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

NCT ID: NCT04213144

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2022-10-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peri-Implantitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Magdent Cap MED

Soft and hard tissue healing with electomagnetic healing abutment.

Group Type EXPERIMENTAL

Magdent Cap MED

Intervention Type DEVICE

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

Sham MED

Soft and hard tissue healing with a regular healing abutment.

Group Type SHAM_COMPARATOR

Sham MED

Intervention Type DEVICE

Sham MED is intended to be used for soft tissue healing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magdent Cap MED

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

Intervention Type DEVICE

Sham MED

Sham MED is intended to be used for soft tissue healing

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hadar Zigdon MD

Rambam Health Care Campus

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hadar Zigdon, DMD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rambam Health Care Campus, Dept. of Periodontology

Haifa, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0402-19-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Surgical Treatment of Peri-implantitis Defects
NCT06614426 NOT_YET_RECRUITING NA
Air-polishing in the Treatment of Peri-implantitis
NCT04847648 ENROLLING_BY_INVITATION NA
Regenerative Treatment of Peri-implantitis
NCT06153212 ENROLLING_BY_INVITATION NA