NCT01972399

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

October 7, 2013

Last Update Submit

April 1, 2015

Conditions

Peri-implantitis

Outcome Measures

Primary Outcomes (1)

  • Perio Probing Depth

    Change in probing depth from beginning of study to 6 months after intervention

Secondary Outcomes (1)

  • Bleeding on Probing

    Change in bleeding on probing from beginning of study to 6 months after intervention

Study Arms (2)

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

LaserPROCEDURE

This is a surgery that the patient will undergo and the laser will be used to clean the surface of the implant.

Laser
Mechanical debridementPROCEDURE

This is a surgery that the patient will undergo to have the surface of the implant cleaned using hand instruments.

Mechanical

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Fernando Suarez, DDS

    University of Michigan

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 30, 2013

Study Start

January 1, 2016

Primary Completion

April 1, 2017

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

US(1)