| CTRI Number |
CTRI/2018/05/013953 [Registered on: 17/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of small holes in gums in speeding up the tooth alignment |
|
Scientific Title of Study
|
Effect of two time micro-osteperforations on rate of orthodontic tooth movement– 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 |
Jaiswal Abhijeet Ashokrao |
| Designation |
Junior Resident |
| Affiliation |
Centre for Dental Education and Research |
| Address |
4th floor,
department of orthodontics,
Centre for Dental
education and research, AIIMS,New Delhi-29
centre for dental education and research (4th floor)
all india institute of medical sciences
New Delhi
DELHI
110029
India |
| Phone |
9096960990 |
| Fax |
|
| Email |
abjaiswal1612@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ritu Duggal |
| Designation |
Professor |
| Affiliation |
Centre for Dental Education and Research |
| Address |
4th floor,
department of orthodontics,
Centre for Dental
education and research, AIIMS,New Delhi-29
centre for dental education and research (4th floor)
all india institute of medical sciences
New Delhi
DELHI
110029
India |
| Phone |
783839003 |
| Fax |
|
| Email |
rituduggal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfRItu Duggal |
| Designation |
Professor |
| Affiliation |
Centre for Dental Education and Research |
| Address |
4th floor, department of orthodontics,centre for dental education and research,AIIMS,New Delhi
centre for dental education and research (4th floor)
all india institute of medical sciences
New Delhi
DELHI
110029
India |
| Phone |
7838390003 |
| Fax |
|
| Email |
rituduggal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| centre for dental education and research, AIIMS |
|
|
Primary Sponsor
|
| Name |
Centre For Dental Education and Research |
| Address |
Centre for Dental Education and Research,AIIMS |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jaiswal Abhijeet Ashokrao |
Centre for Dental Education and Research |
4th floor,
department of orthodontics,
Centre for Dental
education and research, AIIMS,New Delhi-29
New Delhi
DELHI |
9096960990
abjaiswal1612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitee for Post graduate Research All India Institute of Medical Sciences,Ansari nagar, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
severely proclined upper and lower teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
one time micro osteo perforation in other side of upper arch |
micro osteoperforation will be done using the specially designed appliance |
| Intervention |
Two time MIcroosteoperforation in one side of in upper arch |
Micro-osteoperforations will be performed with disposable appliance designed for this purpose by Propel Orthodontics (Ossining,NY) under Local Anaesthesia ( lignocaine 2% with 1:100000 epinephrine) |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases of Class II div1 or Bimaxillary Protrusion requiring bilateral maxillary first premolar extraction.
2.Age 15 to 25years irrespective of gender.
3.Erupted permanent canines, premolars and first molars.
4.Healthy periodontal conditions with good level of oral hygiene.
5.No significant medical history or medication that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement.
• Positive inform consent |
|
| ExclusionCriteria |
| Details |
1.Non-compliant patient with inability to maintain proper oral hygiene.
2. H/o anydrug intake/systemic illness affecting bone metabolism.
3.Previous orthodontic treatment.
4..Not willing for informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| faster tooth movement |
0,15,30,45,60,75,90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| type of tooth movement |
0,30,90 days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet known |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Microosteoperforation will be done in healthy individuals with proclined upper and lower teeth and its effect will be studied |