Temporomandibular Joint Dysfunction Syndrome, Chronic Pain
Conditions
Keywords
Pain, Temporomandibular joint disorders, Occlusal adjustment, Therapy, Randomized clinical trial, Mastication, Habitual chewing side, Handedness preference, Jaw asymmetry
Brief summary
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.
Detailed description
* The cause of temporomandibular joint (TMJ) disorders (TMD) remains unknown and therapy is usually empirical. Systematic reviews have concluded that currently there is no evidence that occlusal adjustment has any therapeutic or preventive effect on temporomandibular disorders. However, these reviews also indicate that evidence to the contrary has not been provided and that more research is needed to elucidate whether there is any benefit of occlusal adjustment treatment for TMD. The risk factors for chronic unilateral TMD include a steeper condylar path, flatter lateral anterior guidance, and habitual chewing on the affected side. Consequently, a new occlusal therapy is proposed to restore the physiological jaw closure and masticatory function. * The primary end point of the trial is to assess the efficacy of the new occlusal therapy on the affected side TMD pain, and the maximum mouth opening. Efficacy is demonstrated by showing significantly superior pain relief and increasing maximum mouth opening (when it was limited) with the active treatment compared with placebo. Phase III, single center, randomized, parallel-group, single-blind with blinded assessment, placebo-controlled clinical trial. * A linear mixed model will be performed for comparisons of most variables and a logistic regression model will be used to measure the probability/risk of change on the chewing side between baseline and six months; in addition, McNemar's test may be used. * Interim analysis plan and stopping rules. The study will employ an interim analysis plan with a single interim analysis after 70% of participants have completed the six-month follow-up visit. Using the Lan-DeMets version of the O'Brien-Fleming stopping rule, the critical value for statistical significance at the interim analysis (under intention-to-treat approach) will be +2.438, corresponding to a nominal two-sided P value of 0.0146. 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.
Interventions
PROCEDUREOcclusal 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)
PROCEDUREPlacebo 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.
Sponsors
University of Santiago de Compostela
Urbano Santana Penin, MD, DDS, PhD
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
* Completely dentate (except for the third molars; including if they were treated before enrollment by conventional or implant-supported fixed prosthesis allowing similar potential comfortable chewing on both sides) * Normal Angle Class I occlusion * Self-reported pain-intensity scores from 4 to 9 in a 0-10 visual analogue scale (VAS) or numerical pain rating scale (NRS). * Chronic (over 6 months) joint and/or muscle pain, according to diagnostic criteria for temporomandibular disorders (DC/TMD), for which they had requested therapy
Exclusion criteria
* Psychosis * Major depression * Substance abuse * Cognitive impairment * Addiction to morphine or derivates * Litigation or asking for disability/retirement compensation for chronic pain * Dental care professionals * Orthodontic therapy during the last 2 years * Patients with any pain that is more severe, in the same location as, or cannot be clearly distinguished from TMD pain * Individuals for whom minimally invasive occlusal adjustment could not achieve occlusal equilibration, including: Over 2 mm of difference between the maximal intercuspal position and the centric occlusion or over 4 mm of difference between upper and lower archs (or over 2mm on at less one side) measured: between the mesial fosses of first upper premolars with respect the buccal cusps of the first lower premolars; and/or between the mesiopalatal cusp of the first upper molars respect to the central (mesial) fossae of the first lower molar. * Severe periodontal disease with grade 3 mobility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Jaw-pain-Intensity (Affected Side) | Baseline and 6-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chewing Side | Baseline and 6-months | 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. |
| Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R)) | Baseline, 6-Months | 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). |
| Maximum Unassisted Jaw Opening | Baseline, 3- and 6-Months | Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Condylar Path Angles | Baseline | Parasagittal plane condylar path tracings in relation to the Frankfort Horizontal Plane following the Gysi extraoral method. |
| Adverse Events | After therapy, 1-Month, 3-Months, 6-Months | Unexpected Adverse Events (NIH, 2009). |
| Jaw Asymmetry | Baseline | 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 |
| Participant's Awareness With Trial Group Assignment | Six months | Physicians and patients are quizzed at the end of the study to determine whether or not they have guessed the therapy involved |
| Credibility (of Participants) | Baseline, 6-Months | 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. |
| Sociodemography | Baseline | Level of education |
| Patient Impression (Improvement) | 6-Months | Patient impression outcome will be reported as Improved Vs. no change. |
| Pain Interference on Daily Activity | Baseline; 6-Months | 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. |
| Headache-intensity | Baseline 3- and 6-Months | Headache intensity in recent months (If any) in a 0-10 numerical pain rating scale with 0=no pain and 10= worst possible pain. |
| Temporomandibular Disorders Related Impairment | Baseline, 6-Mo | Mandibular Function Impairment Questionnaire (MFIQ) |
| Circulating Biomarkers | Baseline, 6-Months | Blood levels of Circulating Biomarkers |
| Periodontal Disease (if Indicated) | Baseline, 6-Months | Radiographic defect, Probing depth, Clinical attachment level, Tooth mobility Tooth mobility |
| Occlusal Forces/Pressure | Baseline; 6-Months | Dental or occlusal forces measured using fuji-film method. |
| Maximum Comfortable (Without Pain) Jaw Opening | Baseline, immediate after therapy, 3- and 6-Months | Vertical jaw-opening (incisal level) measured using a ruler. |
| Patient's Perception of Reduced Movement | Baseline, 6-Months | Subjective patient's perception of reduced jaw-opening; how many fingers can put between your incisors?. Higher values represent a better outcome. |
| Protrusive Motion | Baseline, 6-Months | 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. |
| Pain-dimensions | Baseline, 6-Months | McGill Pain questionnaire |
| Number of Participants With Neuropathic Pain | Baseline, 6-Months | Neuropathic pain Questionnaire (DN4). Over 4 scores indicates neuropathic facial pain. |
| Handedness Preference | Baseline | Handedness preference assessed using Edinburg inventory: Left Right 1. Writing 2. Drawing 3. Throwing 4. Scissors 5. Toothbrush 6. Knife (without fork) 7. Spoon 8. Broom (upper hand) 9. Striking Match (match) 10. Opening box (lid) I Which foot do you prefer to kick with? II Which eye do you use when using only one? |
| Lateral Guidance Angles (LG) | Baseline | 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 39 |
| 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. | 38 |
| Total | 77 |
Baseline characteristics
| Characteristic | Occlusal Adjustmen Therapy | Total | Placebo Occlusal Adjustment Therapy |
|---|---|---|---|
| Age, Continuous | 29 years | 30 years | 30 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 74 Participants | 36 Participants |
| Self-reported jaw-pain intensity | 7 units on a 0-10 scale | 7 units on a 0-10 scale | 7 units on a 0-10 scale |
| Sex: Female, Male Female | 37 Participants | 72 Participants | 35 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 38 |
| other Total, other adverse events | 3 / 39 | 0 / 38 |
| serious Total, serious adverse events | 0 / 39 | 0 / 38 |
Outcome results
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.
Time frame: Baseline and 6-months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Occlusal Adjustmen Therapy | Jaw-pain-Intensity (Affected Side) | baseline | 7 units on a scale |
| Occlusal Adjustmen Therapy | Jaw-pain-Intensity (Affected Side) | 6-Months | 2 units on a scale |
| Placebo Occlusal Adjustment Therapy | Jaw-pain-Intensity (Affected Side) | baseline | 7 units on a scale |
| Placebo Occlusal Adjustment Therapy | Jaw-pain-Intensity (Affected Side) | 6-Months | 3.5 units on a scale |
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).
