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Status unknownNCT03827122Updated Feb 1, 2019

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

A Phase 2 interventional study of onabotulinumtoxinA in Nocturnal Bruxism, sponsored by Riyadh Colleges of Dentistry and Pharmacy. Status unknown at 1 site in Saudi Arabia. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-01.

Sponsored by Riyadh Colleges of Dentistry and Pharmacy · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nocturnal Bruxism

Keywords

  • Bruxism
03

In context

Bruxism

166 studies on the registry are indexed under Bruxism; 38 are open to participants now.

This study's planned enrollment of 20 is below the median of 38 across 103 interventional studies indexed under Bruxism.

Browse Bruxism studies →

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy is the lead sponsor of 27 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    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

    Drug: onabotulinumtoxinA

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.

    Also known as: Botox Allergan

06

What researchers measure

Primary outcomes

  1. Pain reduction after botox injection subjective

    Visual pain scale with a score from 0 to 10

    Time frame: Change in clenching after 2,8,16,48 weeks

07

Study locations

1 of 1 sites recruiting
  • Riyadh Elm University
    Riyadh, 11681, Saudi Arabia
    • Baraa abdulrahman · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03827122
Lead sponsor
Riyadh Colleges of Dentistry and Pharmacy
Responsible party
Baraa Abdulrahman (Master Resident in Oral Diagnostics, Riyadh Colleges of Dentistry and Pharmacy) — Principal investigator
First posted
Feb 1, 2019
Start date
Nov 13, 2018
Primary completion
Nov 11, 2019 (estimated)
Completion
Nov 13, 2019 (estimated)
Last update
Feb 1, 2019

Study contacts

Baraa abdulrahman, BDS
Contact
Baraa.abdulrahman@riyadh.edu.sa
+966582766220
Baraa abdulrahman, BDS
principal investigator · Riyadh Colleges of Dentistry and Pharmacy

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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