NCT04213144

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 3, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2022

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

2.6 years

First QC Date

December 25, 2019

Last Update Submit

April 2, 2023

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • changing in the concentration of the RANKL cytokine

    baseline, 2 weeks, 4 weeks, 12 weeks

Study Arms (2)

Magdent Cap MED

EXPERIMENTAL

Soft and hard tissue healing with electomagnetic healing abutment.

Device: Magdent Cap MED

Sham MED

SHAM COMPARATOR

Soft and hard tissue healing with a regular healing abutment.

Device: Sham MED

Interventions

Magdent Cap MEDDEVICE

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

Magdent Cap MED
Sham MEDDEVICE

Sham MED is intended to be used for soft tissue healing

Sham MED

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Heavy smokers (more than 10 cigarettes per day).
  • Pregnant women
  • active periodontal disease
  • Consumption of Non Steroidal Anti Inflammatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus, Dept. of Periodontology

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Hadar Zigdon, DMD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rambam Health Care Campus

Study Record Dates

First Submitted

December 25, 2019

First Posted

December 30, 2019

Study Start

March 3, 2020

Primary Completion

October 19, 2022

Study Completion

October 19, 2022

Last Updated

April 4, 2023

Record last verified: 2023-04

Locations

IL(1)