An interventional study of Magdent Cap MED and Sham MED in Peri-Implantitis, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 20 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment
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.
304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.
This study's enrollment of 23 is below the median of 40 across 182 interventional studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Soft and hard tissue healing with electomagnetic healing abutment.
Device: Magdent Cap MED
Soft and hard tissue healing with a regular healing abutment.
Device: Sham MED
Magdent is intended to be used for accelaration of soft tissue and bone healing
Sham MED is intended to be used for soft tissue healing
Change in the implant probing depth (IPD)
clinical measurement of the depth of the pocket around the implant in 6 sites
Time frame: baseline, 4 weeks, 12 weeks
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
Time frame: baseline, 2 weeks, 4 weeks, 12 weeks
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Rambam Health Care Campus