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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

Tracking Information
First Submitted Date January 30, 2020
First Posted Date February 5, 2020
Last Update Posted Date February 5, 2020
Actual Study Start Date July 8, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 30, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Therapeutic Peri-implant Maintenance With Laser Therapy
Official Title Therapeutic Peri-implant Maintenance With Laser Therapy: An Extension of the LARST Study
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).
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
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects who previously participated in the Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis study HUM00124386.
Condition Peri-Implantitis
Intervention Other: Observation
Soft tissue implant measurements and radiographs
Study Groups/Cohorts
  • 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.
    Intervention: Other: Observation
  • 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.
    Intervention: Other: Observation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: January 30, 2020)
24
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04251793
Other Study ID Numbers HUM00160290
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Chin-Wei Wang, University of Michigan
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
PRS Account University of Michigan
Verification Date January 2020