| CTRI Number |
CTRI/2025/03/082021 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Checking the effect of magnetic field on dental implant stability. |
|
Scientific Title of Study
|
Evaluation and comparison of the effects of static magnetic field on the stability and osseointegration of the dental implants: An in-vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Paritosh Ware |
| Designation |
Post Graduate |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Coorg Institute of Dental Sciences
Department of Prosthodontics and Crown and Bridge Room number 5
K K Campus Maggula Village
Virajpet
Coorg District
Karnataka
571218
Kodagu
KARNATAKA
571218
India |
| Phone |
7619487167 |
| Fax |
|
| Email |
wareparitosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Arundati N Raj |
| Designation |
Professor |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Coorg Institute of Dental Sciences
Department of Prosthodontics and Crown and Bridge Room number 5
K K Campus Maggula Village
Virajpet
Coorg District
Karnataka
571218
Kodagu
KARNATAKA
571218
India |
| Phone |
7259456315 |
| Fax |
|
| Email |
arundati.raj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Paritosh Ware |
| Designation |
Post Graduate |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Coorg Institute of Dental Sciences
Department of Prosthodontics and Crown and Bridge Room number 5
K K Campus Maggula Village
Virajpet
Coorg District
Karnataka
571218
Kodagu
KARNATAKA
571218
India |
| Phone |
7619487167 |
| Fax |
|
| Email |
wareparitosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg Institute of Dental Sciences
Department of Prosthodontics and Crown and Bridge
Room number 5
K K Campus Maggula Village
Virajpet
Coorg District
Karnataka
571218 |
|
|
Primary Sponsor
|
| Name |
Paritosh Ware |
| Address |
Coorg Institute of Dental Sciences Department of Prosthodontics and Crown and Bridge Room number 5
K K Campus Maggula Village
Virajpet
Coorg District
Karnataka
571218 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raviraj Joshi |
Coorg Institute of Dental Sciences |
Coorg Institute of Dental Sciences Department of Prosthodontics and Crown and Bridge Room number 5
K K Campus Maggula Village
Virajpet
Coorg District
Karnataka
571218
Kodagu
KARNATAKA |
7975005118
ravirajjoshi7212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONL REVIEW BOARD, COORG INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Implant |
Readings of Implant Stability Quotient of implant placed on magnetic side will compared to readings of implant of control group at day 0,30,60,90. |
| Intervention |
Magnet |
A Neodymium boron iron magnet will be a placed over one of the two implants in the edentulous patient for a duration of 3 months. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with completely edentulous mandibular and maxillary jaws with no history of pathology of jaws and systemic diseases. |
|
| ExclusionCriteria |
| Details |
Those patients who are addicted to alcohol or drugs, or have a daily smoking habit or those who have undergone or undergoing chemotherapy or radiation therapy to the head and neck region and those who are on any medication that might compromise healing or osseointegration process. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The stability of implants which are exposed to magnetic field will be higher in values in terms of Implant Stability Quotient compared to those not exposed to magnetic field at various time intervals. |
Measurements will be done using Resonance Frequency Analyser in terms of Implant Stability Qutient value at day 0,30,60,90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The static magnetic field created by using safer magnets will promote bone healing faster after the bone is wounded during implant placement. |
Evaluation will be done using Radiovisiography (RVG) at day 15,45,75. |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
16 implants will be used for this
study. Two implants will be placed in each patient in the anterior mandible
corresponding to the B and D regions and the implant on the D region will be
exposed to magnetic field using safer magnet (Neodymium Boron Iron) and the
implant on the B region served as a control. Investigation of Implant Stability
Quotient (ISQ) values for stability will be done using Resonance Frequency Analyzer (RFA)
at Days 0, 30, 60 and 90.
|
|