Time frame: Baseline, 6-Months
Population: Some self administered questionnaire was not adequately covered by the patient.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Occlusal Adjustmen Therapy | Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R)) | baseline | 0.89 score on a scale | Standard Deviation 0.57 |
| Occlusal Adjustmen Therapy | Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R)) | 6-Months | 0.52 score on a scale | Standard Deviation 0.5 |
| Placebo Occlusal Adjustment Therapy | Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R)) | baseline | 0.81 score on a scale | Standard Deviation 0.51 |
| Placebo Occlusal Adjustment Therapy | Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R)) | 6-Months | 0.5 score on a scale | Standard Deviation 0.49 |
p-value: 0.54Mixed Models Analysis
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.
Time frame: Baseline and 6-months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Occlusal Adjustmen Therapy | Chewing Side | baseline | Right | 16 Participants |
| Occlusal Adjustmen Therapy | Chewing Side | baseline | Alternate | 8 Participants |
| Occlusal Adjustmen Therapy | Chewing Side | baseline | Left | 15 Participants |
| Occlusal Adjustmen Therapy | Chewing Side | 6-Months | Right | 6 Participants |
| Occlusal Adjustmen Therapy | Chewing Side | 6-Months | Alternate | 25 Participants |
| Occlusal Adjustmen Therapy | Chewing Side | 6-Months | Left | 8 Participants |
| Placebo Occlusal Adjustment Therapy | Chewing Side | 6-Months | Alternate | 27 Participants |
| Placebo Occlusal Adjustment Therapy | Chewing Side | baseline | Right | 14 Participants |
| Placebo Occlusal Adjustment Therapy | Chewing Side | 6-Months | Right | 6 Participants |
| Placebo Occlusal Adjustment Therapy | Chewing Side | baseline | Alternate | 13 Participants |
| Placebo Occlusal Adjustment Therapy | Chewing Side | 6-Months | Left | 5 Participants |
| Placebo Occlusal Adjustment Therapy | Chewing Side | baseline | Left | 11 Participants |
Secondary
Maximum Unassisted Jaw Opening
Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome.
Time frame: Baseline, 3- and 6-Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Occlusal Adjustmen Therapy | Maximum Unassisted Jaw Opening | baseline | 41.5 mm | Standard Deviation 8.4 |
| Occlusal Adjustmen Therapy | Maximum Unassisted Jaw Opening | 3-Months | 45.66 mm | Standard Deviation 7.9 |
| Occlusal Adjustmen Therapy | Maximum Unassisted Jaw Opening | 6-Months | 47.7 mm | Standard Deviation 8.4 |
| Placebo Occlusal Adjustment Therapy | Maximum Unassisted Jaw Opening | baseline | 43.9 mm | Standard Deviation 7.8 |
| Placebo Occlusal Adjustment Therapy | Maximum Unassisted Jaw Opening | 3-Months | 46.73 mm | Standard Deviation 7.7 |
| Placebo Occlusal Adjustment Therapy | Maximum Unassisted Jaw Opening | 6-Months | 46.4 mm | Standard Deviation 7.7 |
Other Pre-specified
Adverse Events
Unexpected Adverse Events (NIH, 2009).
Time frame: After therapy, 1-Month, 3-Months, 6-Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Occlusal Adjustmen Therapy | Adverse Events | 0 Participants |
| Placebo Occlusal Adjustment Therapy | Adverse Events | 0 Participants |
Other Pre-specified
Circulating Biomarkers
Blood levels of Circulating Biomarkers
Time frame: Baseline, 6-Months
Other Pre-specified
Condylar Path Angles
Parasagittal plane condylar path tracings in relation to the Frankfort Horizontal Plane following the Gysi extraoral method.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Occlusal Adjustmen Therapy | Condylar Path Angles | right joint | 50.5 degrees | Standard Deviation 10.7 |
| Occlusal Adjustmen Therapy | Condylar Path Angles | left joint | 50.1 degrees | Standard Deviation 10.5 |
| Placebo Occlusal Adjustment Therapy | Condylar Path Angles | right joint | 47.3 degrees | Standard Deviation 8.1 |
| Placebo Occlusal Adjustment Therapy | Condylar Path Angles | left joint | 49.3 degrees | Standard Deviation 8.6 |
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.
