Effect of Static Magnetic Field on Dental Implant Stability. | NCT06226038

Studies
Effect of Static Magnetic Field on Dental Implant Stability.

NCT06226038

Sponsor

Mahidol University

Status

Recruiting

Last Update Posted

May 16, 2024Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Implant Site Reaction

Interventions

Magnet disc
Stainless steel

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jan 17, 2024

First Submission Date that Met QC Criteria

Jan 17, 2024

First Posted Date

Jan 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2024

Last Update Posted Date

May 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the effect of static magnetic field on dental implant to bone integration.

Detailed Description

Bone to implant integration depend on bone healing. Magnetic field was proved to promote and make bone to implant integration happen faster. We decided to investigate by placing 2 dental implants in lower jaw of complete edentulous patients with specialised temporary dentures. Said denture will have neodymium magnet on one side, completely embedded in acrylic mass.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
With magnet	Experimental		Other: Magnet disc
Without magnet	Sham Comparator		Other: Stainless steel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnet disc	Other	Magnetic field promote proliferation and stimulate osteoblast differentiation	With magnet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implant stability quotient	Stability quantity of dental implant measured by resonance frequency analysis machine	90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy, complete edentulous area

Exclusion Criteria:

uncontrolled NCDs patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mahidol university	Recruiting	Bangkok	Payatai	10400	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013193	Stainless Steel

Ancestor Terms

ID	Term
D013232	Steel
D058085	Iron Compounds
D007287	Inorganic Chemicals
D000497	Alloys
D008670

Browse Leaves

Not provided

Browse Branches

Not provided