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Comparing injecting botulinum toxin type A in the masseter muscle only to the additional injection in the lateral pterygoid muscle in patients with bruxism

Comparative effectiveness of injecting botulinum toxin type A in the masseter muscle only to the additional injection in the lateral pterygoid muscle in patients with bruxism: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13377883
Enrollment
30
Registered
2024-12-20
Start date
2024-01-03
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism Oral Health

Interventions

Clinical examination, documentation of participant’s demographic characteristics, and medical history were performed before enrollment. Individuals referred to the Department of Oral and Maxillofacial

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients whose bruxism score was =50% according to the Kanathila et al. questionnaire 2. Patients aged 18-40 years 3. Increase in the masseter and lateral pterygoid muscle activity 4. Clinical sign of dental erosion

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women 2. Patients receiving therapy such as occlusal splints or previous injections of BTX/A 3. Allergy to BTX/A 4. Severe malocclusion 5. Patients who were undergoing orthodontic treatment 6. Infection at the injection site

Design outcomes

Primary

MeasureTime frame
1. Electromyography of the muscles was measured using an electromyography device (2-channel electromyograph MYOQUICK®, Micromed®, Rome, Italy) before treatment (t0) and 2 weeks after treatment (t1). Regarding the masseter muscle, custom gel (EEG Paste, AQUA Medical, Istanbul, Turkey) was placed on the surface electrodes, with an interval of approximately 3 cm between them, parallel to the fibers of the masseter muscle, in the middle of the muscle, and fixed for accurate measurement. While the ground electrode was placed in the middle of the forehead, its purpose was to distort and remove noise. The patient bit hard on their teeth to clench in the central occlusal position. The measurement was conducted to obtain three values, the highest and the lowest, and the difference was estimated in (µv). Regarding electromyography of the lateral pterygoid muscle, the first surface electrode was placed in front of the ear, the ground electrode was placed in the middle of the forehead, and the EMG Needle was used as a deep electrode for electromyography first, followed by measurement and injection. 2. Bruxism: the participants were asked whether they clenched their teeth during the day or while sleeping and if anyone noticed that they clenched. They were also asked if they had a stiff jaw or facial spasm when they woke up. The questionnaire has four close-ended questions. The scoring was (0) for each no answer and (1) for each yes answer, then presented as a percentage. Patients' answers to the questionnaire were recorded five times before treatment (t0), 2 weeks after treatment (t1), 6 weeks after treatment (t2), 3 months after treatment (t3), and 6 months after treatment (t4).

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

Syria

Contacts

Public ContactMawia Karkoutly
mawia95.karkoutly@damascusuniversity.edu.sy+963 (0)992 647 528

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026