| CTRI Number |
CTRI/2021/02/031571 [Registered on: 25/02/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing treatment effects on hyoid bone and cervical posture by two different appliances which bring the lower jaw forward. |
|
Scientific Title of Study
|
Evaluating Treatment Effects Of Herbst And Advansync On Hyoid Bone And Cervical Posture In Skeletal Class II Malocclusion |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ARCHANA JAGLAN |
| Designation |
PG Second Year |
| Affiliation |
Sgt Dental College |
| Address |
Department of orthodontics
Faculty of dental sciences
SGT University
Near Badli Road
Chandu Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
8839858394 |
| Fax |
|
| Email |
archanajaglan506@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Grover |
| Designation |
Professor |
| Affiliation |
Sgt Dental College |
| Address |
Department of orthodontics
Faculty of dental sciences
SGT University
Near Badli Road
Chandu Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
9810636828 |
| Fax |
|
| Email |
seema.grover@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Grover |
| Designation |
Professor |
| Affiliation |
Sgt Dental College |
| Address |
Department of orthodontics
Faculty of dental sciences
SGT University
Near Badli Road
Chandu Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
9810636828 |
| Fax |
|
| Email |
seema.grover@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics,
Faculty of Dental Sciences,
SGT University
Chandu-Budhera,
Gurugram 122505
India |
|
|
Primary Sponsor
|
| Name |
DR ARCHANA JAGLAN |
| Address |
Department of orthodontics
Faculty of dental sciences
SGT University
Near Badli Road
Chandu Budhera
Gurugram 122505 |
| 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 Archana Jaglan |
SGT University |
Department of orthodontics
Faculty of dental sciences
Gurgaon
HARYANA |
8839858394
archanajaglan506@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethical committee,Faculty of dental sciences,SGT University,Gurgaon |
Approved |
| Ethical committee,Faculty of dental sciences,SGT University,Gurgaon |
Approved |
| Ethical committee,Faculty of dental sciences,SGT University,Gurgaon |
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 |
| Comparator Agent |
Advansync Appliance |
Advansync appliance will be given to the patients for a duration of 6 to 8 months for correction of skeletal class II malocclusion. |
| Intervention |
Herbst Appliance |
Herbst appliance will be given to the patients for a duration of 6 to 8 months for correction of skeletal class II malocclusion. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
1) Skeletal Class II malocclusion.
2) Retrognathic mandible.
3) Positive virtual treatment objective (VTO).
4) Minimum crowding in dental arches.
|
|
| ExclusionCriteria |
| Details |
1) Evidence of systemic disease.
2) Poor oral hygiene.
3) Missing first permanent molar.
4) Severe crowding in dental arches.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Upon removal of Herbst and advansync appliance changes in hyoid bone and cervical posture will be evaluated. |
After 7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Upon removal of Herbst and advansync appliance other changes produced will be assessed. |
7 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/03/2021 |
| 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="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary purpose of the protocol is to compare and analyze the positional changes of Hyoid
bone and change in Cervical Posture following fixed functional therapy with
Herbst and Advansync appliance in Skeletal Class II malocclusion. |