| CTRI Number |
CTRI/2025/03/082929 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing the Effects of Advansync2 and Twin Block on Jaw and Teeth Growth in Class II Patients – A 3D X-ray Study |
|
Scientific Title of Study
|
To Evaluate And Compare The Skeletal, Dentoalveolar And Soft Tissue Changes Occurring In Skeletal Class II Patients Using Advansync2 And Twin Block – A CBCT 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 RUSHIKESH SHANKARRAO KADAMAM |
| Designation |
MDS post graduate student |
| Affiliation |
school of dental sciences Krishna Vishwa Vidyapeeth Karad |
| Address |
room no. 41, department of orthodontics school of dental sciences Krishna Vishwa Vidyapeeth Karad
Satara
MAHARASHTRA
415539
India |
| Phone |
9146436473 |
| Fax |
|
| Email |
kadamrushikesh540@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR YUSUF AHAMMED AR |
| Designation |
Associate professor |
| Affiliation |
school of dental sciences Krishna Vishwa Vidyapeeth Karad |
| Address |
room no. 41, department of orthodontics school of dental sciences Krishna Vishwa Vidyapeeth Karad,415539
Satara
MAHARASHTRA
415539
India |
| Phone |
7709367197 |
| Fax |
|
| Email |
dryusufar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR YUSUF AHAMMED AR |
| Designation |
Associate professor |
| Affiliation |
school of dental sciences Krishna Vishwa Vidyapeeth Karad |
| Address |
room no. 41, department of orthodontics school of dental sciences Krishna Vishwa Vidyapeeth Karad,415539
Satara
MAHARASHTRA
415539
India |
| Phone |
7709367197 |
| Fax |
|
| Email |
dryusufar14@gmail.com |
|
|
Source of Monetary or Material Support
|
| room no. 41, department of orthodontics school of dental sciences Krishna Vishwa Vidyapeeth India, maharashtra, Karad,415539 |
|
|
Primary Sponsor
|
| Name |
school of dental sciences Krishna Vishwa Vidyapeeth Karad |
| Address |
room no. 41, department of orthodontics school of dental sciences Krishna Vishwa Vidyapeeth India, maharashtra, Karad,415539 |
| Type of Sponsor |
Other [dental college ] |
|
|
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 rushikesh shankarrao kadam |
school of dental sciences Krishna Vishwa Vidyapeeth Karad |
room no. 41, department of orthodontics school of dental sciences Krishna Vishwa Vidyapeeth India, maharashtra, Karad,415539
Satara
MAHARASHTRA |
09146436473
kadamrushikesh540@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutionalethicscommitteekrishnavishwavidyapeeth(deemedtobeuniversity)karad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
normal healthy person |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
advansync2 and twin block appliance |
advansync2 is the fixed functional appliance used to correct the jaw discrepancy
twin block appliance is the myofunctional appliance used to correct the jaw discrepancy |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Patients having permanent or mixed dentition
Patients with Class 2 div 1 malocclusion
|
|
| ExclusionCriteria |
| Details |
Cleft lip and Palate
Mentally challenged patients
Adult patient age more than 17 yrs
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SNA angle
SNB angle
ANB angle
Co-pt A
Co-Gn
Co-Go
WITS
FMA
UI – pt A (angle)
UI-pt A (linear)
LI-pt B (angular)
LI-pt B (linear)
upper lip – E-plane
lower lip – E-plane
H-line angle
|
10 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
UI – pt A (angle)
UI-pt A (linear)
LI-pt B (angular)
LI-pt B (linear)
upper lip – E-plane
lower lip – E-plane
|
3 months, 6 months, 10 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
05/04/2025 |
| 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
|
·
Very few investigators have studied the effect
of advansync2 in skeletal class II malocclusion. Previous literatures report comparative cephalometric
study of advansync2 and twin block, where they studied skeletal, dentoalveolar, and soft tissue changes in
sagittal and vertical direction. The purpose of the present
study is to evaluate the skeletal, dentoalveolar, and soft tissue changes
in sagittal, transverse and vertical direction using CBCT.
|