Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07586072). StuddyBuddy aggregates publicly available trial information.