Evaluating amitriptyline's role in chronic TMD management: a placebo-controlled trial.

BACKGROUND: To assess the effectiveness of low-dose amitriptyline in reducing pain and improving oral health-related quality of life in individuals with chronic temporomandibular disorders (TMD) over a 2-month period, compared to placebo. METHODS: Forty participants were randomly assigned to receive either 25 mg of amitriptyline or a placebo pill for 2 months. The primary outcome was pain intensity, measured using a visual analogue scale (VAS). The secondary outcome was the impact of pain on oral health-related quality of life, assessed by the Oral Health Impact Profile questionnaire (OHIP-14). Evaluations were conducted at baseline and after the 1st and 2nd months of treatment. RESULTS: No statistically significant differences were observed between the treatment groups at baseline (p > 0.05). After 2 months of treatment participants in amitriptyline group experienced a significantly greater reduction in spontaneous pain, with a 63.3% decrease in VAS scores. Participants in placebo group showed a much smaller reduction in spontaneous pain, with only a 16.2% decrease in VAS scores. Additionally, the amitriptyline group demonstrated a significant improvement in OHIP-14 scores (p < 0.001), whereas the placebo group showed no significant change in oral health-related quality of life (p = 0.184). CONCLUSION: This study highlights low-dose amitriptyline as an effective treatment for chronic TMD, showing significant pain reduction and improved quality of life, underscoring its value in a multimodal approach despite the need for further research to personalize care. TRIAL REGISTRATION: This study was registered retrospectively in ISRCTNregistry under the number ISRCTN17622685, on 01/10/2024.