DOI: 10.5061/dryad.zkh189370
title: Remodeling dental anatomy vs sham therapy for chronic temporomandibular disorders: A placebo-controlled randomized clinical trial

description: Background Evidence regarding the etiology or effective treatments for
 chronic orofacial pain, the majority diagnosed as temporomandibular
 disorder (TMD), is limited.   Purpose To investigate whether
 occlusal equilibration therapy (ET) and decreasing the (higher) angle of
 the lateral guidance on the nonworking-side leads to a reduction in
 chronic TMDs intensity.   Methods It was conducted a randomized,
 explanatory, single blind with blinded assessment, placebo-controlled
 trial with strong protection against bias involving patients with chronic
 TMDs. Participants were randomly assigned to receive equilibration therapy
 or sham therapy. ET in this study consisted of minimal invasive occlusal
 remodeling to obtain balanced occlusion with reduction of the steeper
 angle of lateral mandibular movement with respect to the Frankfort plane.
 The primary outcome was a change in the pain intensity score (on a 0–10
 point scale, with 0 indicating no pain and 10 the worst possible pain) at
 month 6. Secondary outcomes include maximum unassisted mouth opening and
 psychological distress.   Results A total of 77 participants
 underwent randomization, 39 of whom received ET and 38 sham therapy. The
 trial was stopped early for efficacy, according to preestablished rules
 when 67 participants (n = 34, n = 33, respectively) had completed the
 analysis. At month 6, the mean unadjusted pain intensity score was 2.1 in
 the ET and 3.6 in the sham therapy group (adjusted mean difference, −1.54;
 95% confidence interval [CI] −0.5 to −2.6; P = 0.004; ANCOVA model). The
 mean increase in maximum unassisted mouth opening (main secondary outcome)
 was significantly higher in the real therapy group (adjusted mean
 difference 3.1 mm, 95% CI 0.5–5.7, p = 0.02).   Conclusion ET
 significantly reduced the intensity of facial pain associated with chronic
 TMDs and increased maximum unassisted mouth opening, as compared with sham
 therapy, over the course of 6 months. There were no serious adverse
 events.
description: <i><b>Pain-intensity</b></i> of the affected side will be measured by self-administered questionnaire using a validated visual analogue scale (VAS; 0–10 (0 = no pain, 10 = worst possible pain) (Huskisson, 1974). Time frame: baseline, 3-month and 6-month follow-up. The primary outcome was reduction in the mean intensity of jaw pain from baseline at the 6-month assessment; clinical important differences 1.5 points. <b><i>Maximum unassisted jaw opening</i></b>, using a Boley gauge (including overbite) units mm. Defined as limited if ≤38 mm (females) or ≤40 mm (males) <b><i>Chewing function</i></b> (alternate vs. one habitual chewing side): Clinically observed habitual chewing side: if at least 7/10 almonds are chewed on the same side (Paphangkorakit  et al., 2006); (or) the side where the chewing-gum are placed first cicle and at 15, 20, 25, 30, 35, 40 ane 45 s (if at least 6 of the 8 is placed on the same side). Interview: actual and retrospective chewing function (Diernberger et al., 2008): Do (and did) you prefer one side for chewing?; answers: No—yes, the left side—yes, the right side—I do not know. <em><strong>Improvement in the psychological distress</strong></em> using the Symptoms Check List -90- Revised, and the risk of changing the habitual chewing side. Data collection periods: baseline, 3 months and 6 months (primary time for all variables) after therapy. Parasagittal plane <strong>condylar path</strong> tracings were recorded using a kinematic Gerber’s face-bow (Kit Registier Ausrustung ‘C;’ Condylator service, Zurich, Switzerland). Frontal plane <strong>lateral guidance</strong> recordings were conducted using a jaw-tracking device (K7 electrodiagnostic system; Myotronics Inc., Kent, WA, US).
description: Table 1. Sociobiological
 Characteristics.xlsx Data Table 1. Sociobiologic
 characteristics of the randomly selected 77 patients suffering from
 chronic (over 6-months) TMD with substantial self-reported pain referred
 to the tertiary care hospital. The table include main biological and
 demographic characteristics, and blind (1:1) allocation to groups of
 participants in the MAP trial: group, age, gender, ethnicity, handedness
 preference, (previous) orthodontic therapy, the affected side, condition
 (arthralgia vs myalgia), symptoms chronicity, magnetic resonance image
 findings, level of education, marital status, housing tenure, and
 employment status. Table 2. Pain-intensity
 outcome.xlsx Data
 Table 2. Table 2 include data related to the main outcome: reduction in
 the mean intensity of jaw pain from baseline at the 6-month assessment.
