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CTRI Number  CTRI/2021/09/036454 [Registered on: 13/09/2021] Trial Registered Prospectively
Last Modified On: 21/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Effectiveness of a modified intraoral photobiomodulator for increasing the orthodontic tooth movement 
Scientific Title of Study   Effectiveness of a Customized intraoral photo-biomodulator for accelerating orthodontic tooth movement 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manoghna Subramanya H 
Designation  postgraduate student 
Affiliation  faculty of dental sciences, ramaiah university of applied sciences 
Address  Department of orthodontics and dentofacial orthopedics, faculty of dental sciences,ramaiah university of applied sciences,new BEL road, MSR nagar,bangalore

Bangalore
KARNATAKA
560054
India 
Phone  7829333356  
Fax    
Email  manuhs_1995@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashantha GS 
Designation  Professor & HOD 
Affiliation  Faculty of dental sciences, ramaiah university applied sciences 
Address  Department of orthodontics and dentofacial orthopedics, faculty of dental sciences,Ramaiah University of applied sciences,new BEL road,MSR nagar,bangalore

Bangalore
KARNATAKA
560054
India 
Phone  9886242624  
Fax    
Email  pacchi77@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manoghna Subramanya H 
Designation  postgraduate student 
Affiliation  Faculty of dental sciences, ramaiah university applied sciences 
Address  Department of orthodontics and dentofacial orthopedics, faculty of dental sciences,ramaiah university of applied sciences,new BEL road,MSR nagar, bangalore

Bangalore
KARNATAKA
560054
India 
Phone  7829333356  
Fax    
Email  manuhs_1995@yahoo.com  
 
Source of Monetary or Material Support  
Department of orthodontics and dentofacial orthopedics, faculty of dental sciences,ramaiah university of applied sciences, bangalore 
 
Primary Sponsor  
Name  Dr Manoghna Subramanya H 
Address  Department of orthodontics and dentofacial orthopedics,faculty of dental sciences,ramaiah university of applied sciences, bangalore 
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 Manoghna Subramanya H  faculty of dental sciences, ramaiah university of applied sciences  Room number-8,2nd floor,Department of orthodontics and dentofacial orthopedics,faculty of dental sciences, ramaiah university of applied sciences, new BEL road, MSR nagar ,bangalore
Bangalore
KARNATAKA 
7829333356

manuhs_1995@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
university ethics committee for human trials approval, ramaiah university of dental sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  angles class1 malocclusion with bimaxillary protrusion  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A customised intraoral photobiomodulator  this device is made up of acrylic and LED lights which is customised to every patient in order to accelerate the tooth movement by conventional method of retraction using active tie backs 
Comparator Agent  conventional method of retraction   retraction is done by using active tie backs 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Class I Bimaxillary cases needing all 4 extraction
Between age group of 14 to 30years
 
 
ExclusionCriteria 
Details  Patients under any other medication which affects tooth movement
Patients with craniofacial anomalies
Patients with periodontal disease
Patients with any kind of systemic disease that affects tooth movement
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Rate of the tooth movement in photobiomodulator treated patients and non photobiomodulator treated patients will be measured and compared   time frame :4 months
every month the amount of tooth movement will be evaluated by measuring from the distal aspect of canine to mesial aspect of second premolar and compared with control side 
 
Secondary Outcome  
Outcome  TimePoints 
1. Effect of photobiomodulator on root resoption
2. Effect of photobiomodulator on pulp vitality status 
1. 4months
Root lengths from patients will be measured using CBCT at the start of treatment and 4 months after the treatment.
These measurements will be compared with both the groups.
2. 4months
cold test will be done on the respective tooth before the treatment and after the treatment 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   15/09/2021 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

One of the common deterrents to orthodontic treatment is the length of time for active phase. In literature, authors have reported about 20-30 months to complete the orthodontic treatment. Although there are many methods to increase the rate of tooth movement, they are associated with discomfort, pain and invasiveness. Hence, there is a need for a non- invasive, cost effective and user friendly method of reducing the treatment time. Photobiomodulation (PBM), also known as low-level light therapy (LLLT), attempts to use low energy lasers or light-emitting diodes (LED) to modify cellular biology by exposure to light in the red to near-infrared (NIR) range (600–1000 nm). NIR light therapy has been linked to increase mitochondrial metabolism, wound healing and the promotion of angiogenesis in skin, bone, muscle, and nervous tissues. In this study, a customized intraoral photo-biomodulator made of acrylic and near-infrared LED lights incorporated into it will be used. The patients will be subjected to experiment based on randomly assigned split mouth design to prevent individual biologic variation. Pre-adjusted edgewise MBT prescription bracket system will be used with 0.022 slot and anchorage reinforcement by auxiliaries like Transpalatal arch and lingual arch or 2nd molar banding will be decided. After levelling and aligning, during the retraction phase photobiomodulation will be used. Patients are advised to use this photobio-modulator everyday for 3mins in the morning after brushing and before breakfast for an interval of 4 months.

 
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