| CTRI Number |
CTRI/2022/09/045772 [Registered on: 22/09/2022] Trial Registered Prospectively |
| Last Modified On: |
01/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Skeletal and dentalveolar changes in individuals treated with Advansync 2 |
|
Scientific Title of Study
|
Comparison of skeletal and dentoalveolar changes in skeletal class II correction with Advansync 2 between two different bracket prescriptions- A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preethi Rajamanickam |
| Designation |
PG |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
No.169, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9003228400 |
| Fax |
|
| Email |
preethirajamanickams@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shantha Sundari |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
No.169, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9444443640 |
| Fax |
|
| Email |
shanthakkss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preethi Rajamanickam |
| Designation |
PG |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
No.169, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9003228400 |
| Fax |
|
| Email |
preethirajamanickams@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dental Matrix,
Authorised distributor of Ormco,
No.601, HMT Layout, RT Nagar, Bengaluru 560032 |
|
|
Primary Sponsor
|
| Name |
K Rajamanickam |
| Address |
4/399, Balaji Nagar II street
Santhosapuram
Chennai 600 073 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Saveetha dental College and Hospital |
No 162, Poonamallee High Road
Velappanchavadi
Chennai 600077 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Preethi Rajamanickam |
Saveetha Dental College and Hospitals, Department of Orthodontics Clinic 27, |
Building No 162, Poonamallee High Road, Velappanchavadi
Chennai 600077
Thiruvallur
TAMIL NADU |
9003228400
preethirajamanickams@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Damon braces with Advansync 2 appliance |
Patients with skeletal class II malocclusion to be treated with Damon braces and Advansync 2 device. The same appliance is activated every 45 days until achievement of class II correction.
Dose, frequency not applicable |
| Comparator Agent |
MBT braces with Advansync 2 device |
Patients with skeletal class II malocclusion to be treated with MBT 0.022X0.028 prescription and Advansync 2 device
The same appliance is activated every 45 days until achievement of class II correction.
Dose, frequency not applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Skeletal class II due to retrognathic mandible
ANB>4 degrees
Growing children
|
|
| ExclusionCriteria |
| Details |
Growing children with Skeletal class II due to prognathic maxillary
Adults with class II malocclusion
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
lower incisor proclamation
mandibular length
SNB
ANB
|
initial, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Soft tissue changes |
initial, 6 months |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/11/2022 |
| 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="1"
Months="6"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [preethirajamanickams@gmail.com].
- For how long will this data be available start date provided 01-03-2023 and end date provided 31-12-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - no
|
|
Brief Summary
|
Comparison of skeletal and dentoalveolar changes in skeletal class II correction with Advansync 2 between two different bracket prescriptions- A randomized controlled trial.
Aim: To compare the skeletal and dentoalveolar changes in skeletal class II correction achieved with Advansync 2 between two different bracket prescriptions.
Objective and rationale To evaluate whether lower incisor proclination can be controlled when Advansync is used in conjunction with Damon. True and adequate mandibular advancement is achieved by maintaining average lower incisor inclination in the mandibular basal bone. Self ligating bracket system mainly achieves tooth alignment and relieves crowding by arch expansion. Arch expansion in Damon self ligating system is greater than that achieved in conventional pre-adjusted edgewise appliance. Excessive proclination of the lower incisors restrict forward rotation of the mandible and also hinders mandibular advancement. Thus this study was undertaken to evaluate the amount of mandibular advancement and other associated skeletal, dentoalveolar and soft tissue changes achieved by both the systems when used in conjunction with Advansync 2 appliance.
Sample size: 22 patients Group 1: 11(Damon with Advansync) Group 2: 11 (MBT with Advansync)
Methodology: 22 growing subjects with Skeletal class II malocclusion selected based on their CVMI staging. Group A (11 subjects) to be treated with MBT with Advansync 2, and Group B (11 subjects) to be treated with Damon Q with Advansync 2. Sample size was determined using G power version 3.0.1 with power of 0.8. Simple random sampling to be done. Case records to be taken for each patient at pre- AdvanSync2 (T1) and post-AdvanSync2 (T2), which includes cephalometric radiographs, extraoral, and intraoral photographs. Informed consent to be obtained from each participant for the use of their case records for scientific research and publication
|