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MAP trial: Occlusal adjustment vs placebo for chronic temporomandibular disorders: Raw data

Citation

Santana-Penin, Urbano et al. (2022), MAP trial: Occlusal adjustment vs placebo for chronic temporomandibular disorders: Raw data, Dryad, Dataset, https://doi.org/10.5061/dryad.zkh189370

Abstract

This randomized clinical trial assessed the effect of occlusal adjustment vs placebo in 77 randomized adult patients suffering from moderate to severe (≥4 and ≤9 scores on a 0–10 visual analogue scale) chronic (over six months) facial pain diagnosed as temporomandibular joint (TMJ) disorder (TMD). The fully dentate patients had normal occlusion and had previously received typical conservative or minimally invasive therapies. The main outcome was change in the mean intensity of jaw pain from baseline at the 6-month assessment. Secondary variables were an increase in maximum unassisted mouth opening (smallest detectable difference 3 mm), improvement in the mental component using the Symptoms Check List -90- Revised, and the risk of changing the habitual chewing side. Other prespecified variables were pain severity, headache intensity, neuropathic symptoms, disability, perceived improvement, credibility, and awareness of trial-group assignment. Diagnostic variables were condylar path and lateral guidance angles and sociodemography.

Data Collection emerged from the development of a new TMD paradigm where the affected side could be the habitual chewing side, the side with flatter lateral jaw motion or the side with an increased CP angle. These data may lead to improved diagnosis, therapy plans, and therapy in patients with TMD. Data should be analyzed according to Intention-To-Treat (ITT) principle.

Trial registration: Universal Trial Number (UTN): U1111-1134-0832; ClinicalTrials.gov Identifier: NCT02144233; International Standard Randomized Controlled Trial Number ISRCTN61654487 - http://www.controlled-trials.com/ISRCTN61654487/.

Methods

Pain-intensity 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.

Maximum unassisted jaw opening, using a Boley gauge (including overbite) units mm. Defined as limited if ≤38 mm (females) or ≤40 mm (males)

Chewing function (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.

Improvement in the psychological distress 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 condylar path tracings were recorded using a kinematic Gerber’s face-bow (Kit Registier Ausrustung ‘C;’ Condylator service, Zurich, Switzerland).

Frontal plane lateral guidance recordings were conducted using a jaw-tracking device (K7 electrodiagnostic system; Myotronics Inc., Kent, WA, US).

Usage Notes

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 >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.

Funding

Instituto de Salud Carlos III, Award: PI11/02507