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| ID | Type | Description | Link |
|---|---|---|---|
| PI11/02507 | Other Grant/Funding Number | Ministry of Science and Innovation (Spain) | |
| ISRCTN | Registry Identifier | 61654487 |
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Interim analysis showed benefice of one therapy over the other one.
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| Name | Class |
|---|---|
| University of Santiago de Compostela | OTHER |
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The primary endpoint will be the average change in pain score from baseline to the three- and six-month assessments. Efficacy will be demonstrated by superior pain relief with the active treatment compared with the placebo.
Phase III, single center, randomized, parallel-group, single-blind with blinded assessment, placebo-controlled clinical trial.
Participants remaining with significant pain (and/or limited mouth opening) after the study will be invited to follow the conventional treatment, or to "complete" occlusal adjustment (rescue therapy): the full adjustment (if they were placebos), or a refining (if they received real therapy); the kind of received therapy will not be disclosed to participants. It based on the researchers' conviction, participants are encouraged to receive electively "complete" occlusal adjustment. All participants will be reevaluated between 3 to 6 months after study (12-Mo follow-up). Although no pain was reported at the 6-Mo follow-up, if pain returns, same approach will be carried out. Two sessions occlusal adjustment will be carried out and, if the pain remains, the patient will be treated following the Hospital approaches. The evolution of patients during post-MAP period, until writing of the manuscript, will be reported in the same manuscript, even if MAP result early stopped.
Additional patient's monitoring until next five years after treatment is expected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occlusal adjustment therapy | Experimental | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. |
|
| Placebo occlusal adjustment therapy | Placebo Comparator | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occlusal adjustment | Procedure | The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) |
| Measure | Description | Time Frame |
|---|---|---|
| Jaw-pain-Intensity (Affected Side) | Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome. | Baseline and 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Chewing Side | A consistent chewing side was considered if at lees 5 out of 7 almonds (or at lees 7 of 10 cycles of chewing gum), the participant report to use same side, and same side was used during kinesiography recordings of spontaneous chewing. Any other results lead to alternate chewing allocation. | Baseline and 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Headache-intensity | Headache intensity in recent months (If any) in a 0-10 numerical pain rating scale with 0=no pain and 10= worst possible pain. | Baseline 3- and 6-Months |
| Number of Participants With Neuropathic Pain |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Urbano Santana-Penin, Prof | University of Santiago de Compostela | Principal Investigator |
| Jose Lopez-Cedrun, Dr | University Hospital Complex of La Coruña | Study Chair |
| Maria J Mora, Prof | University of Santiago de Compostela | Study Director |
| Urbano Santana-Mora, Dr | University of Santiago de Compostela | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Santiago de Compostela | Santiago de Compostela | A Coruña, Galicia | 15782 | Spain | ||
| Complexo Hospitalario Universitario A Coruña |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23593156 | Background | Santana-Mora U, Lopez-Cedrun J, Mora MJ, Otero XL, Santana-Penin U. Temporomandibular disorders: the habitual chewing side syndrome. PLoS One. 2013 Apr 8;8(4):e59980. doi: 10.1371/journal.pone.0059980. Print 2013. |
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A closed, certificate, database called OpenClinica allows access to members of the Data and Safety Monitoring Board.
We expect to publish raw data in Sci Data. Figures from participant's mouth could be posted in a repository. The protocol will be attached as a supplementary appendix to the main manuscript
The raw data of each participant, unidentifiable, will be accessible within 6 months after the publication of the manuscript and will be accessible for at least one year.
Free access
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| ID | Title | Description |
|---|---|---|
| FG000 | Occlusal Adjustmen Therapy | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) |
| FG001 | Placebo Occlusal Adjustment Therapy | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Occlusal Adjustmen Therapy | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter lateral guidance angle on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Jaw-pain-Intensity (Affected Side) | Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 6-months |
|
6 months
The dental hypersensitivity period (referred to as discomfort to the chewing foods crisp) lasted between 1 and 3 months.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Occlusal Adjustmen Therapy | Occlusal adjustment therapy consists of the elimination of premature tooth contacts during retruded jaw closure, and the reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance). A resin-composite, placed mainly in the canine tooth, can be used to increases the flatter LG on the habitual chewing side; overcorrection is expected to compensate for a masticatory preference on the opposite side to the handedness. Occlusal adjustment: The first step consists of the elimination of premature tooth contacts during retruded jaw closure. The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental hypersensitivity | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dental hypersensitivity, treated using topic fluorides |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Urbano Santana Penín | University of Santiago de Compostela. A Coruña. SPAIN | +34647344093 | urbano.santana@usc.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2017 | Mar 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013706 | Temporomandibular Joint Dysfunction Syndrome |
| D059350 | Chronic Pain |
| D010146 | Pain |
| D013705 | Temporomandibular Joint Disorders |
| 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 | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
|
| Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R)) |
Mean change in Global Severity Index scores from a self-administered Spanish validated questionaire SCL-90-R. Higher values represent a worse outcome. Range (0-4). |
| Baseline, 6-Months |
| Maximum Unassisted Jaw Opening | Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome. | Baseline, 3- and 6-Months |
Neuropathic pain Questionnaire (DN4). Over 4 scores indicates neuropathic facial pain.
| Baseline, 6-Months |
| Handedness Preference | Handedness preference assessed using Edinburg inventory: Left Right
| Baseline |
| Lateral Guidance Angles (LG) | The angle between the tangent of the LG tracings and the horizontal Frankfort line, starting from the midsagittal point up 2 mm: using a calibrated Model K7 diagnostic system. Both sides recordings of each patient were measured and considered individually. The mean of both sides of each patient was not used. | Baseline |
| Condylar Path Angles | Parasagittal plane condylar path tracings in relation to the Frankfort Horizontal Plane following the Gysi extraoral method. | Baseline |
| Adverse Events | Unexpected Adverse Events (NIH, 2009). | After therapy, 1-Month, 3-Months, 6-Months |
| Jaw Asymmetry | Over 1 mm of interincisal midline deviation and inter-arches Angle Classification of the lateral sectors (canines and first molars); it will be assessed during maximal intercuspal position and during jaw retruded contact position | Baseline |
| Participant's Awareness With Trial Group Assignment | Physicians and patients are quizzed at the end of the study to determine whether or not they have guessed the therapy involved | Six months |
| Credibility (of Participants) | Confidence of participants in the goodness of treatment. These items were simplified here to the following single question: How confident would you be that this treatment would be successful in eliminating your pain and/or limited mouth opening? 0-10 numerical rating scale, with 0=nothing to 10= totally. | Baseline, 6-Months |
| Sociodemography | Level of education | Baseline |
| Patient Impression (Improvement) | Patient impression outcome will be reported as Improved Vs. no change. | 6-Months |
| Pain Interference on Daily Activity | In the past 6 months, how much has facial pain interfered with your daily activities rated on a 0-10 scale where 0 is "no interference" and 10 is "unable to carry on any activities"? 0-10 VAS/NRS (0=No interference to 10=Unable to carry on any activities). N.B. Only one item was choose to simplify. | Baseline; 6-Months |
| Pain-dimensions | McGill Pain questionnaire | Baseline, 6-Months |
| Temporomandibular Disorders Related Impairment | Mandibular Function Impairment Questionnaire (MFIQ) | Baseline, 6-Mo |
| Circulating Biomarkers | Blood levels of Circulating Biomarkers | Baseline, 6-Months |
| Periodontal Disease (if Indicated) | Radiographic defect, Probing depth, Clinical attachment level, Tooth mobility Tooth mobility | Baseline, 6-Months |
| Occlusal Forces/Pressure | Dental or occlusal forces measured using fuji-film method. | Baseline; 6-Months |
| Maximum Comfortable (Without Pain) Jaw Opening | Vertical jaw-opening (incisal level) measured using a ruler. | Baseline, immediate after therapy, 3- and 6-Months |
| Patient's Perception of Reduced Movement | Subjective patient's perception of reduced jaw-opening; how many fingers can put between your incisors?. Higher values represent a better outcome. | Baseline, 6-Months |
| Protrusive Motion | Magnitude (mm) of protrusive jaw-movement (incisal level) and lateral shift (quantitative, mm; and/or qualitative, left/right), using kinesiography recordings. Higher values represent a better outcome. | Baseline, 6-Months |
| A Coruña |
| A Coruña. Galicia |
| 15006 |
| Spain |
| BG001 | Placebo Occlusal Adjustment Therapy | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Self-reported jaw-pain intensity | Self-reported pain-intensity on the affected side measured by the Visual Analogue Scale (VAS) and/or Numerical Pain Rating Scale (NRS). We will work with a 0-10 scale, with 0 indicating no-pain and 10 the worst possible pain. | Median | Inter-Quartile Range | units on a 0-10 scale |
|
| OG001 | Placebo Occlusal Adjustment Therapy | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. |
|
|
| Secondary | Chewing Side | A consistent chewing side was considered if at lees 5 out of 7 almonds (or at lees 7 of 10 cycles of chewing gum), the participant report to use same side, and same side was used during kinesiography recordings of spontaneous chewing. Any other results lead to alternate chewing allocation. | Posted | Count of Participants | Participants | Baseline and 6-months |
|
|
|
| Secondary | Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R)) | Mean change in Global Severity Index scores from a self-administered Spanish validated questionaire SCL-90-R. Higher values represent a worse outcome. Range (0-4). | Some self administered questionnaire was not adequately covered by the patient. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-Months |
|
|
|
|
| Secondary | Maximum Unassisted Jaw Opening | Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome. | Posted | Mean | Standard Deviation | mm | Baseline, 3- and 6-Months |
|
|
|
| Other Pre-specified | Headache-intensity | Headache intensity in recent months (If any) in a 0-10 numerical pain rating scale with 0=no pain and 10= worst possible pain. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline 3- and 6-Months |
|
|
|
| Other Pre-specified | Number of Participants With Neuropathic Pain | Neuropathic pain Questionnaire (DN4). Over 4 scores indicates neuropathic facial pain. | Data from 1 placebo group participant at 6-months not available | Posted | Count of Participants | Participants | Baseline, 6-Months |
|
|
|
