| CTRI Number |
CTRI/2019/03/018140 [Registered on: 18/03/2019] Trial Registered Prospectively |
| Last Modified On: |
24/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of surgically assisted accelerated tooth movement on En-masse retraction |
|
Scientific Title of Study
|
To assess the rate of orthodontic tooth movement through micro-osteoperforation assisted maxillary anterior en-masse retraction |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranav Bhasin |
| Designation |
Junior resident 2 |
| Affiliation |
Subharti Dental college |
| Address |
Room no. 7, 3rd floor, Dept. of Orthodontics, Subharti Dental College, SVSU, Meerut, Uttar Pradesh
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9910935365 |
| Fax |
|
| Email |
pranav.bhasin10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Raghav |
| Designation |
HOD, Dept. of Orthodontics |
| Affiliation |
Subharti Dental college |
| Address |
Room no. 7, 3rd floor, Dept. of Orthodontics, Subharti Dental College, SVSU, Meerut, Uttar Pradesh
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09837175914 |
| Fax |
|
| Email |
drpradeepraghav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep Raghav |
| Designation |
HOD, Dept. of Orthodontics |
| Affiliation |
Subharti Dental college |
| Address |
Room no. 7, 3rd floor, Dept. of Orthodontics, Subharti Dental College, SVSU, Meerut, Uttar Pradesh
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09837175914 |
| Fax |
|
| Email |
drpradeepraghav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Pranav Bhasin (self) House Number- 47, ground floor, Navjeevan Vihar, Delhi- 110017 |
|
|
Primary Sponsor
|
| Name |
Dr Pranav Bhasin |
| Address |
Subharti Dental College, SVSU, Meerut |
| Type of Sponsor |
Other [self funded] |
|
|
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 Pranav Bhasin |
Subharti Dental college, SVSU, Meerut, UP |
Room no. 7, 2nd floor, Dept. of Orthodontics, Subharti Dental College, SVSU, Meerut, Uttar Pradesh
Meerut
UTTAR PRADESH |
09837175914
pranav.bhasin10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical committee, Subharti Dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subjects undergoing routine orthodontic treatment for esthetic reasons, hence requiring extraction of first premolar and en-masse retraction of maxillary anterior. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lance Pilot Drill for microosteoperforations |
Lance Pilot Drill is used for microosteoperforations, drilling 5mm into the buccal cortical bone in 3 seconds.
microosteoperforation is performed before the start of retraction, 2 mesial and 3 distal to the canine. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with Angle’s Class I malocclusion, Angle’s Class I bimaxillary malocclusion and Class II bimaxillary and Angle’s class II div I malocclusion requiring 1st premolar extraction and anterior en-masse retraction
2. Only those patients were included in which atraumatic 1st premolar extraction was done.
3. The performance of MOPs and canine retraction was done at least 4 months after the extraction procedure to remove the bias due to the RAP induced due to extraction.
4. Canine roots to be in cancellous bone.
5. No radiographic evidence of bone loss.
6. Patient with good oral hygiene.
|
|
| ExclusionCriteria |
| Details |
1. Patients on long term use of antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs were discarded
2. Patients on systemic corticosteroids and calcium channel blockers were not included in the study.
3. Patients with history of periodontal therapy 4. Patients with untreated caries, gingivitis and h/o smoking were not included in the study. |
|
|
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 |
| To observe the rate of orthodontic tooth movement with micro-osteoperforation |
total time period - 7 months
patient is recalled every 28 days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the overall treatment time for en-masse retraction |
total time period - 7 months or till the completion of retraction |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
18/03/2019 |
| Date of Study Completion (India) |
30/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a radomized clinical trial, to compare the duration of en-masse retraction with micro-osteoperforation. The study consist of 60 subjects. which will be randomly divided into experimental and control group, with 30 subjects in each group. Ten micro-osteoperforations will be performed with the help of lane pilot drill, three distal to canine and 2 mesial to canine, bilaterally, just before retraction. The rate of tooth movement is observed every month and treatment duration will be 7 months/ till the completion of canine retraction. |