Abstract

Background: Idiopathic peripheral facial paralysis often leads to chronic facial motor deficits in 30% of patients, significantly impacting their quality of life. Current treatment options for the chronic phase are limited. Polydioxanone (PDO) thread embedding has shown promise in improving facial disability in these patients, but evidence is scarce.

Objective: This pilot study aimed to explore the feasibility, preliminary safety, and potential effects of PDO thread embedding on improving facial motor function and disability in patients with chronic idiopathic peripheral facial paralysis.

Methods: In this prospective, single-arm, open-label clinical trial, 33 patients with chronic idiopathic peripheral facial paralysis (≥3 months) and Facial Disability Index (FDI) scores indicating significant impairment completed the study. Patients received weekly PDO thread embedding sessions for 6 weeks, with 10 threads per session. The primary outcome was the change in total FDI scores after 6 weeks. Secondary outcomes included changes in House-Brackmann grading (HB Grade), the proportion of patients achieving clinical improvement, and adverse events.
Results: The intervention was associated with a significant improvement in the mean total FDI score, which increased from 88.30 ± 22.05 at baseline to 155.45 ± 18.39 at endpoint (p < 0.001). Both physical and social-well-being sub-scores improved significantly. Additionally, the proportion of patients classified as House-Brackmann Grade III (moderate) or better increased from 30.3% at baseline to 81.8% at endpoint (p < 0.001). Adverse events were mild and transient.
Conclusion: This pilot study suggests that PDO thread implantation is a feasible and generally safe intervention, demonstrating promising preliminary evidence for improving facial motor function and overall quality of life in patients with chronic peripheral facial paralysis. The results warrant confirmation through larger-scale, randomized controlled trials.