| CTRI Number |
CTRI/2020/09/027942 [Registered on: 21/09/2020] Trial Registered Prospectively |
| Last Modified On: |
17/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of clinical efficiency of two different functional appliances in treatment of retruded mandible. |
|
Scientific Title of Study
|
Comparative Evaluation of Dentoskeletal parameters using AdvanSync and Herbst Appliance in the treatment of Class II malocclusion - A CBCT Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Keerti Kaushik |
| Designation |
Post Graduate Student |
| Affiliation |
SGT Dental College |
| Address |
Department of Orthodontics,
Faculty of dental sciences,
SGT university.
Chandu Budhera, Gurugram-Badli Road.
Gurgaon
HARYANA
122505
India |
| Phone |
7206667232 |
| Fax |
|
| Email |
drkeertikaushik01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Grover |
| Designation |
Head of the department |
| Affiliation |
SGT Dental College |
| Address |
Department of Orthodontics,
Faculty of dental sciences,
SGT university.
Chandu Budhera, Gurugram-Badli Road.
Gurgaon
HARYANA
122505
India |
| Phone |
9810636828 |
| Fax |
|
| Email |
seemaortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keerti Kaushik |
| Designation |
Post Graduate Student |
| Affiliation |
SGT Dental College |
| Address |
Department of Orthodontics,
Faculty of dental sciences,
SGT university.
Chandu Budhera, Gurugram-Badli Road.
Gurgaon
HARYANA
122505
India |
| Phone |
7206667232 |
| Fax |
|
| Email |
drkeertikaushik01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Orthodontics,SGT Dental College |
|
|
Primary Sponsor
|
| Name |
Dr Keerti Kaushik |
| Address |
Department of Orthodontics,
Faculty of Dental Sciences,
SGT University,
Chandu Budhera, Gurugram- Badli Road.
Gurugram |
| 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 Keerti Kaushik |
SGT Dental College |
Department of Orthodontics,
Faculty Of Dental sciences,
Gurugram-Badli Road, Gurugram
Gurgaon
HARYANA |
7206667232
drkeertikaushik01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Advansync and Herbst appliance is used. |
The efficiency of two Fixed Functional Appliances ( Advansync and Herbst) in correcting the dentoskeletal malocclusion in skeletal Class II patients will be evaluated.
The patients will be called every month for regular treatment and followup till 6 months. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients in CVMI staging 2,3,4
2. Class II Malocclusion (ANB >4o)
3. Horizontal or average growth pattern
4. Minimum crowding in dental arch
5. Positive Visual Treatment Objective (VTO)
|
|
| ExclusionCriteria |
| Details |
1. Patients above CVMI staging 4
2. Class II Malocclusion (ANB <4 degrees)
3. Vertical growth pattern
4. crowding in dental arch
5. Negative Visual Treatment Objective (VTO) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the skeletal and dental changes produced by AdvanSync and Herbst appliance using CBCT. |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
25/09/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is basically designed to evaluate the dental and skeletal changes of AdvanSync appliance using CBCT, To evaluate the dental and skeletal changes of Herbst appliance using CBCT and then to compare the dental & skeletal changes of AdvanSync appliance with those treated with Herbst appliance using CBCT. The results will be evaluated by comparing pre- treatment and post-treatment CBCT within a span of 6 months. |