Detailed Description:
Background and Rationale:
Bruxism and temporomandibular joint (TMJ) disorders are common conditions that can lead to jaw pain, headaches, tooth wear, and impaired quality of life. Occlusal splints are commonly prescribed to manage these conditions by stabilizing the jaw and distributing occlusal forces. Standard splints, however, are typically fabricated using uniform designs that do not account for the individual jaw movement patterns of each patient. Recent advances in digital dentistry, including the use of jaw-tracking devices such as MODJAW, allow clinicians to capture three-dimensional mandibular kinematics in real time. By using this information, occlusal splints can be designed to match the specific movement patterns of each patient, potentially improving comfort, jaw function, and clinical outcomes.
This study aims to evaluate whether patient-specific occlusal splints designed using MODJAW kinematic data provide superior clinical outcomes compared to standard occlusal splints.
Study Objectives:
To compare mandibular movement patterns between MODJAW-based patient-specific splints and standard occlusal splints.
To evaluate the effect of MODJAW-based splints on bruxism frequency and intensity.
To assess TMJ pain reduction in participants using MODJAW-based splints versus standard splints.
To determine patient satisfaction and comfort with patient-specific versus standard splints.
Study Design:
This is a prospective, randomized, controlled interventional study. Forty participants with mild-to-moderate bruxism or TMJ dysfunction will be randomly assigned to one of two groups:
MODJAW group (n=20): Participants will receive a patient-specific occlusal splint designed based on 3D mandibular kinematic data collected with MODJAW.
Standard splint group (n=20): Participants will receive a conventional occlusal splint fabricated using standard methods.
The study duration for each participant is 8 weeks, during which participants will wear their assigned splints according to instructions and attend follow-up assessments.
Inclusion Criteria:
Age 18-50 years
Diagnosed with mild-to-moderate bruxism or TMJ dysfunction
Willingness and ability to comply with splint use and study visits
Signed informed consent
Exclusion Criteria:
Severe dental loss or existing prosthetic devices interfering with splint placement
Systemic medical conditions affecting jaw function
History of TMJ trauma or surgery
Pregnancy or breastfeeding
Allergy to splint materials
Study Procedures:
Screening and Baseline Assessment:
Clinical examination of dentition and TMJ
Recording baseline jaw movements using MODJAW (for both groups)
Baseline assessment of bruxism frequency, TMJ pain (VAS score), and patient-reported comfort
Splint Fabrication:
MODJAW group: CAD/CAM splints designed using mandibular movement data captured by MODJAW
Standard group: Conventional splints fabricated according to standard occlusal design
Splint Use:
Participants instructed to wear splints nightly (or as directed) for 8 weeks
Weekly check-ins to monitor compliance and comfort
Follow-Up Assessments (Week 4 and Week 8):
Repeat MODJAW recordings to evaluate changes in mandibular movement
Assess TMJ pain, bruxism frequency and intensity
Collect patient satisfaction and comfort scores via 5-point Likert scale
Record any adverse events
Outcome Measures:
Primary Outcome: Changes in mandibular movement patterns as measured by MODJAW
Secondary Outcomes:
Reduction in TMJ pain (VAS score)
Patient-reported satisfaction and comfort
Data Analysis:
Within-group comparisons: Paired t-tests or Wilcoxon signed-rank tests
Between-group comparisons: Mann-Whitney U test
Categorical outcomes: Chi-square or Fisher's exact test
Statistical significance set at p \< 0.05
Safety Considerations:
Participants monitored for adverse events related to splint use, including discomfort, tissue irritation, or allergic reactions
Participants may withdraw at any time
All data handled according to confidentiality and privacy guidelines
Significance:
This study will provide evidence on the effectiveness of patient-specific, MODJAW-guided occlusal splints in improving jaw function, reducing bruxism, and increasing patient satisfaction. The results may support the adoption of kinematic data in routine occlusal splint design and contribute to personalized dentistry approaches.
