanical Debridement vs. Air-polishing
The goal of this clinical trial is to compare non-surgical treatment by mechanical debridement with air-polishing in peri-implantitis. The main question it aims to answer is:
- Does non-surgical treatment of peri-implantitis with an air-polishing devise (Perioflow® EMS, Nyon Switzerlad) provide a better treatment result than conventional cleaning with mechanical instruments?
Read more
Participants will receive non-surgical treatment of peri-implantitis either with mechanical debridement and with an air-polishing devise.
Researchers will compare pocket depth and bleeding/suppuration on probing in implants treated with the two methods to see if either of them is more efficient in treatment of peri-implantitis.
- Conditions
- Peri-Implantitis
- Being tested
- Non-surgical treatment of peri-implantitis with mechanical debridement, Non-surgical treatment of peri-implantitis with air polishing
- Keywords
- Peri-implantitis, Non-surgical treatment, Air-polishing, Mechanical debridement, Bleeding on probing, periodontal pocket depth
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical treatment of peri-implantitis with mechanical debridementProcedure or surgery
Non-surgical treatment of peri-implantitis with mechanical debridement .
Non-surgical treatment of peri-implantitis with air polishingProcedure or surgery
Non-surgical treatment of peri-implantitis with air polishing
| Study group | Role | What they receive |
|---|---|---|
| Mechanical debridement | Experimental | Not described Receives: Procedure: Non-surgical treatment of peri-implantitis with mechanical debridement |
| Air polishing | Experimental | Not described Receives: Procedure: Non-surgical treatment of peri-implantitis with air polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
Probing depth 5 millimeters or more
Measured: 26 weeks
Bleeding on probing
Bleeding from pocket on pocket depth probing
Measured: 26 weeks
Suppuration on probing
Suppuration from pocket on pocket depth probing
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Aug 2023 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2028 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will be randomized to non-surgical treatment of peri-implantitits with either mechanical debridement or with air-polishing.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tannhelsetjenestens Kompetansesenter for Nord-Norge
- Sponsor type
- University, hospital or other
- Collaborators
- Malmö University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683405
- Sponsor's protocol ID
- 343997
- Status last verified
- May 2023
- First submitted
- 5 Jan 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis: Mechanical Debridement vs. Air-polishing
- ClinicalTrials.gov ID
- NCT05683405
- Acronym / sponsor ID
- 343997
- Conditions
- Peri-Implantitis
- Keywords
- Peri-implantitis, Non-surgical treatment, Air-polishing, Mechanical debridement, Bleeding on probing, periodontal pocket depth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Tannhelsetjenestens Kompetansesenter for Nord-NorgeUniversity, hospital or other
- Collaborators
- Malmö University
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Jan 2023 (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.
The goal of this clinical trial is to compare non-surgical treatment by mechanical debridement with air-polishing in peri-implantitis. The main question it aims to answer is:
- Does non-surgical treatment of peri-implantitis with an air-polishing devise (Perioflow® EMS, Nyon Switzerlad) provide a better treatment result than conventional cleaning with mechanical instruments?
Participants will receive non-surgical treatment of peri-implantitis either with mechanical debridement and with an air-polishing devise.
Researchers will compare pocket depth and bleeding/suppuration on probing in implants treated with the two methods to see if either of them is more efficient in treatment of peri-implantitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will be randomized to non-surgical treatment of peri-implantitits with either mechanical debridement or with air-polishing.
| Arm | Type | Receives |
|---|---|---|
| Mechanical debridement | Experimental | Procedure: Non-surgical treatment of peri-implantitis with mechanical debridement |
| Air polishing | Experimental | Procedure: Non-surgical treatment of peri-implantitis with air polishing |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Referred to TkNN (Tannhelsetjenestens kompetansesenter for Nord-Norge) for treatment of peri-implantitis
- Participants should have at least one implants with peri-implantitis according to the diagnostic criteria from the 2017 Chicago Consensus Meeting.
Key exclusion criteria (1 listed)
- Cemented prosthetic reconstructions, individuals smoking more than 10 cigarettes per day, individuals with diabetes and poor control of blood glucose levels, antibiotic treatment during the past threee months, and implants that are preferably to be extracted due to prognosis or function, are excluded.
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 |
|---|---|---|
| Non-surgical treatment of peri-implantitis with mechanical debridementNon-surgical treatment of peri-implantitis with mechanical debridement . | Procedure or surgery | Mechanical debridement |
| Non-surgical treatment of peri-implantitis with air polishingNon-surgical treatment of peri-implantitis with air polishing | Procedure or surgery | Air polishing |
Primary outcome
Probing depth
Time frame: 26 weeks
Probing depth 5 millimeters or more
Bleeding on probing
Time frame: 26 weeks
Bleeding from pocket on pocket depth probing
Suppuration on probing
Time frame: 26 weeks
Suppuration from pocket on pocket depth probing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical treatment of peri-implantitis with mechanical debridement and Non-surgical treatment of peri-implantitis with air polishing in people with Peri-Implantitis, run by Tannhelsetjenestens Kompetansesenter for Nord-Norge at 1 site in Norway.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Jun 2023. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elin Hadler-Olsen, PhD (+47 48 06 72 49, elin.hadlerolsen@tffk.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: 26 weeks). 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 1 Jun 2023.