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Procedure
Air-Polishing vs Ultrasonic Treatment for Gum Inflammation
N/A
Waitlist Available
Led By Hom-Lay Wang, DDS MSD PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 to 85 years
Be older than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Summary
This trial evaluates 2 cleaning instruments to treat peri-implant mucositis, a gum inflammation, using measurements & fluid/plaque samples.
Who is the study for?
This trial is for adults aged 18-85 with good overall health and a dental implant that's been in place for over a year. They must show signs of gum inflammation around the implant but no bone loss, or have healthy implants as part of regular dental care. Excluded are those with poorly controlled diabetes, certain systemic diseases, smokers, pregnant women, long-term users of anti-inflammatories or antibiotics, and those on anticoagulants.
What is being tested?
The study compares two cleaning methods—Air-Polish and Ultrasonic—for treating gum inflammation around dental implants (peri-implant mucositis). Researchers will assess changes in inflammation and bacteria levels by measuring probing depth and analyzing fluid and plaque from around the implant.
What are the potential side effects?
While specific side effects aren't detailed here, typical risks may include discomfort during treatment, temporary increased sensitivity or bleeding in treated areas. These procedures are generally considered safe with minimal side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My diabetes is not well-managed (HbA1c >6.5).
Select...
I do not have diseases like osteoporosis that affect bone health.
Select...
I haven't taken antibiotics for more than a week in the last 3 months.
Select...
I am currently taking blood thinner medications.
Select...
I have been taking anti-inflammatory drugs for the last 3 months.
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I am currently taking corticosteroids.
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I need to take antibiotics to prevent infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 4 weeks, 3 months, and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bleeding on probing scores (Mombelli et al.)
Bone measurement
Gingival index (Loe & Silness)
+3 moreSecondary study objectives
Bacterial DNA levels
Inflammatory cytokines levels
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Peri-mucositisExperimental Treatment2 Interventions
Dental implant has peri-implant mucositis
Group II: HealthyPlacebo Group1 Intervention
Dental implant does not have peri-implant mucositis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasonic
2011
N/A
~140
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,863 Previous Clinical Trials
6,441,521 Total Patients Enrolled
Hom-Lay Wang, DDS MSD PhDPrincipal InvestigatorDepartment of Periodontics and Oral Medicine University of Michigan
7 Previous Clinical Trials
255 Total Patients Enrolled