Peri-implant MucositisNCT06137846
Treatment of Peri-implant Mucositis and Supportive Peri-implant Therapy
A study testing Air-Polish and Ultrasonic in people with Peri-implant Mucositis, run by University of Michigan at 1 site in United States.
Trial summary
The investigators are evaluating the therapeutic outcomes of two cleaning instruments on treating peri-implant mucositis. Peri-implant mucositis is inflammation around an implant that is limited to only the gum tissue and is characterized by bleeding on probing, pus, and without any evidence of bone loss. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Air-Polish and Ultrasonic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2023to 20 Jun 2025
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years.
- Healthy systemic conditions (American Society of Anesthesiologists classification (ASA) I or II: systemically healthy or suffer from mild to moderate, but well controlled systemic diseases).
- Must have at least one osseointegrated dental implant with the following conditions (Berglundh et al. 2018a).
- At least 12 months since the prosthesis was placed.
- Absence of bone loss beyond crestal bone level changes from initial bone remodeling.
- For implant mucositis subjects: Presence of bleeding and/or suppuration on gentle probing around implant at least 2 sites. Visual inspection demonstrating the presence of peri-implant signs of inflammation.
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- For healthy implant subjects: Absence of bleeding and/or suppuration on gentle probing around implant.
- Have a current (less than 6 months old) x-ray of the affected site
- All participants must be enrolled in a 3 to 6 months maintenance recall program including teeth/implants prophylaxis and supportive periodontal therapy.
Who cannot join
- Poorly controlled diabetes mellitus (HbA1c >6.5).
- Uncontrolled systemic disease or condition known to alter bone metabolism. (e.g. osteoporosis, osteopenia, hyperparathyroidism, Paget's disease)
- Current smokers or vapers.
- Pregnancy or could be pregnant (self-reported), or plan to be pregnant in the next 6 months.
- Long-term (3 months) intake of anti-inflammatory medications (e.g. non-steroidal anti-inflammatory drugs (NSAIDs)) known to affect periodontal status within one month previous to participation in the study.
- Taking corticosteroids.
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- Long-term antibiotic use (> one weeks) within three months previous to participation in the study.
- No history of supragingival scaling or non-surgical therapy at the affected implant site in the last 1 month.
- Taking anticoagulant medications.
- Subjects who require prophylactic antibiotics.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: Treatment of Peri-implant Mucositis and Supportive Peri-implant Therapy Using an Erythritol Air- Polishing Device Versus Conventional Mechanical Debridement: A 6-month Randomized Controlled Clinical Trial
The investigators are evaluating the therapeutic outcomes of two cleaning instruments on treating peri-implant mucositis. Peri-implant mucositis is inflammation around an implant that is limited to only the gum tissue and is characterized by bleeding on probing, pus, and without any evidence of bone loss. The investigators wish to compare the amount of inflammation and bacteria through measurements (like probing depth) and by collecting fluid and plaque samples around participants' implant after using one of the two cleaning instruments.
Read the detailed description
Despite the potential benefits of an air-polishing device with erythritol powder, clinical trials using the device as a monotherapy for treating patients with peri-implant mucositis remained limited. Therefore, the primary aim of the present study is to compare clinical outcomes of the non-surgical treatment of peri-implant mucositis and subsequent supportive peri-implant therapy (SPIT) using an erythritol air-polishing device or conventional mechanical debridement. The secondary aim is to compare the resolution of inflammation after non-surgical treatment of peri-implant mucositis and to monitor levels of peri-implant tissues inflammation during supportive peri-implant therapy by using the level of selected pro-inflammatory cytokines.
Up to 60 participants with dental implants will be recruited from patients seeking and/or receiving dental care at the University of Michigan Graduate Periodontics department, until 34 peri-mucositis participants and 17 healthy participants are achieved.
- Conditions
- Peri-implant Mucositis
- Being tested
- Air-Polish, Ultrasonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-PolishDevice
Dental implant will be cleaned with an airpolishing device
UltrasonicDevice
Dental implant will be cleaned with an ultrasonic device with a plastic tip
| Study group | Role | What they receive |
|---|---|---|
| Peri-mucositis | Experimental | Dental implant has peri-implant mucositis Receives: Device: Air-Polish; Device: Ultrasonic |
| Healthy | Placebo comparator | Dental implant does not have peri-implant mucositis Receives: Device: Air-Polish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth Measurements
To compare probing depth measurements in millimeters after non-surgical treatment of peri-implant mucositis
Measured: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Bleeding on Probing Scores (Mombelli et al.)
To compare bleeding on probing after non-surgical treatment of peri-implant mucositis. Possible scores range from 0 to 3, with higher scores indicating heavier bleeding.
Measured: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Plaque Score (Loe & Silness)
To compare plaque scores after non-surgical treatment of peri-implant mucositis. Possible scores range from 0 to 3, with higher scores indicating greater plaque accumulation.
Measured: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Gingival Index (Loe & Silness)
To compare gingival index scores after non-surgical treatment of peri-implant mucositis. Possible scores range from 0 to 3, with higher scores indicating greater inflammation.
Measured: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Gum Recession Measurement
To compare gum recession after non-surgical treatment of peri-implant mucositis
Measured: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Bone Measurement
Loss of supporting bone measured by standardized radiographs
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (2)
Interleukin-6 Levels
To compare changes in the concentration of interleukin-6 (IL-6) in peri-implant crevicular fluid (PICF).
Measured: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Bacterial DNA Levels
The reported bacterial assessment values are a mix of the entire bacterial load present in the oral cavity. The values in the data table are a composite measure including Aa, Pg, Pi, Tf, and Td. One composite value is reported for each Arm/Group at each time point.
Measured: Baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start31 Oct 2023
- Primary completion19 Mar 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
- Investigators
- Hom-Lay Wang, DDS MSD PhD, Principal investigator, Department of Periodontics and Oral Medicine University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137846
- Sponsor's protocol ID
- HUM00164918
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2023
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes