Laser Therapy Treatment of Peri-implantitis.

April 1, 2015 updated by: Dr Hom-Lay Wang, University of Michigan

Influence of Laser Therapy Upon Surgical Treatment of Peri-implantitis Lesions.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perio Probing Depth
Time Frame: Change in probing depth from beginning of study to 6 months after intervention
Change in probing depth from beginning of study to 6 months after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding on Probing
Time Frame: Change in bleeding on probing from beginning of study to 6 months after intervention
Change in bleeding on probing from beginning of study to 6 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Fernando Suarez, DDS, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 30, 2013

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00077816

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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