| CTRI Number |
CTRI/2025/05/087636 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Jaw Joint position changes before and after initial Orthodontic treatment in patients with Class I and Class II malocclusions using 2D and 3D imaging |
|
Scientific Title of Study
|
Comparative evaluation of Condylar position in patients with Class I, Class II Division 1 and Class II Division 2 malocclusion before and after levelling and alignment using Lateral Cephalogram and Cone Beam Computed Tomography An Invivo Clinical 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 |
Dr VEERENDRA KERUDI |
| Designation |
HEAD OF DEPARTMENT, DEPARTMENT OF ORTHODONTICS |
| Affiliation |
ACPM DENTAL COLLEGE DHULE |
| Address |
DEPARTMENT OF ORTHODONTICS ROOM NO 6 JMFs ACPM DENTAL COLLEGE SAKRI ROAD DHULE
Dhule
MAHARASHTRA
424001
India |
| Phone |
7507399666 |
| Fax |
|
| Email |
drveerendrakerudi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SAURAVI NIMBALKAR |
| Designation |
POST-GRADUATE STUDENT |
| Affiliation |
ACPM DENTAL COLLEGE DHULE |
| Address |
DEPARTMENT OF ORTHODONTICS ROOM NO 6 JMFs ACPM DENTAL COLLEGE, SAKRI ROAD, DHULE
Dhule
MAHARASHTRA
424001
India |
| Phone |
7030371737 |
| Fax |
|
| Email |
sauravinimbalkar7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAURAVI NIMBALKAR |
| Designation |
POST-GRADUATE STUDENT |
| Affiliation |
ACPM DENTAL COLLEGE DHULE |
| Address |
DEPARTMENT OF ORTHODONTICS ROOM NO 6 JMFs ACPM DENTAL COLLEGE, SAKRI ROAD, DHULE
MAHARASHTRA
424001
India |
| Phone |
7030371737 |
| Fax |
|
| Email |
sauravinimbalkar7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SAURAVI NIMBALKAR |
| Address |
DEPARTMENT OF ORTHODONTICS ROOM NO 6 JMFs ACPM DENTAL COLLEGE SAKRI ROAD DHULE MAHARASHTRA INDIA 424001 |
| 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 |
| SAURAVI NIMBALKAR |
JMFs ACPM DENTAL COLLEGE DHULE |
DEPARTMENT OF ORTHODONTICS ROOM NO 6 JMFs ACPM DENTAL COLLEGE SAKRI ROAD DHULE MAHARASHTRA INDIA 424001
Dhule
MAHARASHTRA |
7030371737
sauravinimbalkar7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ACPM DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levelling and Alignment of teeth |
The Levelling and Alignment of teeth will be carried out using the round and rectangular Nickel Titanium wires |
| Comparator Agent |
Not applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with Class I molar relation bilaterally, intra-arch malocclusions and Class I skeletal bases
2) Patients with Class II molar relation bilaterally and retrognathic mandible
3) Patients with retroclination of upper incisors and Deep bite
4) Patients with increased Overjet
5) Age group:- 14 years and above
6) Patients with no congenital defects
7) Patients without any history of Orthodontic treatment
8) No signs and symptoms of TMJ disorders
9) Patients with good periodontal status
|
|
| ExclusionCriteria |
| Details |
1) Patients with Class III skeletal bases
2) Patients who have undergone Orthodontic treatment.
3) Patients with facial asymmetry
4) Patients with signs and symptoms of TMJ disorders
5) Patients with craniofacial anomalies
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in condylar position in patients with Class I, Class II Division 1 and Class II Division 2 malocclusions before and after the levelling and alignment phase of Orthodontic treatment. |
At baseline and after levelling and alignment |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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)
|
10/06/2025 |
| 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="6"
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
|
This study aims to evaluate and compare the position of the mandibular condyle in patients with Class I, Class II Division 1 and Class II Division 2 malocclusions before and after the levelling and alignment phase of Orthodontic treatment. Using both Lateral Cephalogram and Cone Beam Computed Tomography, the study investigates whether early Orthodontic intervention affects the condylar position and whether these changes differ across malocclusion types. The findings are intended to enhance understanding of condylar adaptations during Orthodontic treatment. |