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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magdent Cap MED | Experimental | Soft and hard tissue healing with electomagnetic healing abutment. |
|
| Sham MED | Sham Comparator | Soft and hard tissue healing with a regular healing abutment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magdent Cap MED | Device | Magdent is intended to be used for accelaration of soft tissue and bone healing |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadar Zigdon, DMD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus, Dept. of Periodontology | Haifa | 31096 | Israel |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Sham MED | Device | Sham MED is intended to be used for soft tissue healing |
|