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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213144
• Other study ID #: 0402-19-RMB CTIL
• Status: Completed
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: October 19, 2022

Study information

• Verified date: April 2023
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 19, 2022
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Device:
• Magdent Cap MED
Magdent is intended to be used for accelaration of soft tissue and bone healing
• Sham MED
Sham MED is intended to be used for soft tissue healing

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus, Dept. of Periodontology	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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