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.
This is a prospective, non-randomized, open-label, controlled, parallel-arm clinical trial evaluating treatment outcomes in patients with bruxism-related temporomandibular disorder symptoms. A total of 60 adult participants were assigned to one of three treatment arms: occlusal splint therapy, botulinum toxin type A injection, or combined medical-splint therapy. Participants in the occlusal splint arm received custom-made maxillary stabilization splints and were instructed to use the splints during sleep. Participants in the botulinum toxin type A arm received a single session of intramuscular injections into the masseter and temporalis muscles. Participants in the combined medical-splint arm received a maxillary stabilization splint together with a short-term pharmacological regimen for acute symptom control. The Fonseca Anamnestic Index was administered at baseline and at the 3-month follow-up. The primary outcome was the change in total Fonseca Anamnestic Index score from baseline to 3 months. Secondary assessments included changes in selected Fonseca Anamnestic Index sub-item scores, changes in Fonseca Anamnestic Index severity categories, and monitoring of treatment-related adverse events. Because of the nature of the interventions, participants and clinicians were not blinded to treatment assignment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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 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 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 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.
Recep Tayyip Erdogan University Faculty of Dentistry
Rize, Rize Province, Turkey (Türkiye)
Change in Total Fonseca Anamnestic Index Score
Change in total Fonseca Anamnestic Index score from baseline to the 3-month follow-up. The change score was calculated as pre-treatment total score minus post-treatment total score. Higher positive values indicate greater symptom improvement.
Time frame: Baseline to 3 months
Change in Selected Fonseca Anamnestic Index Sub-Item Scores
Changes in selected Fonseca Anamnestic Index sub-item scores from baseline to the 3-month follow-up. The selected items assessed mouth opening difficulty, masticatory muscle fatigue or pain during chewing, temporomandibular joint clicking, and teeth clenching or grinding habit.
Time frame: Baseline to 3 months
Change in Fonseca Anamnestic Index Severity Category
Change in categorical Fonseca Anamnestic Index severity classification from baseline to the 3-month follow-up. Total scores were categorized as absence of TMD-related symptoms, mild symptoms, moderate symptoms, or severe symptoms according to the Fonseca Anamnestic Index classification.
Time frame: Baseline to 3 months
Treatment-Related Adverse Events
Occurrence of treatment-related adverse events during the 3-month follow-up period, including injection-site symptoms, chewing weakness, facial asymmetry, dysphagia, medication-related intolerance, splint-related discomfort, mucosal irritation, or occlusal changes. Serious adverse events were defined as events requiring urgent medical care, hospitalization, treatment discontinuation, or resulting in persistent functional impairment.
Time frame: Up to 3 months
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