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Therapeutic Peri-implant Maintenance With Laser Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251793
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Morita J USA
Information provided by (Responsible Party):
Chin-Wei Wang, University of Michigan

Brief Summary:
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).

Condition or disease Intervention/treatment
Peri-Implantitis Other: Observation

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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Therapeutic Peri-implant Maintenance With Laser Therapy: An Extension of the LARST Study
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251793


Locations
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United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Morita J USA
Investigators
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Principal Investigator: Chin-Wei Wang, DDS, DMSc Department of Periodontics and Oral Medicine University of Michigan
Publications:

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Responsible Party: Chin-Wei Wang, Clinical Assistant Professor of Dentistry, University of Michigan
ClinicalTrials.gov Identifier: NCT04251793    
Other Study ID Numbers: HUM00160290
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chin-Wei Wang, University of Michigan:
Laser
Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases