Status:
COMPLETED
Treatment of Peri-implant Mucositis and Supportive Peri-implant Therapy
Lead Sponsor:
University of Michigan
Conditions:
Peri-implant Mucositis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 on...
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. ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- 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.
- Exclusion criteria:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06137846
Start Date
October 31 2023
End Date
June 20 2025
Last Update
August 24 2025
Active Locations (1)
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1
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109