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Laser Therapy Treatment of Peri-implantitis.

Primary Purpose

Peri-implantitis

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Laser
Mechanical debridement
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implantitis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser

Mechanical

Arm Description

A laser will be used to clean out the area around the diseased implant to try to regain bone.

Mechanical debridement will be used to clean out the area around the diseased implant to try to regain bone.

Outcomes

Primary Outcome Measures

Perio Probing Depth

Secondary Outcome Measures

Bleeding on Probing

Full Information

First Posted
October 7, 2013
Last Updated
April 1, 2015
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01972399
Brief Title
Laser Therapy Treatment of Peri-implantitis.
Official Title
Influence of Laser Therapy Upon Surgical Treatment of Peri-implantitis Lesions.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn from IRB at PI's request
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implantitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser
Arm Type
Experimental
Arm Description
A laser will be used to clean out the area around the diseased implant to try to regain bone.
Arm Title
Mechanical
Arm Type
Active Comparator
Arm Description
Mechanical debridement will be used to clean out the area around the diseased implant to try to regain bone.
Intervention Type
Procedure
Intervention Name(s)
Laser
Intervention Description
This is a surgery that the patient will undergo and the laser will be used to clean the surface of the implant.
Intervention Type
Procedure
Intervention Name(s)
Mechanical debridement
Intervention Description
This is a surgery that the patient will undergo to have the surface of the implant cleaned using hand instruments.
Primary Outcome Measure Information:
Title
Perio Probing Depth
Time Frame
Change in probing depth from beginning of study to 6 months after intervention
Secondary Outcome Measure Information:
Title
Bleeding on Probing
Time Frame
Change in bleeding on probing from beginning of study to 6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Suarez, DDS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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Laser Therapy Treatment of Peri-implantitis.

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