Evaluate the Influence of Electromagnetic Field as an Adjunctive Non Surgical Treatment in Implant With Peri-implantitis
Primary Purpose
Peri-Implantitis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Magdent Cap MED
Sham MED
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis
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
Sites / Locations
- Rambam Health Care Campus, Dept. of Periodontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Magdent Cap MED
Sham MED
Arm Description
Soft and hard tissue healing with electomagnetic healing abutment.
Soft and hard tissue healing with a regular healing abutment.
Outcomes
Primary Outcome Measures
Change in the implant probing depth (IPD)
clinical measurement of the depth of the pocket around the implant in 6 sites
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04213144
First Posted
December 25, 2019
Last Updated
April 2, 2023
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT04213144
Brief Title
Evaluate the Influence of Electromagnetic Field as an Adjunctive Non Surgical Treatment in Implant With Peri-implantitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magdent Cap MED
Arm Type
Experimental
Arm Description
Soft and hard tissue healing with electomagnetic healing abutment.
Arm Title
Sham MED
Arm Type
Sham Comparator
Arm Description
Soft and hard tissue healing with a regular healing abutment.
Intervention Type
Device
Intervention Name(s)
Magdent Cap MED
Intervention Description
Magdent is intended to be used for accelaration of soft tissue and bone healing
Intervention Type
Device
Intervention Name(s)
Sham MED
Intervention Description
Sham MED is intended to be used for soft tissue healing
Primary Outcome Measure Information:
Title
Change in the implant probing depth (IPD)
Description
clinical measurement of the depth of the pocket around the implant in 6 sites
Time Frame
baseline, 4 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
changing in the concentration of the RANKL cytokine
Description
Sampling the amount bycollecting gingival fluid with paper pins and examining the amount of the cytokine with ELISA (Enzyme Linked Immunoflorecance assay)asay
Time Frame
baseline, 2 weeks, 4 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Zigdon, DMD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus, Dept. of Periodontology
City
Haifa
ZIP/Postal Code
31096
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Influence of Electromagnetic Field as an Adjunctive Non Surgical Treatment in Implant With Peri-implantitis
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