drugset / Trial / NCT07586072
Non-Randomized Trial of Bruxism-Related TMD Treatments
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study compares three treatment approaches for adults with bruxism-related temporomandibular disorder symptoms: occlusal splint therapy, botulinum toxin type A injection, and combined medical-splint therapy. Participants were assigned to one of three non-randomized treatment arms according to clinical indication, symptom profile, shared decision-making, and patient preference. Symptom severity was assessed before treatment and after 3 months using the Fonseca Anamnestic Index. The primary purpose of the study was to compare the 3-month change in total Fonseca Anamnestic Index scores among the treatment arms. Selected symptom items and treatment-related adverse events were also evaluated during follow-up.
Timeline
- Start
- 2024-08-05
- Primary completion
- 2025-08-01
- Completion
- 2025-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 160 iu | Intramuscular |
| Subject | Tenoxicam | Other / unclassified | 20 mg | — |
| Subject | Thiocolchicoside | Small molecule | 8 mg | — |