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Clinical Trials/NCT04213144
NCT04213144
Completed
Not Applicable

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

Rambam Health Care Campus1 site in 1 country23 target enrollmentMarch 3, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-Implantitis
Sponsor
Rambam Health Care Campus
Enrollment
23
Locations
1
Primary Endpoint
Change in the implant probing depth (IPD)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2020
End Date
October 19, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hadar Zigdon MD

Rambam Health Care Campus

Rambam Health Care Campus

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in the implant probing depth (IPD)

Time Frame: baseline, 4 weeks, 12 weeks

clinical measurement of the depth of the pocket around the implant in 6 sites

Secondary Outcomes

  • changing in the concentration of the RANKL cytokine(baseline, 2 weeks, 4 weeks, 12 weeks)

Study Sites (1)

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