| CTRI Number |
CTRI/2023/04/051524 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the methods used to faster the orthodontic tooth movement in humans |
|
Scientific Title of Study
|
A comparative assessment of tooth movement through an Invasive and Non-invasive method using Microosteoperforation and Low-Level Laser Therapy: An In-vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soumya Gupta |
| Designation |
PhD Scholar |
| Affiliation |
D. Y. Patil School of Dentistry, Nerul Navi Mumbai |
| Address |
Department of Orthodontics and Dentofacial Orthopedics.
D.Y. Patil School of Dentistry Nerul Navi Mumbai
Mumbai
MAHARASHTRA
400706
India |
| Phone |
09770170432 |
| Fax |
|
| Email |
drsoumyagupta8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya Gupta |
| Designation |
PhD Scholar |
| Affiliation |
D. Y. Patil School of Dentistry, Nerul Navi Mumbai |
| Address |
Department of Orthodontics and Dentofacial Orthopedics
D.Y. Patil School of Dentistry Nerul Navi Mumbai
Mumbai
MAHARASHTRA
400706
India |
| Phone |
09770170432 |
| Fax |
|
| Email |
drsoumyagupta8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Ashok |
| Designation |
Professor |
| Affiliation |
New Horizon Dental College and Research Institue |
| Address |
Department of Orthodontics and Dentofacial Orthopedics.
New Horizon Dental College and Research Institue, Sakri
Bilaspur
CHHATTISGARH
495001
India |
| Phone |
9966985853 |
| Fax |
|
| Email |
akortho1977@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dental College and private clinics |
|
|
Primary Sponsor
|
| Name |
Dr Soumya Gupta |
| Address |
Department of Orthodontics and Dentofacial Orthopedics
D.Y. Patil School of Dentistry Nerul, Navi Mumbai |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr D Ashok |
New Horizon Dental College and Research Institute, Sakri, Bilaspur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soumya Gupta |
Dental college and hospitals and private dental clinic |
New Horizon Dental College and Research Institute
Bilaspur
CHHATTISGARH |
7000630775
drsoumyagupta8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals that require orthodontic treatment. BIMAXILLARY PROTRUSION WITH ANGLES CLASS I MALOCCLUSION |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
The contralateral site in the same patient will be the control group as split mouth study. |
| Intervention |
Invasive method (MOP) |
MOPs will be performed under local anesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis. No flap will be raised. The soft tissue thickness shall be measured using a periodontal probe with a stopper before performing each MOP. Three MOPs shall be performed gingival to the extraction site (either right or left side) distal to the maxillary canines at coronal, middle, and apical regions, using the mini-screw implant. A rubber stopper will be used to standardize the depth of penetration of the mini-screw implant. Each perforation will be 1.5 mm wide and 3-5 mm deep in the bone. MOP procedure will be repeated every 3 weeks for 3 months. |
| Intervention |
Non-Invasive method (LLLT) |
Low-level laser therapy using gallium-aluminum-arsenide (GaAlAs) diode laser that delivers with a power output of 2 W in a continuous noncontact wave mode. The laser device tip will be placed in a non-contact mode in each site, perpendicular to the root (either on the right or left side) for bio-stimulation on both (mesial and distal) surfaces of the maxillary canine. So, there will be a total of 6 application points- 3 mesial surfaces and 3 distal surfaces. The exposure time will be 10 seconds for each application point for 60 seconds. The treatment will be divided into four applications with an appointment interval of 3 weeks for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy periodontal condition.
2. Patients with Angle’s Class I malocclusion with bimaxillary protrusion who require extraction of maxillary first premolars and all first premolars.
3. Average Growth Pattern or Normo-divergent FMA is between 21degree to 29degree
4.No previous history of orthodontic treatment.
5. The full complement of teeth present except 3rd molars.
|
|
| ExclusionCriteria |
| Details |
1. Long-term use of analgesics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.
2. Extreme skeletal malocclusions indicate orthognathic surgery.
3. Any systemic disease.
4. Patient with the habit of gutka chewing, pan chewing, and smoking.
5. Patient with poor oral hygiene and periodontally compromised teeth.
6. Potential participants who did not consent to the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Orthodontic Tooth Movement by Micro-osetoperforation and photobiostimulation by low-level laser therapy on the rate of canine retraction.
|
Each patient will be observed for 3 months for the study purpose. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a. To determine the amount and rate of canine retraction by surgical (MOP) method. |
3 months |
b. To determine the amount and rate of canine retraction by non-surgical (low-level laser therapy) methods |
3 months |
c. To evaluate the pain perception of patients during canine retraction in all the study groups.
|
1 months |
d. To compare the rate of maxillary canine retraction between all 4 Groups and, anchorage loss in all the study groups.
|
1 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/05/2023 |
| 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="3"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Gupta, S., and Soni, V. P. (2022). Effect of various biological ways on the orthodontic tooth
movement: A review. International Journal of Health Sciences, 6(S2), 13002–13011.
https://doi.org/10.53730/ijhs.v6nS2.8422
International Journal of Health Sciences ISSN 2550-6978 E-ISSN 2550-696X © 2022.
Manuscript submitted: 09 March 2022, Manuscript revised: 18 April 2022, Accepted for publication: 27 May 2022
13002 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double-blinded, before and after study, a prospective study, an experimental comparative, and a control, split-mouth clinical study. The study is to evaluate the rate of canine retraction using accelerated orthodontics methods MOPs and LLLT in orthodontic cases. The Primary Outcome will measure the rate of retraction with the accelerated orthodontics method over a 3-month time period. The secondary outcome will assess the pain using the VAS scale and anchor loss in the molar during the course of treatment. |