Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis

October 31, 2019 updated by: Chin-Wei Wang, University of Michigan

Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis: A Randomized Controlled Clinical Trial

The purpose of the study is to evaluate if using Erbium-doped yttrium aluminium garnet laser, Erbium YAG laser (Er:YAG) laser could have adjunctive benefits to the conventional standard mechanical debridement to ablate the infected tissue around the dental implant and detoxify the contaminated implant surface for resolving peri-implant infection and enhance bone regeneration of peri-implant defects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to evaluate if using Er:YAG laser could have adjunctive benefits to the conventional standard mechanical debridement to ablate the infected tissue around the dental implant and detoxify the contaminated implant surface for resolving peri-implant infection and enhance bone regeneration of peri-implant defects.

This study involves one center and a double-blinded randomized controlled clinical trial is planned. Twenty-four adult patients in the need of surgical treatment due to peri-implantitis will be included. Six visits are needed for each patient including a 24 week follow-up visit.

Specific Aim 1: To compare the clinical benefit of Er:YAG laser-assisted peri-implant defect debridement and surface detoxification with conventional mechanical debridement for regenerative therapy

Specific Aim 2: To evaluate whether Er:YAG laser-assisted regenerative surgical therapy can decrease bacterial load and alter microbial profile

Specific Aim 3: To analyze whether Er:YAG laser-assisted regenerative surgical therapy can impact the molecular profile of the peri-implant crevicular fluid (PICF) and the stability of the treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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, 48104
        • 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:

  • Subjects, 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.
  • Subjects having a minimum of 1 dental implant with peri-implantitis.
  • Dental implants with peri-implantitis ≥ 2 threads exposed (infrabony defect) identified on the radiograph and pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus)
  • The implants are in function for at least 6 months
  • Only rough surface implant will be included in this study

Exclusion Criteria:

  • Long-term use of antibiotics > 2 weeks in the past two months
  • Obvious malpositioning of the dental implants
  • Subjects 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
  • Subjects with a history of major diseases, oral cancer, 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
  • Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c >8)
  • Uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease

Premature Exclusion Criteria:

  • The researcher believes that it is not the best interest of the subject to stay in the study
  • If the subject becomes ineligible to participate based on the exclusion criteria
  • If the subject's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc)
  • If the subject does not follow study related instructions
  • The study is suspended or canceled.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard mechanical debridement
Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.
Other: Standard mechanical debridement
Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy
Experimental: Er:YAG laser-assisted debridement
Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.
Other: Standard mechanical debridement
Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy
Device: Er:YAG laser-assisted debridement
Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Periodontal Probing Depths (PD)
Time Frame: Baseline and 24 Week
PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.
Baseline and 24 Week
Change in Clinical Attachment Level (CAL)
Time Frame: Baseline and 24 Week
CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.
Baseline and 24 Week
Change in Bleeding on Probing (BOP)
Time Frame: Baseline and 24 Week
BOP will be measured dichotomously as 0 or 1. Score 0=no bleeding present Score 1=bleeding present Change in subject BOP score was calculated between baseline and 24 weeks and reported as percent of sites with BOP.
Baseline and 24 Week
Change in Radiographic Bone Fill (RBF)
Time Frame: Baseline and 24 Week
Peri-implant bony defect change will be measured compared to baseline. Participants' standardized radiographs were used to determine bone level changes between baseline and 24 weeks.
Baseline and 24 Week

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

Morita J USA

Investigators

  • Principal Investigator: Jeff (Chin-Wei) Wang, DDS, DMSc, Department of Periodontics and Oral Medicine University of Michigan School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 26, 2017

Primary Completion (Actual)

November 2, 2018

Study Completion (Actual)

November 2, 2018

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 23, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00124386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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