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Laser Therapy Treatment of Peri-implantitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01972399
Recruitment Status : Withdrawn (Withdrawn from IRB at PI's request)
First Posted : October 30, 2013
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Hom-Lay Wang, University of Michigan

Brief Summary:
The primary objective of this study is to compare the clinical outcomes of using Er: YAG laser along with bone graft and barrier membrane to conventional mechanical debridement also with bone graft and barrier membrane in the treatment of peri-implantitis infections.

Condition or disease Intervention/treatment Phase
Peri-implantitis Procedure: Laser Procedure: Mechanical debridement Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Laser Therapy Upon Surgical Treatment of Peri-implantitis Lesions.
Study Start Date : January 2016
Estimated Primary Completion Date : April 2017

Arm Intervention/treatment
Experimental: Laser
A laser will be used to clean out the area around the diseased implant to try to regain bone.
Procedure: Laser
This is a surgery that the patient will undergo and the laser will be used to clean the surface of the implant.

Active Comparator: Mechanical
Mechanical debridement will be used to clean out the area around the diseased implant to try to regain bone.
Procedure: Mechanical debridement
This is a surgery that the patient will undergo to have the surface of the implant cleaned using hand instruments.




Primary Outcome Measures :
  1. Perio Probing Depth [ Time Frame: Change in probing depth from beginning of study to 6 months after intervention ]

Secondary Outcome Measures :
  1. Bleeding on Probing [ Time Frame: Change in bleeding on probing from beginning of study to 6 months after intervention ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients, aged 18 - 85 years
  • 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:

  • Long-term use of antibiotics > 2 weeks in the past two months
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972399


Locations
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United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Fernando Suarez, DDS University of Michigan

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Responsible Party: Dr Hom-Lay Wang, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01972399     History of Changes
Other Study ID Numbers: HUM00077816
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases