| CTRI Number |
CTRI/2018/03/012331 [Registered on: 05/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing tooth movement rate efficiency,and pain perception between two braces system and a new minimally invasive technique |
|
Scientific Title of Study
|
Comparison of rate of tooth movement, alignment efficiency, irregularity index and pain perception during accelerated tooth movement associated with conventional and passive self ligation appliance assisted with micro-osteoperforation (Alveocentesis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonal attri |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Orthodontics and Dentofacial Orthopedics |
| Address |
Department of Orthodontics, Institute of dental studies and technologies kadrabad, Modinagar, Uttar Pradesh 201201
Institute of dental studies and technologies kadrabad, Modinagar, Uttar Pradesh 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
7351417066 |
| Fax |
01232-224958 |
| Email |
drsonal1203@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Batra |
| Designation |
Head of Department |
| Affiliation |
Department of Orthodontics and Dentofacial Orthopedics, Institute of dental studies and technologies |
| Address |
Department of Orthodontics, Institute of dental studies and technologies kadrabad, Modinagar, Uttar Pradesh 201201
Institute of dental studies and technologies kadrabad, Modinagar, Uttar Pradesh 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9810335961 |
| Fax |
01232-224958 |
| Email |
drpuneetbatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal attri |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Orthodontics and Dentofacial Orthopedics |
| Address |
Department of Orthodontics, Institute of dental studies and technologies kadrabad, Modinagar, Uttar Pradesh 201201
Institute of dental studies and technologies kadrabad, Modinagar, Uttar Pradesh 201201
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
7351417066 |
| Fax |
01232-224958 |
| Email |
drsonal1203@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sonal Attri-
C-17 Moti Prayag near Anand hospital Meerut
Institute of dental studies and technologies kadrabad, Modinagar, Uttar Pradesh 201201
Ghaziabad
UTTAR PRADESH
250002
India |
|
|
Primary Sponsor
|
| Name |
Dr Sonal Attri |
| Address |
C-17 Moti Prayag near Anand hospital Meerut, Uttar Pradesh |
| Type of Sponsor |
Other [Self-funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rashmi Mittal |
Institute of dental studies and technologies kadrabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonal Attri |
Institute of Dental Studies and Technologies, Modinagar |
Department Of Orthodontics and Dentofacial Orthopedics, Institute of Dental Studies and Technologies, Kadrabad, Modinagar, Uttar Pradesh, India
Ghaziabad
UTTAR PRADESH |
917351417066
drsonal1203@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of dental studies and technologies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Class I malocclusion with incisor irregularity of 5-12 mm requiring 1st premolar therapeutic extraction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional brackets using propel device |
Comparison of rate of tooth movement,alignment efficiency,irregularity index movement associated with conventional and passive self-ligation appliance assisted with micro-osteoperforations |
| Intervention |
self-ligating brackets with propel |
Comparison of rate of tooth movement,alignment efficiency,irregularity index movement associated with conventional and passive self-ligation appliance assisted with micro-osteoperforations |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Irregularity index 5-12 mm
Extraction of maxillary and mandibular first premolar extraction
Periodontally sound dentition
Not having analgesics during study period |
|
| ExclusionCriteria |
| Details |
Cases requiring orthognathic surgery
History of medical and system illness
Congenital orofacial deformities
Previous history of orthodontic treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare rate of tooth movement using Propel device |
1 month upto space closure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare alignment efficiency,irregularity index and pain perception |
every 3 weeks of active treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2015 |
| Date of Study Completion (India) |
28/08/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study was done to evaluate and compare the rate of tooth
movement (space closure) followed by micro-osteoperforations (using PROPEL
device), the time required to complete the alignment of crowded anterior
teeth (canine to canine) and pain perception with conventional preadjusted
brackets and self-ligating brackets during the use of PROPEL and during
levelling and aligning. The study
concluded that the rate of tooth movement with respect to space closure was
faster when using PROPEL for micro-osteoperforation in self-ligating group (Damon and Smart clip) as
compared to conventional group with or without the use of PROPEL.The alignment efficiency and irregularity index change
was not statistically significant between different groups.The pain
perception was more in smart clip group (self-ligating group) because of bracket design and door locking mechanism as compared to conventional groups
in initial leveling and aligning phase whereas pain perception using PROPEL
device was found to be
statistically non significant among groups. Thus,
micro-osteoperforation using PROPEL can be used to accelerate tooth movement
with minimal discomfort to the patient especially in self-ligation cases |