| CTRI Number |
CTRI/2024/10/075567 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to assess the rate of tooth movement for patients undergoing orthodontic treatment to correct bimaxillary protrusion by extraction of all first premolars followed by retraction of anterior teeth with and without using Low-Intensity Pulsed Ultrasound therapy |
|
Scientific Title of Study
|
Evaluation and comparison of the rate of orthodontic tooth movement in patients undergoing en-masse retraction with and without Low-Intensity Pulsed Ultrasound (LIPUS) Application: A prospective clinical study |
| Trial Acronym |
LIPUS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Oshin Sharma |
| Designation |
Post-graduate Student |
| Affiliation |
GOVERNMENT COLLEGE OF DENTISTRY, INDORE |
| Address |
Room No. 11, Department of Orthodontics and Dentofacial Orthopedics, 1, Sardar Patel Marg, Opp. M.Y. Hospital, Indore (M.P.)
Indore
MADHYA PRADESH
452001
India |
| Phone |
8319874480 |
| Fax |
|
| Email |
sharmaoshin4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Kishore Ratre |
| Designation |
Professor |
| Affiliation |
GOVERNMENT COLLEGE OF DENTISTRY, INDORE |
| Address |
Room No. 11, Department of Orthodontics and Dentofacial Orthopedics, 1, Sardar Patel Marg, Opp. M.Y. Hospital, Indore (M.P.)
Indore
MADHYA PRADESH
452001
India |
| Phone |
9425070696 |
| Fax |
|
| Email |
rkratre@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Oshin Sharma |
| Designation |
Post-graduate Student |
| Affiliation |
GOVERNMENT COLLEGE OF DENTISTRY, INDORE |
| Address |
Room No. 11, Department of Orthodontics and Dentofacial Orthopedics, 1, Sardar Patel Marg, Opp. M.Y. Hospital, Indore (M.P.)
Indore
MADHYA PRADESH
452001
India |
| Phone |
8319874480 |
| Fax |
|
| Email |
sharmaoshin4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government College of Dentistry, 1, Sardar Patel Marg, Opp. M.Y. Hospital,
Indore (M.P.), India, Pincode - 452001 |
|
|
Primary Sponsor
|
| Name |
Government College of Dentistry Indore |
| Address |
1, Sardar Patel Marg, Opp. M.Y. Hospital, Indore (M.P.), India, Pincode - 452001 |
| Type of Sponsor |
Other [Government Dental College] |
|
|
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 Oshin Sharma |
Government College of Dentistry, Indore |
Room no. 11, Department of Orthodontics and Dentofacial Orthopedics, 1, Sardar Patel Marg, Opp. M.Y. Hospital, Indore
Indore
MADHYA PRADESH |
8319874480
sharmaoshin4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government College of Dentistry Indore Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low-Intensity Pulsed Ultrasound |
Alignment and leveling of all teeth will be completed till 0.019" x 0.025" SS archwire. All first bicuspids will be extracted. Two weeks following extraction, closed coil spring will be attached from hook between the lateral incisor and canine to the hook on molar in each quadrant. LIPUS will be delivered immediately after activation of closed coil springs for en-masse retraction following the regimen on 0,3,5,7,14th day in the first month, and thereafter 15th day of every month till space closure (approximately 9 months) for 20 minutes per jaw. The device to be used for the current study, Boneheal 1000 (Technomed Electronics, Chennai), is customized with the US FDA-approved parameters for LIPUS. LIPUS signal consisting of 1.5 MHz frequency, 1 KHz repetition rate, Output intensity 30 mW/cm2, and 200 µs signal burst width with a probe diameter of 25 mm2 will be used. LIPUS application will be performed on was the soft tissue covering of the face over the gingiva and alveolar mucosa in relation to the buccal aspect of teeth (canine to canine) for both jaws (The target site will be the bone surrounding the anterior teeth). |
| Comparator Agent |
Non-LIPUS |
Alignment and leveling of all teeth will be completed till 0.019" x 0.025" SS archwire. All first bicuspids will be extracted. Two weeks following extraction, closed coil spring will be attached from hook between the lateral incisor and canine to the hook on molar in each quadrant. The retraction will then begin without LIPUS application and coil springs will be reactivated every month and space closure will be assessed. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Class I malocclusion with bimaxillary protrusion.
Average growth pattern of the jaws.
Patients within the age range of 16-25 years.
Patients with rationally advised extraction of first premolars for orthodontic treatment.
Patients with fully erupted permanent dentition.
Patients with good oral and general health.
|
|
| ExclusionCriteria |
| Details |
Patients with pregnancy, systemic disease, or syndromes.
Medication interfering with tooth movement.
Skeletal discrepancy in any of the three planes.
Extracted, missing, or badly decayed permanent teeth (not including 3rd molars).
History of orthodontic treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The rate of orthodontic tooth movement in en-masse anterior teeth retraction with and without LIPUS application in both maxillary and mandibular arches. |
T0 - Beginning of retraction
T1 - 3 months after beginning of retraction
T2 - Completion of retraction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study is a clinical trial to evaluate and compare the rate of orthodontic tooth movement in patients undergoing en-masse retraction with and without Low-Intensity Pulsed Ultrasound (LIPUS) application. The patients requiring all first bicuspid extraction are to be included. Retraction is to be performed using NiTi closed coil springs attached from hooks between canine and lateral incisors to hooks on molars. The amount of space closure is to be recorded every month by measuring the space remaining between canine and second bicuspid in all four quadrants. |