Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study

Botulinum Toxin A Injectable Solution in the Management of Bruxism

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03827122

Enrollment

Registered

2019-02-01

Start date

2018-11-13

Completion date

2019-11-13

Last updated

2019-02-01

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

Conditions

Nocturnal Bruxism

Keywords

Bruxism

Brief summary

A Clinical Trial Study to investigate the potential performance of BTXA on masseter muscle on patient with nocturnal bruxism and to check the pain scale and share this clinical experience.

Detailed description

Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally participated in this study. The patients age 18-60 years. According to the diagnostic grading system of bruxism all subjects will have an assessment including a bruxism questionnaire (i.e., oral history taking with specific focus on bruxism habits) plus a clinical examination to evaluate bruxism signs and symptoms.

Interventions

DRUGonabotulinumtoxinA

Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally Patients will have treatment with 20 units of BOTOX, (Allergan Inc.) per side will be injected at three points into masseter muscle bilaterally.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single group with bruxism they will be injected in masster muscles bilaterally

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

1. Moderate to severe pain in relation to the masseter muscles and TMJ area related to bruxism during clinical examination. 2. Aged 20-60 patients. 3. Tooth-grinding sounds corroborated by family members or caregivers. 4. Cases where bruxism resulted in occlusal surface attrition of posterior teeth

Exclusion criteria

1. pain in the orofacial region, 2. insomnia, 3. known botulinum toxin allergy, 4. pregnancy, 5. neuromuscular disease, 6. bleeding disorders, 7. antibiotic therapy, 8. pulmonary disease that produced coughing during sleep, 9. infectious skin lesion at the site of the injection.

Design outcomes

Primary

Measure	Time frame	Description
Pain reduction after botox injection subjective	Change in clenching after 2,8,16,48 weeks	Visual pain scale with a score from 0 to 10

Countries

Saudi Arabia

Contacts

Primary ContactBaraa abdulrahman, BDS

Baraa.abdulrahman@riyadh.edu.sa+966582766220

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026