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

NCT03827122 | Unknown Phase 2 FDA Drug

• 1 other identifier: RC/IRB/2018/1247
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturnal Bruxism

Keywords

Bruxism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Group one

EXPERIMENTAL

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

Drug: onabotulinumtoxinA

Interventions

onabotulinumtoxinA 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.

Also known as: Botox Allergan

Group one

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• pain in the orofacial region,
• insomnia,
• known botulinum toxin allergy,
• pregnancy,
• neuromuscular disease,
• bleeding disorders,
• antibiotic therapy,
• pulmonary disease that produced coughing during sleep,
• infectious skin lesion at the site of the injection.

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh Elm University

Riyadh, 11681, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Sleep Bruxism; Bruxism

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Habits; Behavior

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Baraa abdulrahman, BDS

  Riyadh Colleges of Dentistry and Pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baraa abdulrahman, BDS

CONTACT

+966582766220; Baraa.abdulrahman@riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Resident in Oral Diagnostics

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

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: February 1, 2019
• Study Start: November 13, 2018
• Primary Completion: November 11, 2019
• Study Completion: November 13, 2019
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)