Time frame: Baseline, 6-Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Occlusal Adjustmen Therapy | Credibility (of Participants) | baseline | 8 units on a scale | Standard Deviation 1.8 |
| Occlusal Adjustmen Therapy | Credibility (of Participants) | 6-Months | 8 units on a scale | Standard Deviation 1.9 |
| Placebo Occlusal Adjustment Therapy | Credibility (of Participants) | baseline | 8.3 units on a scale | Standard Deviation 1.3 |
| Placebo Occlusal Adjustment Therapy | Credibility (of Participants) | 6-Months | 7.6 units on a scale | Standard Deviation 2.6 |
Other Pre-specified
Handedness Preference
Handedness preference assessed using Edinburg inventory: Left Right 1. Writing 2. Drawing 3. Throwing 4. Scissors 5. Toothbrush 6. Knife (without fork) 7. Spoon 8. Broom (upper hand) 9. Striking Match (match) 10. Opening box (lid) I Which foot do you prefer to kick with? II Which eye do you use when using only one?
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Occlusal Adjustmen Therapy | Handedness Preference | right | 29 Participants |
| Occlusal Adjustmen Therapy | Handedness Preference | left | 10 Participants |
| Placebo Occlusal Adjustment Therapy | Handedness Preference | right | 31 Participants |
| Placebo Occlusal Adjustment Therapy | Handedness Preference | left | 7 Participants |
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.
Time frame: Baseline 3- and 6-Months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Occlusal Adjustmen Therapy | Headache-intensity | baseline | 7 score on a scale |
| Occlusal Adjustmen Therapy | Headache-intensity | 3-Months | 4 score on a scale |
| Occlusal Adjustmen Therapy | Headache-intensity | 6-Months | 4 score on a scale |
| Placebo Occlusal Adjustment Therapy | Headache-intensity | baseline | 5.75 score on a scale |
| Placebo Occlusal Adjustment Therapy | Headache-intensity | 3-Months | 3 score on a scale |
| Placebo Occlusal Adjustment Therapy | Headache-intensity | 6-Months | 3 score on a scale |
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
Time frame: 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.
Time frame: Baseline
Population: Note that both sides of each participant was assessed. Recordings from one participant in each group are unavailable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Occlusal Adjustmen Therapy | Lateral Guidance Angles (LG) | 42 degrees | Standard Deviation 10.3 |
| Placebo Occlusal Adjustment Therapy | Lateral Guidance Angles (LG) | 40.6 degrees | Standard Deviation 11.8 |
Other Pre-specified
Maximum Comfortable (Without Pain) Jaw Opening
Vertical jaw-opening (incisal level) measured using a ruler.
Time frame: Baseline, immediate after therapy, 3- and 6-Months
Other Pre-specified
Number of Participants With Neuropathic Pain
Neuropathic pain Questionnaire (DN4). Over 4 scores indicates neuropathic facial pain.
Time frame: Baseline, 6-Months
Population: Data from 1 placebo group participant at 6-months not available
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Occlusal Adjustmen Therapy | Number of Participants With Neuropathic Pain | baseline | neuropathic pain | 13 Participants |
| Occlusal Adjustmen Therapy | Number of Participants With Neuropathic Pain | baseline | without neuropathic symptoms | 26 Participants |
| Occlusal Adjustmen Therapy | Number of Participants With Neuropathic Pain | at month 6 | neuropathic pain | 3 Participants |
| Occlusal Adjustmen Therapy | Number of Participants With Neuropathic Pain | at month 6 | without neuropathic symptoms | 36 Participants |
| Placebo Occlusal Adjustment Therapy | Number of Participants With Neuropathic Pain | at month 6 | without neuropathic symptoms | 33 Participants |
| Placebo Occlusal Adjustment Therapy | Number of Participants With Neuropathic Pain | baseline | neuropathic pain | 12 Participants |
| Placebo Occlusal Adjustment Therapy | Number of Participants With Neuropathic Pain | at month 6 | neuropathic pain | 4 Participants |
| Placebo Occlusal Adjustment Therapy | Number of Participants With Neuropathic Pain | baseline | without neuropathic symptoms | 25 Participants |
Other Pre-specified
Occlusal Forces/Pressure
Dental or occlusal forces measured using fuji-film method.
