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CTRI Number  CTRI/2022/12/048181 [Registered on: 16/12/2022] Trial Registered Prospectively
Last Modified On: 15/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Method to test rate of tooth movement by perforating bone using mini-implants 
Scientific Title of Study   EFFECT OF MINI IMPLANT ASSISTED MICRO-OSTEOPERFORATION ON ORTHODONTIC TOOTH MOVEMENT A RANDOMIZED CLINICAL TRIAL  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shresthaa Singh  
Designation  Post Graduate Student  
Affiliation  Hazaribag College of Dental Sciences and Hospital. 
Address  Room no -6, Department of Orthodontics and Dentofacial Orthopedics, Hazaribag College of Dental Sciences and Hospital

Hazaribag
JHARKHAND
825301
India 
Phone  8436962922  
Fax    
Email  shresth1947@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Abhay Kumar Jain 
Designation  Professor and Guide 
Affiliation  Hazaribag College of Dental Sciences and Hospital  
Address  Room no 6, Department of Orthodontics and Dentofacial Orthopedics. Hazaribag College of Dental Sciences and Hospital

Hazaribag
JHARKHAND
825301
India 
Phone  9897063692  
Fax    
Email  docabhayjain@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Abhay Kumar Jain 
Designation  Professor and Guide 
Affiliation  Hazaribag College of Dental Sciences and Hospital  
Address  Room no 6, Department of Orthodontics and Dentofacial Orthopedics. Hazaribag College of Dental Sciences and Hospital

Dhanbad
JHARKHAND
825301
India 
Phone  9897063692  
Fax    
Email  docabhayjain@gmail.com  
 
Source of Monetary or Material Support  
Hazaribag College of Dental Sciences and Hospital 
 
Primary Sponsor  
Name  Dr Shresthaa Singh  
Address  Hazaribag College of Dental Sciences and Hospital, Demotand, Hazaribagh, Jharkhand -825301 
Type of Sponsor  Other [SELF] 
 
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 Shresthaa Singh  Hazaribag College of Dental Sciences and Hospital  Department of Orthodontics and Dentofacial Orthopedics, Room no -6. Hazaribag College of Dental Sciences and Hospital. Demotand, Hazaribag, Jharkhand - 825301
Hazaribag
JHARKHAND 		 8436962922

shresth1947@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hazaribag College of Dental Sciences and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K006||Disturbances in tooth eruption,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  micro-osteoperforation using mini implants on one side  micro-osteoperforation is done once just before canine retraction and the rate of tooth movement is observed at 28th and 56th day of the study after micro osteoperforation 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Patients with Angle’s Class I Bimaxillary protrusion (indicated all first premolar extraction)

2. Class II Div1 malocclusion (indicated for bilateral maxillary first premolar extraction)

3. All subjects undergoing treatment with Pre-adjusted Edgewise Mechanotherapy

4. Subjects who have completed the leveling and alignment (1st Phase).

5. No systemic disease.

6. No radiographic evidence of bone loss.

7. No history of periodontal disease.

8. No current active periodontal disease.

9. No smoking.

10. No gingivitis or untreated caries.
 
 
ExclusionCriteria 
Details  1. Previous history of orthodontic treatment.

2. Presence of craniofacial anomalies.

3. Presence of any signs and symptoms of gingival and periodontal diseases.

4. Long-term use of phenytoin sodium, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.

5. Poor oral hygiene for more than 2 visits.

6. Severe skeletal Class II malocclusion, overjet more than 10 mm.

7. Systemic diseases.

8. Evidence of bone loss.

9. Past periodontal disease.

10. Smoking.

11. Gingivitis and caries
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
the rate of orthodontic tooth movement of canine in extraction space after micro-osteoperforation  56 days 
 
Secondary Outcome  
Outcome  TimePoints 
to access pain and discomfort level of the patient in the experimental and control side  1 hour, 24 hour, 72 hour, 7th day, 28th day. 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   17/12/2022 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shresth1947@gmail.com].

  6. For how long will this data be available start date provided 01-07-2022 and end date provided 26-08-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The study is randomized clinical trial being done to evaluate the effect of modified micro-osteoperforation (MOP)  on the rate of orthodontic tooth movement over a period of two months. In addition we will be accessing the impact of the number of perforations on the rate of orthodontic tooth movement. The level of pain and discomfort if any will also be accessed among the patients. Patients who visit the Department of Orthodontics and Dentofacial Orthopedics will be taken for the trial after written consent has been taken from them. Two groups will be taken and marked as MOP-1 and MOP-2. MOP-1 group having 3 MOP on one side and MOP-2 having 6 MOP on one side. In each patient other side of the mouth is taken as control side which recieves no MOP. Alginate impressions will be taken and casts poured immediately in the start of the procedure and after 28 and again after 56 days. The rate of retraction of teeth will be measured via these casts using vernier callipers and results will be taken accordingly.

 
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