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

Rambam Health Care Campus

Status: Completed

Conditions: Peri-Implantitis

Treatments: Device: Sham MED; Device: Magdent Cap MED

Study type: Interventional

Funder types: Other

Identifiers

NCT04213144

0402-19-RMB CTIL

Details and patient eligibility

About

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).

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

Magdent Cap MED

Experimental group

Description:

Soft and hard tissue healing with electomagnetic healing abutment.

Treatment:

Device: Magdent Cap MED

Sham MED

Sham Comparator group

Description:

Soft and hard tissue healing with a regular healing abutment.

Treatment:

Device: Sham MED