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.
Inclusion Criteria:
Exclusion Criteria:
Due to the nature of the interventions (Botulinum Toxin Type A injections versus oral ibuprofen therapy), blinding of participants and the treating investigator was not feasible. Outcome assessment was based on standardized patient-reported outcome measures (VAS and OHIP-14), and statistical analyses were performed using coded data to minimize analytical bias.
Participants in this arm received Botulinum Toxin Type A (Otesaly® Botulinum Toxin Type A) was administered under aseptic conditions. A total dose of 100 units was used for each patient. Thirty units were injected into each masseter muscle and distributed across three standardized injection points (10 units per point) located within the prominent belly of the muscle. Twenty units were injected into each temporalis muscle and distributed across two injection points (10 units per point) within the anterior portion of the muscle. The injection sites were identified through clinical palpation while the patient performed maximal clenching to ensure accurate localization of muscle activity. All injections were performed using a standardized technique to ensure consistency among participants and minimize treatment variability.
Participants in this arm received oral ibuprofen with 600 mg administered three times daily for one week.
Güzelyurt (Morphou), Northern Cyprus 99750, Cyprus
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