Temporomandibular Joint Disorders, Orofacial Pain
Conditions
Keywords
Temporomandibular Joint Disorders (TMD), Orofacial pain, Limited mouth opening, Craniomandibular dysfunction syndrome, Axiography, Gnatography, Preferred chewing side, Occlusal adjustment, Selective grinding, Handedness, Bruxism, TMD, Costen's Syndrome, Myofascial pain, TMD treatment, Pain
Brief summary
The purpose of this study is to determine whether occlusal adjustment by selective grinding and/or occlusal addition is an effective treatment of chronic temporomandibular joint disorders.
Detailed description
Temporomandibular disorders (TMD) are very common disorders in daily dentistry and oral and maxillofacial practice. The key symptoms are jaw joint pain and limited mouth opening. Other than trauma, the causes remain unknown; consequently, there are no treatments based on specific etiologies. In our experience, patients can usually receive beneficial occlusal adjustments if these are carefully planned and performed in two steps: (1) elimination of premature contacts, which reduces loads in the temporomandibular joints, and (2) individualized remodeling of lateral anterior guidance to facilitate unilateral alternate chewing. The study will use stratified blocking randomization to blindly assign patients to the real or placebo treatment groups in order to evaluate the null hypothesis (H0) that Occlusal adjustment of sufficient quality has no effect on chronic pain and/or limited mouth opening in TMD patients.
Interventions
PROCEDUREOcclusal adjustment
modification of occlusal surfaces
PROCEDUREPlacebo occlusal adjustment
Simulated modification of occlusal surfaces
Sponsors
University of Santiago de Compostela
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* People suitable for inclusion in the study are full dentate patients * Aged between 18 and 65 years * Patients with chronic TMD pain (and usually with associated limited mouth opening) for whom occlusal adjustment could achieve normal occlusion, both static and functionally equilibrated
Exclusion criteria
* Pregnancy * Trauma * Previous TMJ surgery * Patient refusal to consent to participate in the study or significant concerns about the study * Limited collaboration * Concurrent active treatment with orthodontics, and active periodontal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogic Scale for Pain Intensity (0-10) | Baseline, immediately after therapy, 3 months and 6 months after therapy | The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0=No pain and 10=Worst imaginable pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Checklist-90-Revised (SCL-90-R®) | Before and 6 months after therapy | Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases. |
| Preferred Chewing Side | Before and 6 months after therapy | The change in the habitual chewing side of each participant across the study |
| Maximum Mouth Opening (mm) | 6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up | Maximum voluntary unassisted mouth opening |
| Condylar Path Angles | Baseline | Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Real Occlusal Adjustment | 10 |
| Sham Occlusal Adjustment | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Sham Occlusal Adjustment | Real Occlusal Adjustment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 10 Participants | 21 Participants |
| Age Continuous | 29.73 years STANDARD_DEVIATION 8.61 | 34.7 years STANDARD_DEVIATION 13.7 | 32.1 years STANDARD_DEVIATION 11.34 |
| Region of Enrollment Spain | 11 participants | 10 participants | 21 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
Primary
Visual Analogic Scale for Pain Intensity (0-10)
The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0=No pain and 10=Worst imaginable pain
Time frame: Baseline, immediately after therapy, 3 months and 6 months after therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real Occlusal Adjustment | Visual Analogic Scale for Pain Intensity (0-10) | Baseline | 6.52 units on a scale | Standard Deviation 1.84 |
| Real Occlusal Adjustment | Visual Analogic Scale for Pain Intensity (0-10) | Immediately after therapy | .81 units on a scale | Standard Deviation 1.56 |
| Real Occlusal Adjustment | Visual Analogic Scale for Pain Intensity (0-10) | 3 months after therapy | 2.25 units on a scale | Standard Deviation 2.68 |
