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

Nocturnal Bruxism Clinical Trial

Official title:

Botulinum Toxin A Injectable Solution in the Management of Bruxism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827122
• Other study ID #: RC/IRB/2018/1247
• Status: Recruiting
• Phase: Phase 2
• Start date: November 13, 2018
• Est. completion date: November 13, 2019

Study information

• Verified date: January 2019
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: Baraa abdulrahman, BDS
• Phone: +966582766220
• Email: Baraa.abdulrahman[@]riyadh.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 13, 2019
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bruxism
• Nocturnal Bruxism
• Sleep Bruxism

Intervention

Drug:
• onabotulinumtoxinA
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.

Locations

Country	Name	City	State
Saudi Arabia	Riyadh Elm University	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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