Laser Therapy Treatment of Peri-implantitis.

Study Overview
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Brief Summary
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The primary objective of this study is to compare the clinical outcomes of using Er: YAG laser along with bone graft and barrier membrane to conventional mechanical debridement also with bone graft and barrier membrane in the treatment of peri-implantitis infections.

Official Title
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Influence of Laser Therapy Upon Surgical Treatment of Peri-implantitis Lesions.

Conditions
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Peri-implantitis

Intervention / Treatment
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* Procedure: Laser
* Procedure: Mechanical debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, 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. Patients having a minimum of 1 dental implant with peri-implantitis. The dental implant with peri-implantitis has ≥ 3 threads exposed or pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus). The implants are in function for at least 6 months No uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease. Only rough surface implant will be included in this study Exclusion Criteria: Long-term use of antibiotics > 2 weeks in the past two months No peri-implantitis treatment in the last 2 months Patients 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. Patients with a history of medically diagnosed oral cancer, bisphosphonate usage, 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 or quit smoking less than 6 months Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c >7) Patients with allergies known to affect one or more of the treatment provided in this study Polish surface implants Implants with trabecular surface

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br>A laser will be used to clean out the area around the diseased implant to try to regain bone. | Procedure: Laser<br>* This is a surgery that the patient will undergo and the laser will be used to clean the surface of the implant.<br>|
| Active Comparator: Mechanical<br>Mechanical debridement will be used to clean out the area around the diseased implant to try to regain bone. | Procedure: Mechanical debridement<br>* This is a surgery that the patient will undergo to have the surface of the implant cleaned using hand instruments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perio Probing Depth |  | Change in probing depth from beginning of study to 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on Probing |  | Change in bleeding on probing from beginning of study to 6 months after intervention |