| CTRI Number |
CTRI/2025/03/082191 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
09/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on how teeth alignment changes after braces in people with a specific type of bite issue, using a digital tool to measure the changes. |
|
Scientific Title of Study
|
Digital analysis of changes in occlusal parameters post orthodontic space closure in Angles class II division 1 malocclusion using T scan A prospective 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 |
GSK Jahnavi |
| Designation |
Post Graduate |
| Affiliation |
KAHERS KLE Institute of Dental Sciences Belagavi |
| Address |
Room No-08 Department of Orthodontics and Dentofacial Orthopedics KAHER KLE Institute of Dental Sciences Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9440043525 |
| Fax |
|
| Email |
jahnavigsk1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GSK Jahnavi |
| Designation |
Post Graduate |
| Affiliation |
KAHERS KLE Institute of Dental Sciences Belagavi |
| Address |
Room No-08 Department of Orthodontics and Dentofacial Orthopedics KAHER KLE Institute of Dental Sciences Belagavi
KARNATAKA
590010
India |
| Phone |
9440043525 |
| Fax |
|
| Email |
jahnavigsk1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejashri Pradhan |
| Designation |
Proffesor |
| Affiliation |
KAHER KLE Institute of Dental Sciences Belagavi |
| Address |
Room No-08 Department of Orthodontics and Dentofacial Orthopedics KAHER KLE Institute of Dental Sciences Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7795238850 |
| Fax |
|
| Email |
drtejashri73@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER KLE Institute of Dental Sciences JNMC Campus Nehru nagar Belagavi Karnataka India 590010 |
|
|
Primary Sponsor
|
| Name |
GSK Jahnavi |
| Address |
Room no 8 Department of Orthodontics and Dentofacial Orthopedics KAHER KLE Institute of Dental Sciences Belagavi Karnataka India
590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 GSK Jahnavi |
KAHER KLE Institute of Dental Sciences Belagavi |
Room no 8 Department of Orthodontics and Dentofacial Orthopedics KAHER KLE Institute of Dental Sciences Belagavi
Belgaum
KARNATAKA |
9440043525
jahnavigsk1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Class 2 division 1 malocclusion individuals requiring orthodontic treatment |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Occlusal forces |
Changes in Pre treatment and Post Treatment occlusal force distributions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Angles Class II division 1 malocclusion
Patients who require extractions (all 4s, upper 4s & lower 5s, only upper 4s).
|
|
| ExclusionCriteria |
| Details |
Patients who have undergone Orthodontic/Surgical treatment.
Patients with Angle’s Class I, Class II division 2, Class II subdivision and Class III malocclusion.
Patients with missing teeth, dental implant, fixed prosthesis.
Patients with congenital syndromes, Cleft lip, and palate.
Patients with systemic diseases.
Patients with compromised periodontia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the changes in occlusal force distributions in individuals with Angle’s Class II division 1 malocclusion pre-treatment and post space closure. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determining the effectiveness & impact of extraction on occlusal balance & in achieving improved occlusal function |
1 year |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This prospective study aims to digitally analyze changes in occlusal parameters following orthodontic space closure in individuals with Angle’s Class II division 1 malocclusion, using T-Scan technology. The research focuses on evaluating and comparing occlusal force distributions before treatment, post-space closure, and their impact on occlusal balance and function. By assessing these parameters, the study seeks to determine the effectiveness of orthodontic interventions, including extractions, in achieving improved occlusal harmony and functionality. T-Scan provides a precise, non-invasive method to quantify occlusal force changes, offering valuable insights into the biomechanical outcomes of orthodontic treatment. |