| CTRI Number |
CTRI/2024/04/065925 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the skeletal and dental effects of backward movement of lower teeth with bone screws using different orthodontic mechanics |
|
Scientific Title of Study
|
Comparative evaluation of skeletal and dental changes following mandibular en masse distalization with buccal shelf screws - A randomised controlled trial between two orthodontic mechanics |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisshitha Rao Setvaji |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha Institute of Medical and Technical Scienes, Department of Orthodontics, 162, Poonamallee High Rd, Velappanchavadi
Chennai
TAMIL NADU
600116
India |
| Phone |
9884500115 |
| Fax |
|
| Email |
nisshitha.rao97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shantha Sundari |
| Designation |
Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha Institute of Medical and Technical Scienes, Department of Orthodontics, 162, Poonamallee High Rd, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
shanthasundari@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Nisshitha Rao Setvaji |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha Institute of Medical and Technical Scienes, Department of Orthodontics, 162, Poonamallee High Rd, Velappanchavadi
Chennai
TAMIL NADU
600116
India |
| Phone |
9884500115 |
| Fax |
|
| Email |
nisshitha.rao97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Institute of Medical and Technical Sciences |
|
|
Primary Sponsor
|
| Name |
Nisshitha Rao Setvaji |
| Address |
Clinic 27, Department of Orthodontics, Saveetha Dental College and
Hospital, Saveetha Institute of Medical and Technical Sciences, Poonamalle High Road |
| 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 Nisshitha Rao Setvaji |
Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences |
Clinic 27, Department
of Orthodontics and
Dentofacial
Orthopaedics,
Saveetha Dental
College and Hospital, Saveetha Institute of Medical and Technical Sciences, 162
Poonamalle High Road
Chennai
TAMIL NADU |
9884500115
nisshitha.rao97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College & Hospital Institutional Ethics Committee SDC IHEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Class lll patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.017 x 0.025 inch stainless steel archwires for lower arch distalization |
Subjects requiring en masse mandibular arch distalization using buccal shelf screws for a period of 5 months |
| Comparator Agent |
0.019 x 0.025 inch stainless steel archwires for lower arch distalization |
Subjects requiring en masse mandibular arch distalization using buccal shelf screws for a period of 5 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Class lll skeletal and dental relationships of all growth patterns
Extracted lower third molars
No other missing or extracted teeth |
|
| ExclusionCriteria |
| Details |
Subjects with Class l and ll skeletal and dental relationships were excluded. Subjects with facial asymmetry or asymmetrical arches were excluded. Subjects with missing teeth or functional deviations on occlusion were excluded. Subjects with craniofacial syndromes or physically or mentally handicapped were excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Linear (mm) and angular (degrees) skeletal and dental changes |
Baseline, 5 months and 10 months (end of distalization). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of mandibular arch distalization, anterior & posterior anatomical limits, soft tissue changes, tongue position, hyoid position & airway volume changes |
Baseline, 5 months & 10 months (end of distalization) |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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
Response - Analytic Code
- 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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nisshitha.rao97@gmail.com].
- For how long will this data be available start date provided 16-01-2025 and end date provided 16-01-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A comparative evaluation of skeletal and dental changes following mandibular en masse distalization with buccal shelf screws - A randomised controlled trial between two orthodontic mechanics
Aim: To compare and evaluate the skeletal and dental changes following lower en masse distalization with buccal shelf screws between two orthodontic mechanics
Sample size: 18 patients
Randomised controlled clinical trial
Group 1: Distalization with a statically determinate system Group 2: Distalization with a statically indeterminate system
Methodology: Linear and angular skeletal and dental changes calculated between the pre distalization and post distalization CBCT values.
The rate of lower molar distlization to be calculated by dividing the amount of distalization by the time taken to achieve Angle’s Class l molar relationship.
Primary and secondary parameters to be measured from the pre and post distalization CBCTs and the difference between the two orthodontic biomechanics to be calculated. |