The Use of Low-Dose Botulinum Toxin Injection Into the Masseter Muscle to Treat Sleep Bruxism

• Status: Completed
• Trial end date: 2022-02-10
• Target enrollment: 0
• Participant gender: All

Summary

Botulinum toxin (BOTOX®) injections into the masseter muscle are an effective treatment for nocturnal bruxism, with several trials using various dosages of botulinum toxin for this purpose. The aim was to evaluate the effectiveness of injecting 10MU of botulinum toxin A (BTXA) into the masseter muscle to reduce nocturnal bruxism, the sample will randomly divided into 2 groups.

In the injection group, Patients will inject with 10 MU of botulinum toxin type A (BOTOX® - Allergan Inc. - Dublin - Ireland) per side at two sites into the masseter muscle bilaterally.

In this Placebo group, patients will prick twice at the inferior prominent part of the masseter muscle observed using the stinger pen used in the blood glucose meter.

The evaluation will make by Electromyography (EMG) analysis, Visual Analogue Scale (VAS) values.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Damascus University

Criteria

Inclusion Criteria:

1. Moderate to severe pain in the masseter muscles during clinical examination.

2. Age range between 18 and 40 years.

3. Tooth-grinding sounds corroborated by family members or caregivers.

4. Attrition in occlusal surface of posterior teeth.

Exclusion Criteria:

1. Loss two posterior teeth or more (except for third molars).

2. Fixed or movable prosthodontics for more than four dental units.

3. Advanced malocclusion (Class II occlusion Model II - deep bite - open bite).

4. Temporomandibular disorders.

5. Pain in the orofacial region.

6. Insomnia.

7. Known botulinum toxin allergy.

8. Pregnancy.

9. Neuromuscular disease.

10. Bleeding disorders.

11. Antibiotic therapy, pulmonary disease that produced coughing during sleep.

12. Infectious skin lesion at the site of the injection.