Comparison of amitriptyline with stabilization splint and placebo in chronic TMD patients: a pilot study.

OBJECTIVE OF WORK: The authors conducted a clinical study to evaluate the effectiveness of amitriptyline in treatment of chronic TMD patients and to compare treatment results with stabilization splint. MATERIALS AND METHODS: Twenty-one patients with chronic TMD were included and randomly distributed into 3 groups: patients in Group A received amitriptyline, patients in Group B received placebo, and those in Group C were treated with stabilization splint. Treatment outcomes (pain assessed by a visual analogue scale (VAS), maximal comfortable mouth opening (MCO) and oral health related quality of life (OHIP-14)) were taken at baseline (before treatment), and at 1(st), 6(th) and 12(th) week of treatment. RESULTS: No statistically significant differences between the groups at baseline were found (p>0.05). VAS scores improved significantly in Group A (F=11.326, p=0.002, effect size =0.791) and in group C (F=7.343, p=0.005, effect size=0.647). Mean OHIP-14 scores decreased significantly only in Group A (F=4.417, p=0.036, effect size =0.596). In Group B, VAS and OHIP-14 scores did not change significantly over time. Subjects in Group C had a significant change in MCO relative to Group A and Group B. CONCLUSION: From this pilot study it can be concluded that the use of low doses of amitriptyline for a period of 12 weeks is effective for pain management and quality of life improvement in chronic TMD patients. Stabilization splint demonstrated superiority in the management of limited mouth opening during the same period.