| Other Pre-specified | Handedness Preference | Handedness preference assessed using Edinburg inventory: Left Right
| Posted | Count of Participants | Participants | Baseline |
|
|
|
| Other Pre-specified | Lateral Guidance Angles (LG) | The angle between the tangent of the LG tracings and the horizontal Frankfort line, starting from the midsagittal point up 2 mm: using a calibrated Model K7 diagnostic system. Both sides recordings of each patient were measured and considered individually. The mean of both sides of each patient was not used. | Note that both sides of each participant was assessed. Recordings from one participant in each group are unavailable. | Posted | Mean | Standard Deviation | degrees | Baseline | LG | LG |
|
|
|
| Other Pre-specified | Condylar Path Angles | Parasagittal plane condylar path tracings in relation to the Frankfort Horizontal Plane following the Gysi extraoral method. | Posted | Mean | Standard Deviation | degrees | Baseline |
|
|
|
| Other Pre-specified | Adverse Events | Unexpected Adverse Events (NIH, 2009). | Posted | Count of Participants | Participants | After therapy, 1-Month, 3-Months, 6-Months |
|
|
|
| Other Pre-specified | Jaw Asymmetry | Over 1 mm of interincisal midline deviation and inter-arches Angle Classification of the lateral sectors (canines and first molars); it will be assessed during maximal intercuspal position and during jaw retruded contact position | Not Posted | Baseline | Participants |
| Other Pre-specified | Participant's Awareness With Trial Group Assignment | Physicians and patients are quizzed at the end of the study to determine whether or not they have guessed the therapy involved | Posted | Count of Participants | Participants | Six months |
|
|
|
| Other Pre-specified | Credibility (of Participants) | Confidence of participants in the goodness of treatment. These items were simplified here to the following single question: How confident would you be that this treatment would be successful in eliminating your pain and/or limited mouth opening? 0-10 numerical rating scale, with 0=nothing to 10= totally. | Data from one participant from each group was lost from baseline, and 2 from the Occlusal adjustment group and 5 from the placebo group at 6-months. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6-Months |
|
|
|
| Other Pre-specified | Sociodemography | Level of education | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Other Pre-specified | Patient Impression (Improvement) | Patient impression outcome will be reported as Improved Vs. no change. | Data from two participants in placebo group that underwent randomization were not available. | Posted | Count of Participants | Participants | 6-Months |
|
|
|
| Other Pre-specified | Pain Interference on Daily Activity | In the past 6 months, how much has facial pain interfered with your daily activities rated on a 0-10 scale where 0 is "no interference" and 10 is "unable to carry on any activities"? 0-10 VAS/NRS (0=No interference to 10=Unable to carry on any activities). N.B. Only one item was choose to simplify. | Data from two occlusal adjustment and six placebo group participants were not available. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 6-Months |
|
|
|
| Other Pre-specified | Pain-dimensions | McGill Pain questionnaire | Not Posted | Baseline, 6-Months | Participants |
| Other Pre-specified | Temporomandibular Disorders Related Impairment | Mandibular Function Impairment Questionnaire (MFIQ) | Not Posted | Baseline, 6-Mo | Participants |
| Other Pre-specified | Circulating Biomarkers | Blood levels of Circulating Biomarkers | Not Posted | Baseline, 6-Months | Participants |
| Other Pre-specified | Periodontal Disease (if Indicated) | Radiographic defect, Probing depth, Clinical attachment level, Tooth mobility Tooth mobility | Not Posted | Baseline, 6-Months | Participants |
| Other Pre-specified | Occlusal Forces/Pressure | Dental or occlusal forces measured using fuji-film method. | Not Posted | Baseline; 6-Months | Participants |
| Other Pre-specified | Maximum Comfortable (Without Pain) Jaw Opening | Vertical jaw-opening (incisal level) measured using a ruler. | Not Posted | Baseline, immediate after therapy, 3- and 6-Months | Participants |
| Other Pre-specified | Patient's Perception of Reduced Movement | Subjective patient's perception of reduced jaw-opening; how many fingers can put between your incisors?. Higher values represent a better outcome. | Not Posted | Baseline, 6-Months | Participants |
| Other Pre-specified | Protrusive Motion | Magnitude (mm) of protrusive jaw-movement (incisal level) and lateral shift (quantitative, mm; and/or qualitative, left/right), using kinesiography recordings. Higher values represent a better outcome. | Not Posted | Baseline, 6-Months | Participants |
| 0 |
| 39 |
| 0 |
| 39 |
| 3 |
| 39 |
| EG001 | Placebo Occlusal Adjustment Therapy | Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. Placebo occlusal adjustment: Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed. | 0 | 38 | 0 | 38 | 0 | 38 |
|
Not provided
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| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009209 | Myofascial Pain Syndromes |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Left |
|
| 6-Months |
|
| 6-Months |
|
|
| 6-Months |
|
| 6-Months |
|
| at month 6 |
|
| placebo therapy |
|
| No qualifications |
|