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

Riyadh Colleges of Dentistry and Pharmacy

Status and phase: Unknown; Phase 2

Conditions: Nocturnal Bruxism

Treatments: Drug: onabotulinumtoxinA

Study type: Interventional

Funder types: Other

Identifiers

NCT03827122

RC/IRB/2018/1247

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Group one

Experimental group

Description:

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

Treatment:

Drug: onabotulinumtoxinA