Bruxism, Temporomandibular Disorders (TMD), Myofascial Pain
Conditions
Keywords
Occlusal splint, Botulinum toxin type A, Medical-splint therapy, Fonseca Anamnestic Index, Masticatory muscle pain, Bruxism-related TMD symptoms, Temporomandibular disorder symptoms
Brief 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.
Detailed description
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.
Interventions
DEVICEOcclusal 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 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.
DRUGThiocolchicoside
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.
DRUGtenoxicam
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.
Sponsors
Recep Tayyip Erdogan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking was performed because of the nature of the interventions. Participants and care providers were aware of the assigned treatment.
Intervention model description
Participants were assigned to one of three parallel active treatment arms: occlusal splint therapy, botulinum toxin type A injection, or combined medical-splint therapy. Treatment assignment was non-randomized and open-label.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older. * Presence of bruxism-related temporomandibular disorder symptoms. * Self-reported sleep or awake bruxism based on clenching or grinding awareness. * Clinical signs compatible with bruxism, including dental attrition, cupped-out wear facets, or shiny occlusal surfaces. * Absence of known systemic conditions that could interfere with treatment or outcome assessment. * Ability to provide written informed consent.
Exclusion criteria
* Age younger than 18 years. * Presence of systemic or neurological disorders. * Uncontrolled psychiatric conditions. * Infection or inflammatory lesions at the planned injection sites. * History of maxillofacial surgery or severe trauma in the relevant orofacial region. * Inability or unwillingness to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Fonseca Anamnestic Index Score | Baseline to 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Selected Fonseca Anamnestic Index Sub-Item Scores | Baseline to 3 months | 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. |
| Change in Fonseca Anamnestic Index Severity Category | Baseline to 3 months | 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. |
| Treatment-Related Adverse Events | Up to 3 months | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORSedef KURT CIRALIK
Recep Tayyip Erdogan University, Faculty of Dentistry
Outcome results
None listed