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

NCT ID: NCT03827122

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-13
• Study Completion Date: 2019-11-13

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.

Conditions

Nocturnal Bruxism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group one

Botx will be injection in masster muscles 20unit Botx (onabotulinumtoxinA) and visual pain scale will be taken before and after in four intervals 2,8,16,48 weeks

Group Type: EXPERIMENTAL

onabotulinumtoxinA

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Botox Allergan

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Baraa Abdulrahman

Master Resident in Oral Diagnostics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baraa abdulrahman, BDS

Role: PRINCIPAL_INVESTIGATOR

Riyadh Colleges of Dentistry and Pharmacy

Locations

Riyadh Elm University

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Baraa abdulrahman, BDS

Role: CONTACT

Baraa.abdulrahman@riyadh.edu.sa

+966582766220

Facility Contacts

Baraa abdulrahman

Role: primary

Other Identifiers

RC/IRB/2018/1247

Identifier Type: -

Identifier Source: org_study_id