Efficacy of Centella asiatica on mitigating temporomandibular pain and improving functionality: a randomized, double blind, pilot clinical trial.

Objective: To determine the efficacy of Centella asiatica extract, ECa233, on alleviating pain symptoms and functional improvement of acute temporomandibular disorders (TMD).

Materials and methods: A randomized, double-blind, placebo-controlled, pilot clinical trial was performed using 23 adults with acute TMD. They were randomly assigned into four treatment groups, an ibuprofen (positive control) group, two test groups of ECa233 each of 250 mg, and 500 mg extracts, and a placebo (negative control) group. All subjects were requested to self-administer the test/control capsules, twice a day for 14 days. The pain intensity score, range of mandibular motion and tenderness of the masticatory muscles and temporomandibular joint (TMJ) were recorded at baseline, 7- and 14-days post-treatment.

Results: One week after intervention, the pain intensity score significantly decreased in participants receiving 500 mg of ECa233 (P = 0.016), as well as the placebo group (P = 0.030) but not in the other groups. Additionally, those receiving 500 mg of ECa233 displayed the highest percentage reduction in self-reported pain intensity and pain on TMJ palpation compared with the other groups (P > 0.050). On day 14, there were no significant differences observed among the evaluated parameters in the four groups.

Conclusions: The orally administered ECa233 has the potential to induce rapid, short term, dose-dependent analgesia in individuals with TMD pain. However, longer-term RCT with a larger cohort is necessary to confirm these findings.

Clinical relevance: ECa 233 at 500 mg has the potential to induce a more rapid analgesic response in individuals with acute TMD after a 7-day period.

Trial registration: This trial was registered on the ClinicalTrials.gov, the number is NCT06231212, date of registration: 30/01/2024.