Peri-implant MucositisMechTreatPiMNCT05664425
Mechanical Treatment Peri-Implant Mucositis
A study testing Ultrasonic debridement in people with Peri-implant Mucositis, run by University of Oslo at 1 site in Norway.
Trial summary
This two-arm, single-blinded, monocentric, controlled, randomised clinical study is designed to examine the effect of professional submucosal treatment by means of ultrasonics with plastic tip (test group), as compared to no professional submucosal instrumentation (control group), in the treatment of peri-implant… Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Ultrasonic debridement
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2023to 25 Feb 2025
- 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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be ≥ 20 years
- Subject must have one implant presenting PIM as defined according to the World Workshop 2017 criteria (presence of BoP and/or suppuration (SoP), without bone loss exceeding 0.5 mm beyond crestal bone level changes resulting from initial remodeling, regardless of PPD. In absence of baseline radiographs (i.e., 0-1 year after loading) a bone level of <2mm from the top of the intraosseous part of the implant is considered as the reference threshold)
- Cleansable prosthesis (an interproximal brush must be able to pass from side to side at interproximal aspects tangential to the peri-implant sulcus, and a brush has to be able to reach the buccal and palatal/lingual sulcus).
- No evidence of occlusal overload
- No cement remnants identified on radiographs or clinically
- Implant-supported fixed restoration inserted at least 6 months before patient enrolment and not interfering with assessment of clinical parameters at more than 3/6 sites
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- Periodontally healthy subjects or treated periodontitis (no residual site with PPD ≥ 5 mm)
- Full-mouth plaque (FMPS) and bleeding (FMBS) score ≤ 20%¬¬¬¬¬¬¬ at screening visit
- Non-smokers or light-smokers (<10 cigarettes per day)
- Competent to give consent
Who cannot join
- Previous radiotherapy, current use of chemotherapy, systemic long-term corticosteroid treatment
- Hematologic disorders
- Pregnant subjects
- Patients classified as > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
- No systemic antibiotic treatment within 3 months prior to intervention
Trial locations and contacts
1 site in 1 country.
Norway1 site
Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
Oslo, 0455
About this study
Official title: Mechanical Treatment of Peri-Implant Mucositis -the Effect of Submucosal Instrumentation
This two-arm, single-blinded, monocentric, controlled, randomised clinical study is designed to examine the effect of professional submucosal treatment by means of ultrasonics with plastic tip (test group), as compared to no professional submucosal instrumentation (control group), in the treatment of peri-implant mucositis (PIM). Both groups will have oral hygiene instruction/reinforcement (OHI) at baseline and repeated at 3 months. In the study, 50 participants will be enrolled (25 per group), with each patient contributing one implant with PIM. Peri-implant sulcus fluid (PISF) samples will be obtained at baseline, 3- and 6-months to analyse the change of relevant biomarkers over the course of PIM treatment. Intraoral scans will be performed at baseline, 3- and 6-months to analyse potential soft-tissue volumetric changes according to treatment.
- Conditions
- Peri-implant Mucositis
- Being tested
- Ultrasonic debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic debridementDevice
Ultrasonic debridement with a plastic/teflon tip (2 minutes + 1 minute irrigation)
| Study group | Role | What they receive |
|---|---|---|
| Mechanical treatment arm + oral hygiene reinforcement | Experimental | Subjects receive oral hygiene reinforcement, and additionally submucosal instrumentation with ultrasonics with a plastic tip. Receives: Device: Ultrasonic debridement |
| Oral hygiene reinforcement alone | No intervention | Subjects receive oral hygiene reinforcement, but do not receive submucosal instrumentation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing (BoP) extent
Reduction in the extent of BoP as measured on six sites per implant
Measured: 6 months
Secondary outcomes (7)
Peri-implant sulcus fluid (PISF) biomarkers
Biomarkers sampled at baseline, 3- and 6-months
Measured: 6 months
Intraoral digital scan
Volumetric change of soft tissue following peri-implant mucositis treatment
Measured: 6 months
Disease resolution
No BoP at any of the six probed sites at 6-month follow-up
Measured: 6 months
Severity of BoP
Reduction in the severity of BoP (graded from 0-3) at 6 months
Measured: 6 months
Probing pocket depth (PPD) reduction
Reduction in PPD at 6 months
Measured: 6 months
Bone level changes
Changes in bone level as assessed by radiographs at baseline and 6-months
Measured: 6 months
Onset of peri-implantitis
If peri-implantitis is diagnosed during or following the study, this will be reported. Peri-implantitis is defined as progressive bone loss identified by an increase of PPD changes or bone level changes.