 The Excel file includes raw values of pain-intensity at baseline, at the
 3- and 6-months follow-up (6 months are double: per protocol and ITT
 approaches). Pain-intensity was assessed using indistinctly visual
 (Huskisson, 1974) or numerical pain rating scale of 0 to 10 (where 0=no
 pain and 10=worst possible pain), as no differences in results were seeing
 among both scales (Dworkin et al., 2010), and participants chose the more
 understandable one. Clinical important differences 1.5 points.
 Table 3. Maximum unassisted
 mouth opening (mm).xlsx Data Table 3. The maximum
 unassisted mouth opening (mm), the range of interincisal distance, was
 recorded by independent experienced researchers (the 6-months assessment
 was always carried out by the same blind researcher) using a Boley gauge.
 Normal opening range &gt;40 mm. Smallest detectable differences: 3 mm.
 Raw data from all participants are displayed at the three time points:
 baseline, and 3- and 6-months. Table 4. Habitual chewing
 side.xlsx Data
 Table 4. Table 4 shows the side used to chew. Outcome at 6-months is
 biased because of the information gathered to participants at the
 beginning of the study. It will be reported descriptively. Table 5. Habitual chewing
 side.xlsx Data
 Table 5. This table shows the raw values of psychological symptoms and
 distress of participants using the self-administered SCL-90-R, conducted
 by a trialist. It include subscales: somatization, obsessive–compulsive,
 interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety,
 paranoid ideation, and psychoticism; and main combinations, global
 severity index, and positive symptom distress index. Higher scores denote
 higher distress. (Derogatis et al., 1976) Table 6. Pain
 severity.xlsx Data Table 6. Table 6 include raw
 values of pain intensity items, right now, how intense was the worst pain
 during the past 6 months, and on the average (Von Korff et al., 1992).
 Disability items are displayed in Table 9. Time points: baseline and six
 months. Table 7.
 Headache intensity.xlsx Data Table 7. Average headache
 intensity during the past six months was recorded at the three time points
 (baseline, and 3- and 6-months visits). The 0 to 10 visual or numerical
 rating pain scale was used. Table 8. Neuropathic
 symptoms.xlsx Data Table 8. Neuropathic
 symptoms were assessed by using the DN4 questionnaire (Bouhassira
 et al., 2004). It includes self-administered items and also
 clinical assessment. Two time points: baseline and 6-months.
 Table 9.
 Disability.xlsx Data Table 9. Table 9 shows data
 from the questionnaire for disability items or “how much has facial pain
 interfered with your activities” rated on a 0-10 scales was carried (Von
 Korff et al., 1992). Table 10. Perceived effect
 (improvement).xlsx Data Table 10. The subjective
 perception of improvement or worsening was assessed at the 3- and 6-months
 visits, using a numerical scale (3: very much better; 2: much better; 1:
 minimally improved; 0: no change; -1: minimally worse; -2: much worse; -3:
 very much worse). Time points: 3- and 6-months after therapy.
 Table 11.
 Credibility.xlsx Data Table 11. Credibility in the
 procedure scores was assessed on a 0-10 numerical rating scale, with 0=not
 at all, 10= totally (Borkovec and Nau, 1972). Table 12. Awareness of
 trial-group assignment.xlsx Data Table 12. The awareness of
 the trial-group assignment was assessed for participants and assessors.
 The question was: What kind of treatment have you received? real, placebo,
 I do not know. Table 13. Condylar path
 angles.xlsx Data
 Table 13. Table 13 shows parasagittal plane angles (unit: degrees; from
 two independent assessor’s measurements) between condylar path angles and
 the Frankfort line. Time point: at baseline. Table 14. Lateral guidance
 angles.xlsx Data Table 14. Table 13 shows the angles
 (unit: degrees; from 2 independent assessor’s measurements) between dental
 guidance during lateral movements and the Frankfort line in the frontal
 plane. Time points: at baseline and after therapy.