| CTRI Number |
CTRI/2019/07/020050 [Registered on: 05/07/2019] Trial Registered Prospectively |
| Last Modified On: |
20/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of skeletal class II malocclusion using two different fixed functional appliance |
|
Scientific Title of Study
|
Comparative evaluation of clinical efficacy of two class II correctors in treatment of skeletal class II malocclusion. A randomised controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Shiv Shankar Agarwal |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department of Orthodontics & Dentofacial Orthopedics
Armed Forces Medical College, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7086104044 |
| Fax |
|
| Email |
docshivagarwal@rediffmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Shiv Shankar Agarwal |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department of Orthodontics & Dentofacial Orthopedics
Armed Forces Medical College, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7086104044 |
| Fax |
|
| Email |
docshivagarwal@rediffmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Shiv Shankar Agarwal |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department of Orthodontics & Dentofacial Orthopedics
Armed Forces Medical College, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
7086104044 |
| Fax |
|
| Email |
docshivagarwal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical Research Committee, Director General Armed Forces Medical Services, M Block, Ministry of Defence , New Delhi01 |
|
|
Primary Sponsor
|
| Name |
Director General Armed Forces Medical Services |
| Address |
M Block
Integrated HQ, Ministry of Defence
new Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Oo DGDS |
L Block
Integrated HQ, Ministry of Defence
New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Lt Col ShivShankar Agarwal |
Armed Forces Medical College |
First Floor, Div of Orthodontics, Department of Dental Surgery, Armed Forces Medical College
Pune
MAHARASHTRA |
7086104044
docshivagarwal@rediffmail.com |
| Maj RajKumar Maurya |
Army Dental Centre R and R Delhi |
Second floor, Department of Orthodontics, Army Dental Centre R and R Delhi
South
DELHI |
7000139308
bracedbyraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, AFMC Pune |
Approved |
| Institutional Ethical Committee, Army Dental Centre Research and Referral Delhi |
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 |
FORSUS FRD |
Fixed Functional Appliancewill be given after alignment of upper lower arches for six to eight months or till the time correction is achieved |
| Comparator Agent |
POWERSCOPE 2 |
Fixed Functional Appliance for Mandibular Advancement will be given after alignment of upper lower arches for six to eight months or till the time correction is achieved |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases of Class II malocclusion (ANB>4 degrees)
2. Molar relation class II/Half cusp class II
3. Overjet > 4mm
4. Positive Visual Treatment Objective
5. CVMI stage III-V
6. No missing or supernumerary teeth
7. Patients giving written consent to participate in the study
8. No h/o previous orthodontic treatment/trauma to jawbones
|
|
| ExclusionCriteria |
| Details |
1. Negative VTO
2. History of previous orthodontic treatment
3. Systemic diseases affecting bone metabolism
4. Patients with neuromuscular disorders & TMJ problems
5. Insufficient teeth/periodontal status to support the appliance
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correction of Skeletal Class II malocclusion |
after completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To compare treatment duration between the study groups.
b) To compare chairside time taken for appliance insertion and removal between the study groups
c) Patient comfort and operator convenience
d) Frequency of breakage of appliance and bracket debonding
|
After completion of treatment |
|
|
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)
|
15/07/2019 |
| 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="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Various removable and fixed functional appliances are used for correction of skeletal Class II malocclusion with retrognathic mandible in growing patients. In patients who report after the pubertal growth spurt or during the late stages of puberty with minimal growth left, fixed functional appliances are a treatment of choice. They are often called "non-compliant Class II correctors" as they require minimum patient co-operation unlike removable appliances. The Forsus FRD (3M Unitek Corp., Monrovia, Calif) is one of the most commonly used fixed functional appliance for correction of Class II malocclusion. But it is often associated with limitations like frequent breakage of canine brackets and soft tissue lacerations. It is available in various sizes, hence a large inventory must be maintained and chairside time is increased as correct size for individual patient needs to be selected. The PowerScope 2 (American Orthodontics, Sheboygan, Wis) is the latest addition to the orthodontist’s armamentarium. It comprises of several modifications in the original PowerScope to deliver latest, simple and efficient Class II correction. PowerScope 2 features a stronger wire attachment nut and visual activation indicators. It is available as a one-size-fits-all appliance, preassembled with attachment nuts for quick and easy chairside application. It provides a wire-to-wire installation with attachments placed mesial to the first molar in the maxillary arch and distal to the canine in the mandibular arch. Apart from a few case reports and clinical studies, literature evaluating the treatment efficacy of PowerScope and comparing with other fixed functional appliance like Forsus FRD is limited and at present there is no published study on the latest generation PowerScope 2. Thus, the purpose of this study is to evaluate the clinical efficacy of PowerScope 2 appliance in the treatment Skeletal Class II malocclusion and compare with Forsus FRD. The null hypothesis is that there is no significant difference in treatment effects between PowerScope 2 and Forsus. |