Post Graduate Institute of Dental Sciences, Rohtak
Rohtak, Haryana, 124001, India
NCT Number: NCT07760428
Occlusal splint therapy is a well-established conservative approach for the management of temporomandibular disorders (TMDs); however, variability in clinical outcomes suggests that no single splint design is universally optimal. Conventional chairside stabilization splints are widely used and allow immediate intraoral adjustments; however, they are technique-sensitive and may compromise long-term fit and patient comfort. Conversely, 3D-printed occlusal splints provide superior precision, reproducibility, and material stability; however, their uniformly rigid structure may limit initial comfort and patient compliance, particularly in patients with acute pain or muscle tenderness.
To address these limitations, the researchers intend to develop an innovative hybrid occlusal splint i.e. Dual material 3D printed stabilization splint, that integrates both hard and soft components. This design aims to combine the biomechanical stability and occlusal precision characteristic of rigid splints with the cushioning effect and enhanced comfort provided by soft splints. The objective is to improve adaptation, compliance, and the sustained therapeutic efficacy of the splint.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Not applicable
Rohtak, Haryana, 124001, India
Temporomandibular disorders (TMDs) are a diverse group of musculoskeletal and neuromuscular conditions affecting the temporomandibular joint (TMJ), masticatory muscles, and associated structures, leading to pain, functional limitations, and impaired quality of life.5 They encompass more than 30 different conditions that may involve the TMJ, the surrounding masticatory muscles (such as the masseter, temporalis, and pterygoid muscles), or a combination of both.Occlusal splints have long been a cornerstone of TMD management due to their reversibility, simplicity, and efficacy in redistributing occlusal forces, reducing bruxism, and promoting neuromuscular adaptation.16 Understanding their diverse presentation, underlying risk factors, and biopsychosocial context is essential for effective assessment, diagnosis, and management.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional chairside stabilization splints for treatment of temporomandibular joint disorders.
3d printed stabilization splint for treatment of temporomandibular joint disorders.
Other names: 3d printed single material stabilization splint
3d printed hybrid stabilization splint for treatment of temporomandibular joint disorders.
Other names: novel hybrid dual material stabilization splint
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
To evaluate and contrast pain relief by using the Visual Analog Scale (VAS).The scale ranges from 0 to 10 where 0 is the minimum VAS score and 10 is the maximum score. Score of 0 indicates no pain and score of 10 indicates maximum pain intensity.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
To evaluate functional improvement by Measuring the change in Maximum Mouth Opening (MMO) in millimetres from baseline to 1 month.
Time frame: baseline, 1 week, 2 weeks, 4 weeks
To quantify masticatory efficiency by measuring changes in Maximum Bite Force (MBF) using a bite force analyser device.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
To evaluate patient compliance and comfort using Likert Scale. The Likert Scale is a 5-point scale where 1 is the minimum score and 5 is the maximum score. Score 1 indicates very dissatisfied and Score 5 indicates very satisfied.
Contact information is provided by the study sponsor or research team.
Dr. Harneet Singh, MDS
CONTACT
Dr. Subhadeepa Paul
CONTACT
Postgraduate Institute of Dental Sciences Rohtak
Other
Comparative Efficacy of Conventional, 3D-Printed, and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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