| CTRI Number |
CTRI/2024/05/066932 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
"Effect of Laser Therapy on Tooth Movement: Does it Speed Up Tooth Movement?" |
|
Scientific Title of Study
|
"A Comparative Analysis of Laser Photobiomodulation Effect on Canine Retraction: A Split Mouth Study" |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pentela Yaswanth Amarnath |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Block 3, Room 6, Department of orthodontics and Dentofacial Orthopaedics,Vishnu Dental College,Vishnupur,Bhimavaram,West Godavari District,Andhra Pradesh
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9100235130 |
| Fax |
|
| Email |
yaswanth.p@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Kumar Varma |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Block 3,Room 6,Department of Orthodontics and Dentofacial Orthopaedics,Vishnu Dental College,Vishnupur,Bhimavaram,West Godavari District,Andhra Pradesh
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8555052429 |
| Fax |
|
| Email |
dpkvarma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Kumar Varma |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Block 3,Room 6,Department of Orthodontics and Dentofacial Orthopaedics,Vishnu Dental College,Vishnupur,Bhimavaram,West Godavari District,Andhra Pradesh
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8555052429 |
| Fax |
|
| Email |
dpkvarma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental college ,Vishnupur,Bhimavaram,Pin code:534202,West Godavari District,Andhra Pradesh,India |
|
|
Primary Sponsor
|
| Name |
Dr Pentela Yaswanth Amarnath |
| Address |
Block 3,Room 6,Department of Orthodontics and Dentofacial Orthopaedics,Vishnu Dental College,Vishnupur,Bhimavaram, Pin code:534202,West Godavari District,Andhra Pradesh |
| 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 Yaswanth Amarnath |
Vishnu Dental College |
Block 3,room 6,Department of orthodontics and Dentofacial orthopaedics,Vishnu Dental college,Bhimavaram
West Godavari
ANDHRA PRADESH |
9100235130
yaswanth.p@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe, Vishnu Dental College,Bhimavaram, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K006||Disturbances in tooth eruption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
laser photobiomodulation |
laser -Diode laser
wavelength- 810 nm
mode - continuous wave,contact mode
site- single large area on buccal and palatal surface of canine
exposure time of 40 sec on each surfaces energy- 8 J/session
Time intervals - after 4 weeks,after 8 weeks,after 12 weeks |
| Comparator Agent |
Tooth movement with friction mechanics alone |
canine retraction will be brought through use of closed NiTi coil springs alone which are attached between canine and first molar.
Measured at time intervals-after 4 weeks,after 8 weeks,after 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Maxillary/mandibular first premolar extraction cases for orthodontic treatment.
2. Age group of 12 – 25 yrs both males and females
|
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled systemic diseases
2. Patients on long-term medication.
3. TMJ disorders
4. Multiple missing teeth
5. Impacted teeth except third molar
6. Periodontally compromised teeth
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tooth movement for individual canine retraction with niti closed coil spring and laser therapy |
Tooth movement for individual canine retraction at 4 weeks, 8 weeks ,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| individual canine retraction with closed niti coil spring alone |
individual canine retraction at 4 weeks, 8 weeks ,12 weeks |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
20/05/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients recommended with first premolar extractions in either jaw for orthodontic treatment will be enrolled in a split-mouth study. Twelve patients meeting the inclusion criteria will participate with their consent. The patients’ jaw quadrants will be divided into test and control groups. In the control group, canine retraction will be performed using only friction mechanics. However, in the test group, laser therapy will be administered in addition to friction mechanics. Laser therapy will be provided every four weeks for a three-month period. The study will last three months for each patient to compare the rate of tooth movement between the control and test sides. To measure the rate of canine retraction, intraoral records will be taken with an intraoral scanner. |