Therapeutic Peri-implant Maintenance With Laser Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Therapeutic Peri-implant Maintenance With Laser Therapy: An Extension of the LARST Study

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Er:YAG laser-assisted debridement<br>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<br>* Soft tissue implant measurements and radiographs<br>|
| Standard mechanical debridement<br>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<br>* Soft tissue implant measurements and radiographs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Periodontal Probing Depths (PD) | PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Attachment Level (CAL) | CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 6 months. | Baseline and 6 months | 
| Change in marginal bone level (MBL) | 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. | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser