FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/102982 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 04/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Laser Therapy With and Without a New Jaw Joint Locating Device in Skeletal Class II Patients Receiving Functional Orthodontic Treatment 
Scientific Title of Study   Assessing the clinical accuracy of low level Lesar therapy in skeletal calss II patents undergoing myofunctional appliance therapy with-versus without extraoral condyle locating device and further evaluating the comparative clinical efficacy of said two therapy approaches: a randomised controlled trial 
Trial Acronym  nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SHILPA M KENDRE 
Designation  PHD Scholar 
Affiliation  Sharad Pawar Dental College and Hospital Sawangi Wardha 
Address  Dept of Orthodontics Sharad Pawar Dental College and Hospital Sawangi Wardha

Latur
MAHARASHTRA
442001
India 
Phone  09420685304  
Fax    
Email  shilpabikkad80@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pallavi Digavane 
Designation  prof PHD Guide 
Affiliation  Sharad Pawar Dental College and Hospital Sawangi Wardha 
Address  Dept of Orthodontics Sharad Pawar Dental College and Hospital Sawangi Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9923355361  
Fax    
Email  pallavi.ortho@dmiher.edu.in   
 
Details of Contact Person
Public Query  
Name  DR SHILPA M KENDRE 
Designation  PHD Scholar 
Affiliation  Sharad Pawar Dental College and Hospital Sawangi Wardha 
Address  Dept of Orthodontics Sharad Pawar Dental College and Hospital Sawangi Wardha

Latur
MAHARASHTRA
442001
India 
Phone  09420685304  
Fax    
Email  shilpabikkad80@gmail.com  
 
Source of Monetary or Material Support  
not applicable 
 
Primary Sponsor  
Name  DR SHILPA M KENDRE 
Address  Dept of Orthodontics Sharad Pawar Dental College and Hospital 442004 maharashtra India Sawangi Wardha  
Type of Sponsor  Other [self sponcerd] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr shilpa kendre   sharad pawar dental college and hospital wardha  department of orthodontics Sharad Pawar Dental College Datta Meghe Institute of medical science campus sawangi wardha 442004 maharashtra india
Wardha
MAHARASHTRA 		 9420685304

shilpabikkad80@gmail.com 
DR SHILPA KENDRE  sharad pawar dental college wardha  department of orthodontics Sharad Pawar Dental College Datta Meghe Institute of medical science campus sawangi
Wardha
MAHARASHTRA 		 09420685304

shilpabikkad80@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  patents reporting to Orthodontic department  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  non guided LLLT application  LLLT will be applied over the condylar area using conventional anatomical estimation, without EOCLD guidance. The same laser settings and myofunctional appliance protocol will be used. 
Intervention  Phase I EOCLD Validation time required 30 days Phase IIEOCLD Guided LLLT with Myofunctional Appliance time required 8 months   Participants will undergo condylar localization using the newly developed Extraoral Condyle Locating Device (EOCLD). The identified point is marked extraorally and verified radiographically to assess accuracy. Intra and inter operator reliability will be recorded.Low-level laser therapy LLLT will be delivered over the condylar region using EOCLD for precise localization. Laser parameters and frequency follow standard orthodontic photobiomodulation protocols. All subjects will also wear a Twin Block/myofunctional appliance. 
 
Inclusion Criteria  
Age From  13.00 Day(s)
Age To  35.00 Day(s)
Gender  Both 
Details  • Age group: 10–35 years

• No prior orthodontic or orthopedic treatment

• Normal TMJ function and absence of pain or clicking
 
 
ExclusionCriteria 
Details  Exclusion criteria
• Patients with craniofacial syndromes, cleft lip/palate, or any congenital facial deformities.
• History of previous orthodontic or orthopedic treatment.
• Presence of systemic diseases (e.g., growth hormone disorders, juvenile arthritis) affecting growth.
• Temporomandibular joint (TMJ) disorders, pain, or restricted mouth opening at baseline
• Patients with poor oral hygiene, active dental caries, or periodontal disease.
• Uncooperative behaviour or inability to follow study protocols.
• Contraindications to LLLT, such as photosensitivity, epilepsy, or ongoing medication affecting bone metabolism.
• Inability or refusal to undergo CBCT imaging.
• Patients with metal allergies or hypersensitivity to appliance materials 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
phase 1-Accuracy (mm deviation) of EOCLD vs radiographic condyle location
phase 2-Condylar growth changes ( position, dimension) 		 phase 1-Accuracy (mm deviation) of EOCLD vs radiographic condyle location 30 days for pilot study
phase 2-Condylar growth changes ( position, dimension) 8 months after appliance delivary 
 
Secondary Outcome  
Outcome  TimePoints 
Phase 1-ICC intra-/inter-operator reliability, repeatability, time efficiency, operator feedback Phase 2-Skeletal changes (ANB, mandibular length), functional outcomes, soft tissue changes, treatment duration, discomfort, compliance, adverse effects   
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   18/02/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

This two phase study aims to develop validate and clinically evaluate a newly designed Extraoral Condyle Locating Device EOCLD for precise targeting of low level laser therapy LLLT during myofunctional appliance treatment in skeletal Class II patients Phase I involves fabrication of the EOCLD followed by assessment of its clinical accuracy and reliability in localizing the mandibular condyle using radiographic confirmation as the reference standard Phase II is a randomized controlled trial comparing the efficacy of EOCLD guided LLLT versus conventional non guided LLLT when used with myofunctional appliance therapy Primary outcomes include condylar growth and adaptive remodeling assessed through 3D radiographic measurements The study aims to determine whether anatomically guided LLLT improves treatment precision and enhances mandibular growth modifications compared to standard laser application

 
Close