Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laser
A laser will be used to clean out the area around the diseased implant to try to regain bone.
Laser
This is a surgery that the patient will undergo and the laser will be used to clean the surface of the implant.
Mechanical
Mechanical debridement will be used to clean out the area around the diseased implant to try to regain bone.
Mechanical debridement
This is a surgery that the patient will undergo to have the surface of the implant cleaned using hand instruments.
Interventions
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Laser
This is a surgery that the patient will undergo and the laser will be used to clean the surface of the implant.
Mechanical debridement
This is a surgery that the patient will undergo to have the surface of the implant cleaned using hand instruments.
Eligibility Criteria
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Inclusion Criteria
* Physical status according to the American Society of Anesthesiologists (ASA) I or II, which includes patients who are systemically healthy or suffer under mild to moderate, but well controlled systemic diseases.
* Patients having a minimum of 1 dental implant with peri-implantitis.
* The dental implant with peri-implantitis has ≥ 3 threads exposed or pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus).
* The implants are in function for at least 6 months
* No uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease.
* Only rough surface implant will be included in this study
Exclusion Criteria
* No peri-implantitis treatment in the last 2 months
* Patients taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, Hormone replacement therapy for menopausal women, Parathyroid hormone, Denosumab, strontium ranelate).
* Pregnant females or those planning to become pregnant.
* Patients with a history of medically diagnosed oral cancer, bisphosphonate usage, Sepsis or those having adverse outcomes to oral procedures in the past, will be excluded
* Mobility of dental implants
* History of alcoholism or drug abuse
* Current smokers or quit smoking less than 6 months
* Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c \>7)
* Patients with allergies known to affect one or more of the treatment provided in this study
* Polish surface implants
* Implants with trabecular surface
18 Years
85 Years
ALL
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Dr Hom-Lay Wang
Principal Investigator
Principal Investigators
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Fernando Suarez, DDS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan School of Dentistry
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00077816
Identifier Type: -
Identifier Source: org_study_id
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