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Completed

NCT Number: NCT04251793

Therapeutic Peri-implant Maintenance with Laser Therapy

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).

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation

Other

Soft tissue implant measurements and radiographs

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Morita J USA

Registry information

Official study title

Therapeutic Peri-implant Maintenance with Laser Therapy: an Extension of the LARST Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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