Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis

Study Overview
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Brief Summary
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The purpose of the study is to evaluate if using Erbium-doped yttrium aluminium garnet laser, Erbium YAG laser (Er:YAG) laser could have adjunctive benefits to the conventional standard mechanical debridement to ablate the infected tissue around the dental implant and detoxify the contaminated implant surface for resolving peri-implant infection and enhance bone regeneration of peri-implant defects.

Detailed Description
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The purpose of the study is to evaluate if using Er:YAG laser could have adjunctive benefits to the conventional standard mechanical debridement to ablate the infected tissue around the dental implant and detoxify the contaminated implant surface for resolving peri-implant infection and enhance bone regeneration of peri-implant defects. This study involves one center and a double-blinded randomized controlled clinical trial is planned. Twenty-four adult patients in the need of surgical treatment due to peri-implantitis will be included. Six visits are needed for each patient including a 24 week follow-up visit. Specific Aim 1: To compare the clinical benefit of Er:YAG laser-assisted peri-implant defect debridement and surface detoxification with conventional mechanical debridement for regenerative therapy Specific Aim 2: To evaluate whether Er:YAG laser-assisted regenerative surgical therapy can decrease bacterial load and alter microbial profile Specific Aim 3: To analyze whether Er:YAG laser-assisted regenerative surgical therapy can impact the molecular profile of the peri-implant crevicular fluid (PICF) and the stability of the treatment

Official Title
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Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis: A Randomized Controlled Clinical Trial

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Other: Standard mechanical debridement
* Device: Er:YAG laser-assisted debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects, aged 18 - 85 years Physical status according to the American Society of Anesthesiologists (ASA) I or II, which includes patients who are systemically healthy or suffer under mild to moderate, but well controlled systemic diseases. Subjects having a minimum of 1 dental implant with peri-implantitis. Dental implants with peri-implantitis ≥ 2 threads exposed (infrabony defect) identified on the radiograph and pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus) The implants are in function for at least 6 months Only rough surface implant will be included in this study Exclusion Criteria: Long-term use of antibiotics > 2 weeks in the past two months Obvious malpositioning of the dental implants Subjects taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, Hormone replacement therapy for menopausal women, parathyroid hormone, Denosumab, strontium ranelate) Pregnant females or those planning to become pregnant Subjects with a history of major diseases, oral cancer, sepsis or those having adverse outcomes to oral procedures in the past, will be excluded Mobility of dental implants History of alcoholism or drug abuse Current smokers Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c >8) Uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard mechanical debridement<br>Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers. | Other: Standard mechanical debridement<br>* Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy<br>|
| Experimental: Er:YAG laser-assisted debridement<br>Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment. | Other: Standard mechanical debridement<br>* Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy<br>Device: Er:YAG laser-assisted debridement<br>* Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy<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 24 Week | 
| Change in Clinical Attachment Level (CAL) | CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks. | Baseline and 24 Week | 
| Change in Bleeding on Probing (BOP) | BOP will be measured dichotomously as 0 or 1. Score 0=no bleeding present Score 1=bleeding present Change in subject BOP score was calculated between baseline and 24 weeks and reported as percent of sites with BOP. | Baseline and 24 Week | 
| Change in Radiographic Bone Fill (RBF) | Peri-implant bony defect change will be measured compared to baseline. Participants' standardized radiographs were used to determine bone level changes between baseline and 24 weeks. | Baseline and 24 Week | 

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