Long-term efficacy of resilient appliance therapy in TMD pain patients: a randomised, controlled trial

Abstract

The aim was to investigate long-term efficacy of a resilient appliance in patients with pain due to temporomandibular disorders (TMD). A randomised, controlled trial was performed in 80 recruited TMD pain patients. They were randomly allocated to one of two groups: treatment with a resilient appliance or treatment with a hard, palatal, non-occluding appliance. The primary treatment outcome was judged positive when patients' characteristic pain intensity decreased by at least 30%. Additional treatment outcomes were physical functioning, emotional functioning and headache. At the 12-month follow-up 50% of the patients in the treatment group and 42% in the control group had a 30% reduction of characteristic pain intensity, when calculated in an intent-to-treat analysis. Jaw function improved in both groups at the 6- and 12-month follow-up. Emotional functioning improved in both groups at the 6-month follow-up; an improvement concerning grade of depression was found in the control group at 12 months. Headache decreased in both groups at both follow-ups. There were no statistically significant differences found regarding primary and additional outcomes between groups at the 6- and 12-months follow-up. There was no statistically significant difference between the resilient appliance and the non-occluding control appliance in reducing TMD pain, physical functioning, emotional functioning and headache in a 12 months perspective.

External validity and psychiatric disorder exclusions in orofacial pain clinical trials

“…How do we reconcile Figure 2a of Nilsson et al. ’s (1) finding that approximately one‐third of patients in both treatment conditions had symptoms consistent with severe depression at baseline (according to the RDC‐Axis II‐recommended SCL‐90) with the statement that eligibility criteria explicitly excluded patients with even a history of psychiatric disorder? According to their own exclusion rule, perhaps one‐third of enroled patients should have been deemed ineligible as a result of current depression alone.…”

“…In this issue, Nilsson et al. ’s (1) RCCT on resilient appliance therapy concludes that resilient appliances have poor long‐term efficacy in adult patients with temporomandibular (TMD) pain. The strength of the evidence, from an internal validity perspective, is clearly superior to one based solely on clinical experience (2, 3) or weaker research designs.…”

“…A troubling aspect of Nilsson et al. ’s (1) study is that 532 patients were assessed for eligibility, and 452 were excluded for not meeting study selection criteria. This represents a startling low eligibility rate of only 15%.…”

“…IMMPACT’s statement of extended research design considerations (8) notes that, similar to the design choice of Nilsson et al. , (1) many chronic pain trials exclude patients with medical and psychiatric comorbidities.…”

“…A limitation in many TMD‐related studies (9) appears to have occurred in Nilsson et al. ’s (1) RCCT: Much greater sophistication and effort were expended in assessing TMDs than in assessing history of psychiatric disorder or, apparently, any of the exclusion criteria. Assessment of psychiatric disorder is not an easy matter.…”