Therapeutic Peri-implant Maintenance With Laser Therapy

July 29, 2021 updated by: Chin-Wei Wang, University of Michigan

Therapeutic Peri-implant Maintenance With Laser Therapy: An Extension of the LARST Study

The present study represents an extension of the previously concluded randomized clinical trial "Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis" (HUM00124386). The aim of the study is to compare the adjunctive effect of laser over mechanical debridement alone in the maintenance of peri-implant tissues after surgical treatment of peri-implantitis (gum disease around implants).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The same 24 subjects, previously treated with surgical regenerative treatment of peri-implantitis following the LARST protocol, will be invited to return for three follow-up visits. During the follow-up visits, clinical measurements, x-rays, and pictures of the inside of their mouth will be taken to evaluate the success of their peri-implantitis treatment. If needed, additional laser treatment of the dental implant may also be provided according to the same randomization of subjects in the original study. No placebo laser application will be provided.

Study Type

Observational

Enrollment (Actual)

16

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, 48109
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who previously participated in the Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis study HUM00124386.

Description

Inclusion Criteria:

  • Subjects who were previously enrolled subjects in the randomized clinical trial of laser-assisted regenerative surgical therapy

Exclusion Criteria:

  • Unable to reach the subject
  • The implant is mobile or lost

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Er:YAG laser-assisted debridement
Subjects who were randomly selected to receive debridement and surface detoxification of their implant surface and removal of the inflamed tissue with the aid of the laser treatment two years ago at the Graduate Periodontics Clinic at University of Michigan.
Other: Observation
Soft tissue implant measurements and radiographs
Standard mechanical debridement
Subjects who were randomly selected to receive debridement and surface detoxification of their implant surface and removal of the inflamed tissue with dental scalers two years ago at the Graduate Periodontics Clinic at University of Michigan.
Other: Observation
Soft tissue implant measurements and radiographs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Periodontal Probing Depths (PD)
Time Frame: Baseline and 6 months
PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Attachment Level (CAL)
Time Frame: Baseline and 6 months
CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 6 months.
Baseline and 6 months
Change in marginal bone level (MBL)
Time Frame: Baseline and 6 months
Marginal bone level will be measured compared to baseline. Participants' standardized radiographs will be used to determine bone level changes between baseline and 6 months.
Baseline and 6 months

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: Chin-Wei Wang, DDS, DMSc, Department of Periodontics and Oral Medicine University of Michigan

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)

July 8, 2019

Primary Completion (Actual)

June 2, 2021

Study Completion (Actual)

June 2, 2021

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00160290

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

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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