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Procedure

Implantoplasty for Peri-Implant Mucositis

N/A
Waitlist Available
Led By Andrea Ravida
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously treated implants must have probing depths (PD) ≤ 4 mm
Patients must have been treated previously for peri-implantitis with or without IP, with at least 1 thread or 2 mm of implant surface exposed in the oral cavity.
Must not have
Patients with congenital or metabolic bone disorders (ie. osteoporosis, vitamin D deficiency, parathyroid disease, etc.)
Subjects with co-morbid conditions (i.e., uncontrolled diabetes, cardiovascular disease, impaired kidney function, heart murmur, rheumatic fever, bleeding disorder, hepatitis, tuberculosis, HIV) that would affect the study outcome or interpretation of study results will be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 21 and 42 days
Awards & highlights

Summary

This trial will compare how well implants treated with/without a procedure heal mouth inflammation.

Who is the study for?
This trial is for adults aged 18-80 in good health, with specific dental implants previously treated for peri-implantitis. Participants should have minimal bacteria on the implant, stable bone levels around it, and healthy gums. Excluded are those with active infections, certain medical conditions requiring premedication before dental visits, pregnant women or those planning pregnancy, heavy smokers, and individuals on significant drug therapy.
What is being tested?
The study aims to compare the healing process of gum inflammation around dental implants (PIM) that were previously smoothed down (IP) versus not. It will look at clinical signs of healing as well as immune response and bacterial changes during the development and resolution of PIM.
What are the potential side effects?
As this trial involves inducing and resolving gum inflammation experimentally around implants rather than testing a medication or device with systemic effects, side effects are expected to be localized to the mouth area such as temporary swelling or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My dental implants have a probing depth of 4 mm or less.
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I have been treated for gum disease around my dental implant, exposing part of it.
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a bone condition like osteoporosis or vitamin D deficiency.
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I do not have any major health issues that could affect the study.
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I do not have any active infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 21 and 42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 21 and 42 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in the modified Gingival Index (mGI) between 21 and 42 days
Secondary study objectives
Changes in probing depth (PD)
Marginal bone loss (MBL)
Microbiological profile of the biofilm analysis
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Implants with history of peri-implantitisExperimental Treatment2 Interventions
Implant(s) treated previously for peri-implantitis with or without exposed polished surface, no PD \> 4 mm and \< 50% bone loss.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,762 Previous Clinical Trials
16,347,973 Total Patients Enrolled
1 Trials studying Peri-Implantitis
150 Patients Enrolled for Peri-Implantitis
Andrea RavidaPrincipal InvestigatorUniversity of Pittsburgh
~0 spots leftby Oct 2024
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