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Completed
NCT07586072
Short-Term Symptom Changes in Adults With Teeth Clenching or Grinding and Jaw Symptoms Receiving Splint, Botulinum Toxin, or Medication Plus Splint Care
Conditions: Bruxism, Temporomandibular Disorders (TMD), Myofascial Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 60
Sponsor: Recep Tayyip Erdogan University
Location: Recep Tayyip Erdogan University Faculty of Dentistry Rize Rize Province
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07586072). StuddyBuddy aggregates publicly available trial information.