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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04213144
Enrollment
23
Registered
2019-12-30
Start date
2020-03-03
Completion date
2022-10-19
Last updated
2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis

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.

Interventions

DEVICEMagdent Cap MED

Magdent is intended to be used for accelaration of soft tissue and bone healing

DEVICESham MED

Sham MED is intended to be used for soft tissue healing

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the implant probing depth (IPD)baseline, 4 weeks, 12 weeksclinical measurement of the depth of the pocket around the implant in 6 sites

Secondary

MeasureTime frameDescription
changing in the concentration of the RANKL cytokinebaseline, 2 weeks, 4 weeks, 12 weeksSampling the amount bycollecting gingival fluid with paper pins and examining the amount of the cytokine with ELISA (Enzyme Linked Immunoflorecance assay)asay

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026