| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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. |