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CTRI Number  CTRI/2024/04/066457 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 26/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   3D Printed VS Conventional Occlusal Splint for Patients with Temporomandibular Joint Disorders. 
Scientific Title of Study   Comparison of 3D Printed Occlusal Splint Versus Conventional Occlusal Splint in Treating Temporomandibular Joint Disorder Utilizing Advanced Digital Assessment Techniques - 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  Maaz Maksood Vohra 
Designation  PG student 
Affiliation  Saveetha Dental College 
Address  Department Of Prosthodontics, Saveetha Dental College and Hospitals, 162, Poonamallee High Road, Velappanchavadi, Chennai

Thiruvallur
TAMIL NADU
600077
India 
Phone  08308419570  
Fax    
Email  maazvohra390@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Amrutha Shenoy 
Designation  Senior Lecturer 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department Of Prosthodontics, Saveetha Dental College and Hospitals, 162, Poonamallee High Road, Velappanchavadi, Chennai

Thiruvallur
TAMIL NADU
600077
India 
Phone  8308419570  
Fax    
Email  Amruthashenoyd.sdc@saveetha.com  
 
Details of Contact Person
Public Query
 
Name  Amrutha Shenoy 
Designation  Senior Lecturer 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department Of Prosthodontics, Saveetha Dental College and Hospitals, 162, Poonamallee High Road, Velappanchavadi, Chennai

Thiruvallur
TAMIL NADU
600077
India 
Phone  8308419570  
Fax    
Email  Amruthashenoyd.sdc@saveetha.com  
 
Source of Monetary or Material Support  
Clinic 24, Floor number- 4, Department of Prosthodontics, Saveetha Dental College and Hospital, 162, Poonamalle High Road, Chennai, 600077 
 
Primary Sponsor  
Name  Saveetha Dental College and Hospital 
Address  162, Poonamallee High Road, Velappanchavadi, Chennai- 600077 
Type of Sponsor  Research institution and hospital 
 
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 Maaz Vohra  Saveetha Dental College and Hospital  Clinic 24, Department Of Prosthodontics, 162, Poonamallee High Road, Velappanchavadi, Chennai, 600077
Thiruvallur
TAMIL NADU 
08308419570

maazvohra390@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Dental College - Institutional Human Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  3D Printed Occlusal splint  Occlusal splint fabricated using 3D printing technology using denture base resin used for 3 weeks 
Comparator Agent  Conventional Occlusal Splint  Occlusal splint fabricated using conventional compression Moulding technique using acrylic resin used for 3 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Participants between the ages of 18 and 65 years.
2.Participants with disc displacement.
3.Participants with generalized dental attrition or loss of VDO or sensitivity due to loss of occlusal enamel.
4.Patient with full arch dentition.
5.No active periodontal disease.
6.Participants with good general health.
7.Participants who have given written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1.Participants with a known allergy to Polymethylmethacrylate.
2.Participants with systemic diseases affecting the oral cavity, such as uncontrolled diabetes, autoimmune diseases, or cancer.
3.Patient with impacted, partially erupted third molars.
4.Pregnant or breastfeeding women.
5.Participants with a history of mental illness or cognitive impairment.
6.Participants with history of recent multiple teeth extractions.
7.Participants with a history of severe periodontal disease or tooth mobility.
8.Participants with missing teeth that require immediate restoration.
9.Participants who are unable to comply with the study protocol or attend follow-up visits.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue scale (VAS)  Baseline, 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
T Scan evaluation  Baseline, 3 weeks 
Joint Vibration Analysis (JVA)  Baseline, 3 weeks 
Chair Time   Insertion day 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   11/05/2024 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Temporomandibular Disorders (TMD) affect jaw movement, causing pain and discomfort. Treatment often involves occlusal splints, traditionally made with heat-cured acrylic. Advancements in 3-D printing offer new possibilities, but their effectiveness needs evaluation. Current research relies on subjective measures, lacking objective tools like T-Scan and Joint Vibration Analysis. Comparing conventional techniques with 3-D printed splints could provide insights into treatment success. Thus, a thorough assessment is necessary before transitioning to digital workflows in removable prosthetics. The aim of this study was to compare and evaluate the effectiveness of 3D printed occlusal splints to conventional occlusal splints in treating Temporomandibular Joint Disorder, utilizing advanced digital evaluation tools in a human trial. Specifically, the objectives were to compare the performance of 3D printed occlusal splints with conventional ones using advanced digital tools like JVA and T-scan, assess the efficiency of 3D printed occlusal splints in managing TMJ disorders, and measure TMJ pain levels using the visual analogue scale. The study was designed as a blinded crossover randomized controlled trial in accordance with the CONSORT guidelines. Twenty patients requiring occlusal splint therapy were included in the study based on the selected inclusion and exclusion criteria. Patients were divided into two groups. Each group received stabilization occlusal splint, one fabricated using conventional compression molding technique and the other using 3D printing technique with a 2-week follow-up period. The outcome measures were Pain assessment using VAS, occlusal contacts using T-scan, and TMJ health assessment using JVA. 

 
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