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Completed NCT07732751

Botulinum Toxin Type A Versus Oral Ibuprofen for Bruxism

Conditions: Bruxism, Myofascial Pain

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 40
Sponsor: NEW Cyprus Health and Social Sciences University

Location: New Cyprus Health and Social Sciences University Güzelyurt (Morphou) Northern Cyprus

Summary

This randomized controlled trial evaluated the effectiveness of Botulinum Toxin Type A compared with oral ibuprofen in reducing pain and improving oral health-related quality of life in patients with sleep bruxism and jaw muscle pain. Forty participants diagnosed with sleep bruxism were randomly assigned to receive either Botulinum Toxin Type A injections into the masseter and temporalis muscles or oral ibuprofen therapy. Participants were followed for 20 weeks. The primary outcome was pain intensity measured using the Visual Analogue Scale (VAS). Secondary outcomes included oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14), muscle tenderness, and mandibular function.

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 years or older. * Clinical diagnosis of sleep bruxism. * Presence of jaw muscle pain. * Ability to provide written informed consent. Exclusion Criteria: * Pregnancy or breastfeeding. * Previous botulinum toxin treatment within 6 months. * Neuromuscular disorders. * Allergy to botulinum toxin or ibuprofen. * Use of medications affecting neuromuscular function.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07732751). StuddyBuddy aggregates publicly available trial information.