Clinical Research Directory
Browse clinical research sites, groups, and studies.
Botulinum Toxin Type A Versus Oral Ibuprofen for Bruxism
Sponsor: NEW Cyprus Health and Social Sciences University
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.
Official title: The Effect of Botulinum Toxin Type A on Quality of Life During Bruxism Treatment: A Randomized Controlled Trial Comparing Botulinum Toxin Type A With Oral Ibuprofen in Patients With Jaw Muscle Pain
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-02-06
Completion Date
2026-06-26
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Interventions
Botulinum Toxin Type A 100U
Botulinum Toxin Type A was administered by intramuscular injection into the bilateral masseter and temporalis muscles according to the study protocol. The intervention was performed once at baseline, and participants were followed for 20 weeks to evaluate pain intensity, oral health-related quality of life, muscle tenderness, and mandibular function.
Ibuprofen
Ibuprofen was administered orally at a dose of 600 mg three times daily for one week according to the study protocol. Participants were followed for 20 weeks to evaluate pain intensity, oral health-related quality of life, muscle tenderness, and mandibular function.
Locations (1)
New Cyprus Health and Social Sciences University
Güzelyurt (Morphou), Northern Cyprus, Cyprus