| CTRI Number |
CTRI/2019/08/020942 [Registered on: 28/08/2019] Trial Registered Prospectively |
| Last Modified On: |
27/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
treatment outcome of forsus in developing skeletal class III malocclusion |
|
Scientific Title of Study
|
Evaluation of treatmetn outcome of Forsus in developing skeletal Class III malocclusion - a pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjeev Datana |
| Designation |
Assoc Prof |
| Affiliation |
Armed Forces Medical College Pune |
| Address |
Dept OF Dental Surgery and Oral Health Sciences
Armed Forces Medical College
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
|
| Fax |
|
| Email |
drdatana@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeev Datana |
| Designation |
Assoc Prof |
| Affiliation |
Armed Forces Medical College Pune |
| Address |
Dept OF Dental Surgery and Oral Health Sciences
Armed Forces Medical College
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
|
| Fax |
|
| Email |
drdatana@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjeev Datana |
| Designation |
Assoc Prof |
| Affiliation |
Armed Forces Medical College Pune |
| Address |
Dept OF Dental Surgery and Oral Health Sciences
Armed Forces Medical College
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
|
| Fax |
|
| Email |
drdatana@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| O/O DGAFMS
M Block Integrated HQ
Ministry of Defence
New Delhi |
|
|
Primary Sponsor
|
| Name |
Oo DGAFMS |
| Address |
M Block Integrated HQ
Ministry of Defence
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Sanjeev Datana |
AFMC PUNE |
Dept of Dental Surgery and Oral HEalth Sciences
Armed Forces Medical College Pune
Pune
MAHARASHTRA |
9868423593
drdatana@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Armed Forces Mediacl College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental malocclusion |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
i) Developing skeletal class III malocclusion (ANB 0â° to -4â°)
ii) Maxillary deficiency with SNA <78â° (with or without mandibular prognathism)
iii) Angle Class III molar/ super Class I relation with or without anterior crossbite
iv) Minimal or no crowding in maxillary mandibular anterior
v) Permanent dentition with no missing teeth (except 3rd molars)
vi) Patients with CVMI stage 3 and above
vii) No history of previous orthodontic treatment
|
|
| ExclusionCriteria |
| Details |
i) Systemic condition affecting growth and development of jaws
ii) Previous history of orthodontic treatment
iii) Syndromic cases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correction of skeletal class III malocclusion |
after 6 months of appliance placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| skeletal, dental soft tissue changes |
after 6 months of appliance plaement |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
02/09/2019 |
| 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="3"
Months="0"
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)?
|
|
Brief Summary
|
Subjects found suitable in the above inclusion criteria for the study shall be explained the scope of the study and a written consent shall be obtained. Pre treatment records (T1) in the form of Photographs (extraoral& intraoral), Radiographs i.e OPG, Lateral Cephalogram, and Dental Models for maxillary and mandibular arch shall be recorded. Fixed orthodontic appliance will be placed on both maxillary and mandibular arch. After ascertaining the full slot engagement with SS wire, Forsus appliance will be placed in inverted position (reverse to conventional position used for Class II correction). On achieving satisfactory profile improvement / correction in overjet, post functional treatment records (T2) in the form of Photographs (extraoral&intraoral), Radiographs i.e OPG, Lateral Cephalogram, Dental Models for maxillary and mandibular arch shall be obtained. Pre treatmentand post functional treatment lateral Cephalogramshall be analyzedusing various cephalometric values to ascertain the corrections achieved. Corrections achieved will be quantified and will be grouped as Skeletal, Dental & Soft Tissue changes. Any change in the upper air way will also be ascertain using acoustic pharyngometry. In order to reduce the Dental effects of Forsus appliance and to achieve more skeletal results, indirect anchorage will be obtained using TADs (temporary anchorage devices). |