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CTRI Number  CTRI/2025/10/096228 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 16/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Mouth splints for jaw muscle pain: testing traditional versus 3D-printed designs to ease pain and improve opening and side movements 
Scientific Title of Study   Comparative Evaluation Of The Effectiveness Of Conventionally Fabricated Occlusal Splints With Computer-Aided Design And Computer-Aided Manufacturing (Cad/Cam) 3d-Printed Occlusal Splints In Reducing Pain, Improving Mouth Opening And Lateral Jaw Movements In Patients With Temporomandibular Disorders: A Randomized Controlled Trial. 
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 Mohit Mulchandani 
Designation  Post Graduate Student 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India

Nagpur
MAHARASHTRA
441110
India 
Phone  8983346837  
Fax    
Email  drmohit1912@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Girish Kubasad 
Designation  Professor and PG Guide 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India

Nagpur
MAHARASHTRA
441110
India 
Phone  7259405630  
Fax    
Email  dr.girishkubasad@sdk-dentalcollege.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Girish Kubasad 
Designation  Professor and PG Guide 
Affiliation  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. 
Address  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India

Nagpur
MAHARASHTRA
441110
India 
Phone  7259405630  
Fax    
Email  dr.girishkubasad@sdk-dentalcollege.edu.in  
 
Source of Monetary or Material Support  
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India 
 
Primary Sponsor  
Name  Dr Mohit Mulchandani 
Address  Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India 
Type of Sponsor  Other [Self Sponsor] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohit Mulchandani  Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital , Hingna, Nagpur.  104, First Floor, Department of Prosthodontics, Crown And Bridge, Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. Maharashtra, India Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA 		 8983346837

drmohit1912@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 
Patients  (1) ICD-10 Condition: M266||Temporomandibular joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  • Patients irrespective of gender will be selected.
• Patients aged between 18-55 years will be selected.
• Patients with temporomandibular disorder pain.
• Patients with myofascial or temporomandibular joint pain.
• Patients with symptoms indicated for treatment with occlusal splints.
• Volunteer patients who agree to give informed consent will be considered as individuals for the research.
 
 
ExclusionCriteria 
Details  1)Patient with recent facial and temporomandibular joint trauma.
2)Patients with autoimmune diseases involving
temporomandibular joint.
3)Patients with systemic conditions (e.g., diabetes, arthritis).
4)Patient using medication affecting central nervous system.
5)Patients wearing orthodontic appliance.
 
 
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 
Reduction in jaw pain measured on the Visual Analogue Scale (VAS), comparing baseline to follow-up after splint therapy in adults with myogenic temporomandibular disorders. This captures the core therapeutic target of symptom relief for muscle-related TMD pain  3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   22/12/2025 
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="6"
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 randomized controlled trial compares traditional occlusal splints with CAD CAM 3D printed splints in patients with myogenous temporomandibular disorders to assess pain reduction mouth opening and lateral jaw movements. TMD commonly causes jaw pain limited movement and reduced quality of life and stabilization splints are a standard conservative treatment. Conventional PMMA splints are labor intensive and can have defects while digital workflows using intraoral scanning and CAD CAM aim to improve fit comfort and efficiency. The study aims to determine whether CAD CAM splints provide equal or superior clinical outcomes versus conventional splints. 
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