| CTRI Number |
CTRI/2018/03/012423 [Registered on: 08/03/2018] Trial Registered Prospectively |
| Last Modified On: |
11/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
fixed functional appliance in growing versus non growing age |
|
Scientific Title of Study
|
To compare the therapeutic effect of molar to molar fixed functional appliance in class II malocclusion at different stage of skeletal maturity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivani Mathur |
| Designation |
2nd year postgraduate student |
| Affiliation |
Subharti Dental College, Swami Vivekanand Subharti University |
| Address |
Department of Orthodontics
Subharti Dental College,
Swami Vivekanand Subharti University
Meerut, UP, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9868127340 |
| Fax |
|
| Email |
shivanimathur18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Raghav |
| Designation |
HOD, Department of Orthodontics |
| Affiliation |
Subharti Dental College, Swami Vivekanand Subharti University |
| Address |
Department of Orthodontics
Subharti Dental College
Swami Vivekanand Subharti University
Meerut, UP, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09837175914 |
| Fax |
|
| Email |
drpradeepraghav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Raghav |
| Designation |
HOD, Department of Orthodontics |
| Affiliation |
Subharti Dental College, Swami Vivekanand Subharti University |
| Address |
Department of Orthodontics
Subharti Dental College
Swami Vivekanand Subharti University
Meerut, UP, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09837175914 |
| Fax |
|
| Email |
drpradeepraghav@gmail.com |
|
|
Source of Monetary or Material Support
|
| self
173 AGCR Enclave
Delhi-110092 |
|
|
Primary Sponsor
|
| Name |
Dr Shivani Mathur |
| Address |
Department of Orthodontics
Subharti Dental College,
Swami Vivekanand Subharti University
Meerut, UP, India
|
| Type of Sponsor |
Other [Self-funded] |
|
|
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 Shivani Mathur |
Subharti Dental College, Swami Vivekanand Subharti University, Meerut, UP |
Department of orthodontics and Dentofacial Orthopaedics, Room No. 7, 2nd floor
Meerut
UTTAR PRADESH |
09868127340
shivanimathur18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committee, Subharti Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals with class II skeletal and dental malocclusion with retrognathic mandible, requiring functional therapy to enhance the growth of mandible. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Molar to Molar fixed functional appliance
|
Molar to Molar fixed functional appliance
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria-
1.Skeletal and dental class II malocclusion due to retrognathic mandible
2.Normal- horizontal growth pattern
3.Age criteria 12-20 years and CVMI stage 2-6
4.Absence of any developmental anomaly
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1.Extracted or Missing teeth
2.Presence of gingival disease
3.Mentally challenged patient’
4.Patient with any know systemic disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skeletal and Dental changes |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the result of fixed functional in late CVMI stage |
8 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2018 |
| Date of Study Completion (India) |
04/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study was performed to compare the effect of molar to molar AdvanSync2 fixed functional appliance in Class II malocclusion subjects at different stages of skeletal maturation. The appliance was given to subjects with Class II skeletal pattern due to retrognathic mandible for a period of 6-9 months. Study participants were categorised according to their skeletal maturation stages into 2 groups – Circumpubertal ( CVMI 2 and 3) and Post pubertal ( CVMI 4, 5 and 6).The skeletal and dental effect of fixed functional appliance in both the groups were compared using cephalometric findings at pre and 9 months post placement of the appliance. The study determined the effectiveness of the appliance and correlated it with the stage of skeletal maturity.
|