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CTRI Number  CTRI/2021/12/038837 [Registered on: 22/12/2021] Trial Registered Prospectively
Last Modified On: 21/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMAPRISION OF ACCELERATED ALIGNMENT OF CROWDED MANDIBULAR DENTITION WITH LOW LEVEL LASER THERAPY- A RANDOMISED CONTROLLED TRAIL 
Scientific Title of Study   A COMPARATIVE EVALUATION OF EFFICACY OF LOW LEVEL LASER THERAPY IN ACCELERATION OF ALIGNMENT OF CROWDED MANDIBULAR ANTERIORS – A RANDOMISED CONTROLLED 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  Mirali Mashru 
Designation  Postgraduate student 
Affiliation  Pacific dental college and hospital 
Address  Department of orthodontics and Dentofacial Orthopaedics, Room nuber- 6, Pacific dental college and hospital, debari, udaipur, rajasthan
Department of orthodontics and Dentofacial Orthopaedics, Room nuber- 6, Pacific dental college and hospital, debari, udaipur, rajasthan
Udaipur
RAJASTHAN
313024
India 
Phone  7073752755  
Fax    
Email  mashrumirali@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR BHAVESH KOTHARI 
Designation  PROFESSOR 
Affiliation  Pacific dental college and hospital 
Address  Department of orthodontics and Dentofacial Orthopaedics, Room number-6, Pacific dental college and hospital, debari, udaipur, rajasthan
Department of orthodontics and Dentofacial Orthopaedics, Room number- 6, Pacific dental college and hospital, debari, udaipur, rajasthan
Udaipur
RAJASTHAN
313024
India 
Phone  8107868862  
Fax    
Email  drbhaveshkothari@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mirali Mashru 
Designation  Postgraduate student 
Affiliation  Pacific dental college and hospital 
Address  Department of orthodontics and Dentofacial Orthopaedics, Room number- 6, Pacific dental college and hospital, debari, udaipur, rajasthan
Department of orthodontics and Dentofacial Orthopaedics, Room number- 6, Pacific dental college and hospital, debari, udaipur, rajasthan
Udaipur
RAJASTHAN
313024
India 
Phone  7073752755  
Fax    
Email  mashrumirali@gmail.com  
 
Source of Monetary or Material Support  
PACIFIC DENTAL COLLEGE AND HOSPITAL , DEBARI , UAIPUR - 313024 , RAJASTHAN  
 
Primary Sponsor  
Name  Mirali Mashru 
Address  Pacific dental college and hospital , debari , udaipur, rajasthan 
Type of Sponsor  Other [SELF SPONSORED] 
 
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 Mirali Mashru  Pacific dental college and hospital  Department of orthodontics and orthopedics, Room no.6, Pacific dental college and hospital, Debari, Udaipur, Rajasthan
Udaipur
RAJASTHAN 		 7073752755

mashrumirali@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee Research Board (ECRS), Pacific Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K004||Disturbances in tooth formation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LOW LEVEL LASER THERAPY TO STUDY THE ACCELERATION OF ORTHODONTIC TOOTH MOVEMENT  810nm, Soft tissue diode laser applied on mandibular lower anteriors for 4 months to study the acceleration in alignment of crowded mandibular anteriors ( total number of visits- 4) 
Comparator Agent  No soft tissue diode laser is applied in mandibular anteriors  Placebo group received conventional orthodontic treatment for 4 months to relieve crowding with no active lasers (Total number of visits-4) 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Systemically healthy patients in the age range of 16-25 years.
2. Moderate Crowding according to Little’s irregularity index (>5-9mm).
3. Therapeutic extraction cases of Lower first premolars.
4. Completely Erupted Permanent Mandibular teeth
5. Angle’s Class I & Class II malocclusion.
 
 
ExclusionCriteria 
Details  1. Severely displaced teeth
2. Patients on medication such as NSIADS and Hormone supplements.
3. Spacing
4. Periodontally compromised patients
5. Systemic Diseases
6. Patient requiring extraction of lower incisor for crowding correction
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Increase in rate of orthodontic tooth movement and accelerated alignment of crowded mandibular anteriors  0,4,8,12,16 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of pain during alignment  Every 4 weeks pain assessment will be done  
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   31/12/2021 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 22-07-2022 and end date provided 22-07-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
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•      Low Level Laser Therapy have photobiomodulation effect on bone as it activates cytochrome-c oxidase and increases mitochondrial ATP and RANKL which accelerates cellular turnover (i.e. osteoblast, osteoclast, fibroblast). Hence bone remodeling occur.

•      Previous studies evaluated the acceleration rate of orthodontic tooth movement in crowded maxillary incisors, in space closure & pain reduction. None of the study was conducted on alignment of crowded mandibular anteriors.

The present clinical study aims to access acceleration of orthodontic tooth movement using Low Energy Laser Therapy during leveling and alignment phase in crowded mandibular anteriors. 
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