Evaluate the Influence of Electromagnetic Field as an Adjunctive Non Surgical Treatment in Implant With Peri-implantitis

Study Overview
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Brief Summary
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the aim of the study is to compare between two non-surgical methods of treatment of peri-implantitis by using debridement and placing an healing abutment with electomagnetic field (MED-Magdent Miniaturized Device) in the test group and Sham healing abutment in the control group ( Sham MED).

Detailed Description
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Dental Implants are common alternative for replacement at the time of tooth loss. The two common methods for treatment implant with inflammation include surgical and global non-surgical treatment. The non-surgical treatment includes soft tissue debridement with various tools which including manual, ultrasonic rotators, lasers and delayed release devices. Using an electromagnetic field to induce bony healing in fractures and around implants is being investigated for studies and was found to be effective and safe. The electric field lowers osteoclasts activity, speeds up osteoid construction and stimulates creation blood vessels development. Forty patients who will attend to the department of periodontology at Rambam health care campus, at the School ofpostgraduate Dentistry, which will meet the research criteria, will be recruited. All patients will exhibit a moderate-onset gum infection around one of the implants.

Official Title
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Randomized Double Blind Controlled Prospective Study to Evaluate the Influence of Electromagnetic Field as an Adjunctive Non Surgical Treatment in Implant With Peri-implantitis

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Device: Magdent Cap MED
* Device: Sham MED


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent. Patients of 20 - 85 years. pocket depth of 5-8 mm and bone loss of 3-5mm Patients with fixed prosthodontics Implant with standart width Exclusion Criteria: Heavy smokers (more than 10 cigarettes per day). Pregnant women active periodontal disease Consumption of Non Steroidal Anti Inflammatory drugs

Ages Eligible for Study
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Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magdent Cap MED<br>Soft and hard tissue healing with electomagnetic healing abutment. | Device: Magdent Cap MED<br>* Magdent is intended to be used for accelaration of soft tissue and bone healing<br>|
| Sham Comparator: Sham MED<br>Soft and hard tissue healing with a regular healing abutment. | Device: Sham MED<br>* Sham MED is intended to be used for soft tissue healing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the implant probing depth (IPD) | clinical measurement of the depth of the pocket around the implant in 6 sites | baseline, 4 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changing in the concentration of the RANKL cytokine | Sampling the amount bycollecting gingival fluid with paper pins and examining the amount of the cytokine with ELISA (Enzyme Linked Immunoflorecance assay)asay | baseline, 2 weeks, 4 weeks, 12 weeks |