Clinical trial NCT04251793: Therapeutic Peri-implant Maintenance with Laser Therapy
Official title: Therapeutic Peri-implant Maintenance with Laser Therapy: an Extension of the LARST Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-Implantitis
Keywords: Laser
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Morita J USA
First posted: 2020-02-05
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who previously participated in the Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis study HUM00124386.

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.

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.

Primary outcomes:
measure: Change in Periodontal Probing Depths (PD)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Clinical Attachment Level (CAL)
timeFrame: Baseline and 6 months
measure: Change in marginal bone level (MBL)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: Department of Periodontics and Oral Medicine University of Michigan
name: Chin-Wei Wang, DDS, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
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