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Short-Term Symptom Changes in Adults With Teeth Clenching or Grinding and Jaw Symptoms Receiving Splint, Botulinum Toxin, or Medication Plus Splint Care
Sponsor: Recep Tayyip Erdogan University
Summary
This prospective observational study evaluated short-term patient-reported symptom changes in adults with bruxism-related and temporomandibular disorder symptoms who received one of three clinically selected management approaches: occlusal splint therapy, botulinum toxin type A injection, or short-term pharmacotherapy combined with splint therapy. Management selection reflected routine clinical decision-making based on clinical indication, symptom profile, shared decision-making, and patient preference and was not determined by random allocation. Symptom severity was assessed at baseline and after 3 months using the Fonseca Anamnestic Index. The primary objective was to describe the 3-month change in total Fonseca Anamnestic Index scores within the clinically selected cohorts and to explore whether longitudinal change patterns differed among them. Selected Fonseca Anamnestic Index items, severity-category changes, and clinically recorded treatment-related adverse events were also evaluated as secondary outcomes.
Official title: Short-Term Patient-Reported Symptom Changes Across Clinically Selected Management Pathways in Adults With Bruxism-Related and Temporomandibular Disorder Symptoms: A Prospective Non-Randomized Observational Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2024-08-05
Completion Date
2025-08-01
Last Updated
2026-07-30
Healthy Volunteers
No
Interventions
Occlusal splint
Custom-made maxillary stabilization splints were fabricated from hard acrylic resin and adjusted to obtain simultaneous bilateral posterior contacts in centric relation and canine guidance during eccentric movements. Participants were instructed to wear the splints during sleep for at least eight hours per night.
Botulinum Toxin Type A (Dysport®)
Botulinum toxin type A was administered as a single intramuscular injection session. Dysport was reconstituted with 2 mL sterile 0.9% saline. A total dose of 160 U Dysport was administered per participant, consisting of 60 U into each masseter muscle and 20 U into each temporalis muscle.
Thiocolchicoside
Thiocolchicoside 8 mg/day was prescribed as part of a short-term pharmacological regimen for acute symptom control in the combined medical-splint therapy arm. The medication was used for 7 to 10 days.
tenoxicam
Tenoxicam 20 mg/day was prescribed as part of a short-term pharmacological regimen for acute symptom control in the combined medical-splint therapy arm. The medication was used for 7 to 10 days.
Locations (1)
Recep Tayyip Erdogan University Faculty of Dentistry
Rize, Rize Province, Turkey (Türkiye)