| 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
|
|
|
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
|
|
|
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. |