Laser Therapy Treatment of Peri-implantitis. | NCT01972399

Studies
Laser Therapy Treatment of Peri-implantitis.

NCT01972399

Sponsor

University of Michigan

Status

Withdrawn

Last Update Posted

Apr 3, 2015Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Peri-implantitis

Interventions

Laser
Mechanical debridement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Withdrawn from IRB at PI's request

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Apr 2017Estimated

Completion Date

Not provided

First Submitted Date

Oct 7, 2013

First Submission Date that Met QC Criteria

Oct 24, 2013

First Posted Date

Oct 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2015

Last Update Posted Date

Apr 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser	Experimental	A laser will be used to clean out the area around the diseased implant to try to regain bone.	Procedure: Laser
Mechanical	Active Comparator	Mechanical debridement will be used to clean out the area around the diseased implant to try to regain bone.	Procedure: Mechanical debridement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser	Procedure	This is a surgery that the patient will undergo and the laser will be used to clean the surface of the implant.	Laser

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

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies