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WithdrawnNCT01972399Updated Apr 3, 2015

Laser Therapy Treatment of Peri-implantitis.

A Phase 3 interventional study of Laser and Mechanical debridement in Peri-implantitis, sponsored by University of Michigan. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-03.

Sponsored by University of Michigan · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Withdrawn from IRB at PI's request
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Peri-implantitis

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03

In context

Peri-Implantitis

304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.

Browse Peri-Implantitis studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Laser

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

    Procedure: Laser

  • 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

Interventions

  • ProcedureLaser

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

  • ProcedureMechanical debridement

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

06

What researchers measure

Primary outcomes

  1. Perio Probing Depth

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

Secondary outcomes

  1. Bleeding on Probing

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

07

Study locations

1 site
  • University of Michigan School of Dentistry
    Ann Arbor, Michigan 48109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01972399
Lead sponsor
University of Michigan
Responsible party
Dr Hom-Lay Wang (Principal Investigator, University of Michigan) — Principal investigator
First posted
Oct 30, 2013
Start date
Jan 2016
Primary completion
Apr 2017 (estimated)
Last update
Apr 3, 2015

Study contacts

Fernando Suarez, DDS
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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