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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.
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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occlusal adjustment | Procedure | modification of occlusal surfaces |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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" | Baseline, immediately after therapy, 3 months and 6 months after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before and 6 months after therapy |
| Preferred Chewing Side |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José López-Cedrún Cembranos, MD, DDS, PhD | Complejo Hospitalario Universitario de La Coruña | Principal Investigator |
| Urbano Santana Penín, MD, DDS, PhD | Universidad de Santiago de Compostela | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de La Coruña | A Coruña | La Coruña | 15006 | Spain | ||
| Facultad de Medicina y Odontología |
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| ID | Title | Description |
|---|---|---|
| FG000 | Real Occlusal Adjustment | Occlusal adjustment : modification of occlusal surfaces |
| FG001 | Sham Occlusal Adjustment | Placebo occlusal adjustment : Simulated modification of occlusal surfaces |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Real Occlusal Adjustment | |
| BG001 | Sham Occlusal Adjustment | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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" | Posted | Mean | Standard Deviation | units on a scale | Baseline, immediately after therapy, 3 months and 6 months after therapy |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Real Occlusal Adjustment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Urbano Santana Penín | University of Santiago de Compostela | 0034647344093 | urbano.santana@usc.es |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D005157 | Facial Pain |
| D002012 | Bruxism |
| D013706 | Temporomandibular Joint Dysfunction Syndrome |
| D010146 | Pain |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019558 | Occlusal Adjustment |
| ID | Term |
|---|---|
| D009971 | Orthodontics, Corrective |
| D009970 | Orthodontics |
| D003813 | Dentistry |
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| Placebo occlusal adjustment | Procedure | Simulated modification of occlusal surfaces |
|
The change in the habitual chewing side of each participant across the study
| Before and 6 months after therapy |
| Maximum Mouth Opening (mm) | Maximum voluntary unassisted mouth opening | 6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up |
| Condylar Path Angles | Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method. | Baseline |
| Santiago de Compostela |
| La Coruña |
| 15782 |
| Spain |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. | Only tests from 15 participants were suitable because of slow or too many positive responses. | Posted | Mean | Standard Deviation | units on a scale | Before and 6 months after therapy |
|
|
|
| Secondary | Preferred Chewing Side | The change in the habitual chewing side of each participant across the study | Posted | Number | participants | Before and 6 months after therapy |
|
|
|
| Secondary | Maximum Mouth Opening (mm) | Maximum voluntary unassisted mouth opening | Posted | Mean | Standard Deviation | mm | 6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up |
|
|
|
| Secondary | Condylar Path Angles | Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method. | Posted | Mean | Standard Deviation | degrees | Baseline |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Sham Occlusal Adjustment | 0 | 11 | 0 | 11 |
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| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014076 | Tooth Diseases |
| D006184 | Habits |
| D001519 | Behavior |
| D009209 | Myofascial Pain Syndromes |
| 3 months after therapy |
|
| 6 months after therapy |
|
| Pain side condylar path angle |
|
| Non-pain side condylar path angle |
|