Time frame: Baseline; 6-Months
Other Pre-specified
Pain-dimensions
McGill Pain questionnaire
Time frame: Baseline, 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.
Time frame: Baseline; 6-Months
Population: Data from two occlusal adjustment and six placebo group participants were not available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Occlusal Adjustmen Therapy | Pain Interference on Daily Activity | baseline | 5.2 units on a scale | Standard Deviation 2.6 |
| Occlusal Adjustmen Therapy | Pain Interference on Daily Activity | 6-Months | 3.1 units on a scale | Standard Deviation 2.6 |
| Placebo Occlusal Adjustment Therapy | Pain Interference on Daily Activity | baseline | 4.5 units on a scale | Standard Deviation 2.9 |
| Placebo Occlusal Adjustment Therapy | Pain Interference on Daily Activity | 6-Months | 2 units on a scale | Standard Deviation 3.2 |
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
Time frame: Six months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Occlusal Adjustmen Therapy | Participant's Awareness With Trial Group Assignment | real therapy | 26 Participants |
| Occlusal Adjustmen Therapy | Participant's Awareness With Trial Group Assignment | I don't' know | 12 Participants |
| Occlusal Adjustmen Therapy | Participant's Awareness With Trial Group Assignment | placebo therapy | 1 Participants |
| Placebo Occlusal Adjustment Therapy | Participant's Awareness With Trial Group Assignment | real therapy | 21 Participants |
| Placebo Occlusal Adjustment Therapy | Participant's Awareness With Trial Group Assignment | I don't' know | 14 Participants |
| Placebo Occlusal Adjustment Therapy | Participant's Awareness With Trial Group Assignment | placebo therapy | 3 Participants |
Other Pre-specified
Patient Impression (Improvement)
Patient impression outcome will be reported as Improved Vs. no change.
Time frame: 6-Months
Population: Data from two participants in placebo group that underwent randomization were not available.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Occlusal Adjustmen Therapy | Patient Impression (Improvement) | No change | 2 Participants |
| Occlusal Adjustmen Therapy | Patient Impression (Improvement) | Improved | 37 Participants |
| Placebo Occlusal Adjustment Therapy | Patient Impression (Improvement) | No change | 11 Participants |
| Placebo Occlusal Adjustment Therapy | Patient Impression (Improvement) | Improved | 25 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.
Time frame: Baseline, 6-Months
Other Pre-specified
Periodontal Disease (if Indicated)
Radiographic defect, Probing depth, Clinical attachment level, Tooth mobility Tooth mobility
Time frame: Baseline, 6-Months
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.
Time frame: Baseline, 6-Months
Other Pre-specified
Sociodemography
Level of education
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Occlusal Adjustmen Therapy | Sociodemography | Higher | 21 Participants |
| Occlusal Adjustmen Therapy | Sociodemography | Secondary | 12 Participants |
| Occlusal Adjustmen Therapy | Sociodemography | No qualifications | 6 Participants |
| Placebo Occlusal Adjustment Therapy | Sociodemography | Higher | 26 Participants |
| Placebo Occlusal Adjustment Therapy | Sociodemography | Secondary | 9 Participants |
| Placebo Occlusal Adjustment Therapy | Sociodemography | No qualifications | 3 Participants |
Other Pre-specified
Temporomandibular Disorders Related Impairment
Mandibular Function Impairment Questionnaire (MFIQ)
Time frame: Baseline, 6-Mo