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 posted23 Dec 2022
- Study start1 Mar 2023
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies 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
- Parallell group two-arm randomised study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Verket, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664425
- Sponsor's protocol ID
- MechTreatPiM
- Acronym
- MechTreatPiM
- Status last verified
- Mar 2025
- First submitted
- 8 Dec 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available for other researchers upon reasonable request and as long as in accordance with ethical committee and national GDPR rules.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Treatment of Peri-Implant Mucositis -the Effect of Submucosal Instrumentation
- ClinicalTrials.gov ID
- NCT05664425
- Acronym / sponsor ID
- MechTreatPiM / MechTreatPiM
- Conditions
- Peri-implant Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 23 Dec 2022 (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.
This two-arm, single-blinded, monocentric, controlled, randomised clinical study is designed to examine the effect of professional submucosal treatment by means of ultrasonics with plastic tip (test group), as compared to no professional submucosal instrumentation (control group), in the treatment of peri-implant mucositis (PIM). Both groups will have oral hygiene instruction/reinforcement (OHI) at baseline and repeated at 3 months. In the study, 50 participants will be enrolled (25 per group), with each patient contributing one implant with PIM. Peri-implant sulcus fluid (PISF) samples will be obtained at baseline, 3- and 6-months to analyse the change of relevant biomarkers over the course of PIM treatment. Intraoral scans will be performed at baseline, 3- and 6-months to analyse potential soft-tissue volumetric changes according to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallell group two-arm randomised study
| Arm | Type | Receives |
|---|---|---|
| Mechanical treatment arm + oral hygiene reinforcement | Experimental | Device: Ultrasonic debridementSubjects receive oral hygiene reinforcement, and additionally submucosal instrumentation with ultrasonics with a plastic tip. |
| Oral hygiene reinforcement alone | No intervention | –Subjects receive oral hygiene reinforcement, but do not receive submucosal instrumentation. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must be ≥ 20 years
- Subject must have one implant presenting PIM as defined according to the World Workshop 2017 criteria (presence of BoP and/or suppuration (SoP), without bone loss exceeding 0.5 mm beyond crestal bone level changes resulting from initial remodeling, regardless of PPD. In absence of baseline radiographs (i.e., 0-1 year after loading) a bone level of <2mm from the top of the intraosseous part of the implant is considered as the reference threshold)
- Cleansable prosthesis (an interproximal brush must be able to pass from side to side at interproximal aspects tangential to the peri-implant sulcus, and a brush has to be able to reach the buccal and palatal/lingual sulcus).
- No evidence of occlusal overload
- No cement remnants identified on radiographs or clinically
Key exclusion criteria (5 listed)
- Previous radiotherapy, current use of chemotherapy, systemic long-term corticosteroid treatment
- Hematologic disorders
- Pregnant subjects
- Patients classified as > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
- No systemic antibiotic treatment within 3 months prior to intervention
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 |
|---|---|---|
| Ultrasonic debridementUltrasonic debridement with a plastic/teflon tip (2 minutes + 1 minute irrigation) | Device | Mechanical treatment arm + oral hygiene reinforcement |
Primary outcome
Bleeding on probing (BoP) extent
Time frame: 6 months
Reduction in the extent of BoP as measured on six sites per implant
7 secondary outcomes
Peri-implant sulcus fluid (PISF) biomarkers
Time frame: 6 months
Intraoral digital scan
Time frame: 6 months
Disease resolution
Time frame: 6 months
Severity of BoP
Time frame: 6 months
Probing pocket depth (PPD) reduction
Time frame: 6 months
Bone level changes
Time frame: 6 months
Onset of peri-implantitis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No. IPD will be available for other researchers upon reasonable request and as long as in accordance with ethical committee and national GDPR rules.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic debridement in people with Peri-implant Mucositis, run by University of Oslo 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 7 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bleeding on probing (BoP) extent (time frame: 6 months). 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 7 Mar 2025.