| CTRI Number |
CTRI/2021/12/038869 [Registered on: 23/12/2021] Trial Registered Prospectively |
| Last Modified On: |
21/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
CLINICAL TRIAL TO COMPARE AND EVALUATE THE EFFECTIVENESS OF LOW INTENSITY PULSED ULTRASOUND (LIPUS) AND LOW-LEVEL LASER THERAPY (LLLT) IN TREATING SKELETAL CLASS II CASES WITH FUNCTIONAL APPLIANCES. |
|
Scientific Title of Study
|
A PROSPECTIVE RANDOMISED CLINICAL TRIAL TO COMPARE AND EVALUATE THE EFFECTIVENESS OF LOW INTENSITY PULSED ULTRASOUND (LIPUS) AND LOW-LEVEL LASER THERAPY (LLLT) IN TREATING SKELETAL CLASS II CASES WITH FUNCTIONAL APPLIANCES. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harish B |
| Designation |
Post Graduate student Department of Orthodontics |
| Affiliation |
Sri Hasanamba Dental College and Hospital |
| Address |
Sri Hasanamba Dental College and Hospital
Vidyanagar
Hassan
Hassan
KARNATAKA
573202
India |
| Phone |
9008638863 |
| Fax |
|
| Email |
harishbasavaraj22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reji Abraham |
| Designation |
Head and professor Department of Orthodontics |
| Affiliation |
Sri Hasanamba Dental College and Hospital |
| Address |
Department no. 7
Sri Hasanamba Dental College and Hospital
Vidyanagar
Hassan
Hassan
KARNATAKA
573202
India |
| Phone |
9947181545 |
| Fax |
|
| Email |
rejiabm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harish B |
| Designation |
Post Graduate student Department of Orthodontics |
| Affiliation |
Sri Hasanamba Dental College and Hospital |
| Address |
Sri Hasanamba Dental College and Hospital
Vidyanagar
Hassan
Hassan
KARNATAKA
573202
India |
| Phone |
9008638863 |
| Fax |
|
| Email |
harishbasavaraj22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Hasanamba dental College and Hospital, Vidyanagar, Hassan |
|
|
Primary Sponsor
|
| Name |
Sri Hasanamba dental College and Hospital |
| Address |
Vidyanagr Hassan Karnataka 573202 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Harish B |
Sri Hasanamba dental College and Hospital |
Room no 7, Department of Orthodontics and dentofacial Orthopaedics
Hassan
KARNATAKA |
900868863
harishbasavaraj22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Functional Appliance therapy |
Patients treated with only functional appliance i.e, twin block |
| Intervention |
LOW INTENSITY PULSED ULTRASOUND (LIPUS) |
Low Intensity Pulsed Ultra Sound (LIPUS):
Group I will be receiving ultrasound therapy with functional appliance. The LIPUS therapy will be performed using Elecrtoson 709 ultrasound machine. The sonication is done extra orally on the TMJ region bilaterally daily for first 10 days after placement of functional appliance, followed by 3 times a week for total of 5 weeks. Sonification will be achieved by gently massaging the TMJ area with 1.5MHz frequency pulses with pulse width of 200 microseconds and intensity of 30mW for 20 minutes/side per appointment.
|
| Intervention |
Low Level Laser Therapy (LLLT) |
Low Level Laser Therapy (LLLT):
Group II will be receiving Low Level Laser Therapy (LLLT) with functional appliance. The LLLT will be performed by using Zolar photon diode laser machine. Laser irradiation will be started on the 3rd week after placement of functional appliance. The laser will be applied extra orally on the TMJ region (non-contact mode: 15mm distance from skin) bilaterally 9 min/side for 3 times a week for 5 weeks. The laser exposure will be done at 3 points around TMJ through skin for 9 min (3+3+3) at 3 points in each side per day using 810 nm diode laser with output of 300 mW and energy of 180J with energy density of 5 J/cm2. |
|
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Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient age group between 9-15
2. Skeletal Class II malocclusion with ANB ≥ 4
3. Pre-pubertal patients with CVMI stage below 4
4. Positive VTO
5. Orthognathic maxilla with retrognathic mandible
6. Overjet greater than 5mm
7. Average to horizontal growth pattern
8. Patients who are indicated for mandibular advancement using twin block functional appliance |
|
| ExclusionCriteria |
| Details |
1. Prognathic maxilla with orthognathic mandible
2. Condylar hyperplasia, cleft lip/palate or craniofacial deformities
3. CVMI stage greater than 5
4. Temporomandibular disorders (TMD)
5. History of trauma to the dentofacial region
6. Systemic diseases
7. Patients on long term medications
8. Previous history of orthodontic treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the change in mandibular morphology in skeletal Class II cases treated with functional appliances in conjugation with LIPUS.
2. To evaluate the change in mandibular morphology in skeletal Class II cases treated with functional appliances in conjugation with LLLT.
3. To compare and evaluate the change in mandibular morphology in skeletal Class II cases treated with functional appliances and in conjugation with LIPUS and LLLT.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3. To compare and evaluate the change in mandibular morphology in skeletal Class II cases treated with functional appliances and in conjugation with LIPUS and LLLT. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
31/12/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Class II malocclusions are frequently encountered in orthodontic practices globally and in India. Class II molar relationships occur in a variety of skeletal and dental configurations. The most consistent diagnostic finding in Class II malocclusion is mandibular skeletal retrusion. For many adults with Class II malocclusion with mandibular deficiency, optimal overall results are best obtained with surgical orthodontic approach. However, treating skeletal Class II malocclusions in growing patients by using mandibular propulsive functional appliances, believed to produce satisfactory improvement in facial aesthetics and minimize the need for surgical intervention later. The effects of functional appliances on the remodeling of condyle-glenoid fossa complex have been widely documented in literature. Considering the positive effects of LIPUS and LLLT on condylar regeneration, these methods are used to shorten treatment period for skeletal Class II malocclusion. At present no studies are reported in the literature which compares the effects of LIPUS and LLLT in accelerating condylar regeneration, hence this proposed study will be taken up to compare and evaluate the effectiveness of Low Intensity Pulsed Ultrasound (LIPUS) and Low-Level Laser Therapy (LLLT) in treating skeletal Class II cases with functional appliances. |