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CTRI Number  CTRI/2018/08/015164 [Registered on: 01/08/2018] Trial Registered Prospectively
Last Modified On: 19/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Surgical Approach to Accelerate the Orthodontic tooth movement  
Scientific Title of Study   Effect of micro-osteoperforations on rate of orthodontic tooth movement along with the evaluation of GCF biomarkers and alveolar bone density 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preeti Preeti 
Designation  Junior resident 3 
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  9336594653  
Fax    
Email  drpradeepraghav@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 Preeti (Self) a-30, Patrakarpuram colony, Near Arogya Mandir, Gorakhpur, UP 
 
Primary Sponsor  
Name  Dr Preeti 
Address  Subharti Dental college, SVSU, Meerut 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preeti  Subharti Dental college, SVSU, Meerut, UP  Room No. 7, 2nd floor, Department of orthodontics
Meerut
UTTAR PRADESH 		 9336594653

drpradeepraghav@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects undergoing Orthodontic treatment for esthetic reasons, but all subjects will be healthy as per our inclusion criteria 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lance Pilot Drill for microosteoperforations  Lance Pilot Drill for microosteoperforations 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  17.00 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 bilateral maxillary canine ditalization were included
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   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to observe the rate of orthodontic tooth movement with micro-osteoperforations  Total time period - 4 months
Patient will be recalled at every 7,14, 21, 28 days for first month and thereafter at every 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
To check the level of biomarkers at different time points and to assess the change in bone density level   0, 7,14, 21, 28 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   07/08/2018 
Date of Study Completion (India) 11/03/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="28" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This split-mouth design will compare the rate of orthodontic tooth movement with micro - osteoperforation. The study contains 30 subjects in experimental group . Three micro-osteoperforations will be performed with lance pilot drill, in the extraction site distal to canine just before retraction . The level of alveolar bone density will be measured  at T1 (1 week) and T2 (1 month) time interval . The GCF biomarkers for orthodontic tooth movement will be measured at 0,7,14,21 and 28 days. The treatment duration will be of 4 months / till the completion of canine retraction. 
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