| Real Occlusal Adjustment | Visual Analogic Scale for Pain Intensity (0-10) | 6 months after therapy | .40 units on a scale | Standard Deviation 0.97 |
| Placebo Occlusal Adjustment | Visual Analogic Scale for Pain Intensity (0-10) | 6 months after therapy | 4 units on a scale | Standard Deviation 2.31 |
| Placebo Occlusal Adjustment | Visual Analogic Scale for Pain Intensity (0-10) | Baseline | 4.8 units on a scale | Standard Deviation 1.99 |
| Placebo Occlusal Adjustment | Visual Analogic Scale for Pain Intensity (0-10) | 3 months after therapy | 3.80 units on a scale | Standard Deviation 2.94 |
| Placebo Occlusal Adjustment | Visual Analogic Scale for Pain Intensity (0-10) | Immediately after therapy | 2.05 units on a scale | Standard Deviation 2.07 |
Secondary
Condylar Path Angles
Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real Occlusal Adjustment | Condylar Path Angles | Right condylar path angle | 52.33 degrees | Standard Deviation 10.28 |
| Real Occlusal Adjustment | Condylar Path Angles | Left condylar path angle | 49.20 degrees | Standard Deviation 11.68 |
| Real Occlusal Adjustment | Condylar Path Angles | Pain side condylar path angle | 56.75 degrees | Standard Deviation 12.62 |
| Real Occlusal Adjustment | Condylar Path Angles | Non-pain side condylar path angle | 44.78 degrees | Standard Deviation 6.87 |
| Placebo Occlusal Adjustment | Condylar Path Angles | Non-pain side condylar path angle | 46.18 degrees | Standard Deviation 8.36 |
| Placebo Occlusal Adjustment | Condylar Path Angles | Right condylar path angle | 49 degrees | Standard Deviation 8.09 |
| Placebo Occlusal Adjustment | Condylar Path Angles | Pain side condylar path angle | 51.09 degrees | Standard Deviation 9.31 |
| Placebo Occlusal Adjustment | Condylar Path Angles | Left condylar path angle | 48.27 degrees | Standard Deviation 10.21 |
Secondary
Maximum Mouth Opening (mm)
Maximum voluntary unassisted mouth opening
Time frame: 6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real Occlusal Adjustment | Maximum Mouth Opening (mm) | Baseline | 41.6 mm | Standard Deviation 8.26 |
| Real Occlusal Adjustment | Maximum Mouth Opening (mm) | Immediately after therapy | 45.50 mm | Standard Deviation 7.89 |
| Real Occlusal Adjustment | Maximum Mouth Opening (mm) | 3 months after therapy | 47.10 mm | Standard Deviation 5.26 |
| Real Occlusal Adjustment | Maximum Mouth Opening (mm) | 6 months after therapy | 49.20 mm | Standard Deviation 7.28 |
| Placebo Occlusal Adjustment | Maximum Mouth Opening (mm) | 6 months after therapy | 41.73 mm | Standard Deviation 10.34 |
| Placebo Occlusal Adjustment | Maximum Mouth Opening (mm) | Baseline | 42.36 mm | Standard Deviation 10.55 |
| Placebo Occlusal Adjustment | Maximum Mouth Opening (mm) | 3 months after therapy | 41.27 mm | Standard Deviation 11.31 |
| Placebo Occlusal Adjustment | Maximum Mouth Opening (mm) | Immediately after therapy | 45.07 mm | Standard Deviation 10.61 |
Secondary
Preferred Chewing Side
The change in the habitual chewing side of each participant across the study
Time frame: Before and 6 months after therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Real Occlusal Adjustment | Preferred Chewing Side | Baseline | 0 participants |
| Real Occlusal Adjustment | Preferred Chewing Side | 6 months after therapy | 8 participants |
| Placebo Occlusal Adjustment | Preferred Chewing Side | Baseline | 0 participants |
| Placebo Occlusal Adjustment | Preferred Chewing Side | 6 months after therapy | 1 participants |
Secondary
Symptom Checklist-90-Revised (SCL-90-R®)
Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.
Time frame: Before and 6 months after therapy
Population: Only tests from 15 participants were suitable because of slow or too many positive responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real Occlusal Adjustment | Symptom Checklist-90-Revised (SCL-90-R®) | Baseline Global Severity Index | 1.32 units on a scale | Standard Deviation 0.91 |
| Real Occlusal Adjustment | Symptom Checklist-90-Revised (SCL-90-R®) | 6 months after therapy Global Severity Index | 0.75 units on a scale | Standard Deviation 0.5 |
| Placebo Occlusal Adjustment | Symptom Checklist-90-Revised (SCL-90-R®) | Baseline Global Severity Index | 0.58 units on a scale | Standard Deviation 0.54 |
| Placebo Occlusal Adjustment | Symptom Checklist-90-Revised (SCL-90-R®) | 6 months after therapy Global Severity Index | 0.51 units on a scale | Standard Deviation 0.58 |