Therapeutic Peri-implant Maintenance with Laser Therapy

Completed

• Conditions: Peri-Implantitis
• Interventions: Other: Observation

• Registration Number: NCT04251793
• Lead Sponsor: 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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-07-08
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Primary Completion: 2021-06-02
• Study Completion: 2021-06-02
• Status Verified: 2021-07
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard mechanical debridement	Observation	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.
Er:YAG laser-assisted debridement	Observation	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.

Primary Outcome Measures

Name	Time	Method
Change in Periodontal Probing Depths (PD)	Baseline and 6 months	PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change in marginal bone level (MBL)	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.
Change in Clinical Attachment Level (CAL)	Baseline and 6 months	CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 6 months.

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States