Nocturnal BruxismPhase 2NCT03827122
Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study
A Phase 2 study testing onabotulinumtoxinA in people with Nocturnal Bruxism, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nocturnal Bruxism
- What is being tested?
- onabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 13 Nov 2018to 13 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- pain in the orofacial region,
- insomnia,
- known botulinum toxin allergy,
- pregnancy,
- neuromuscular disease,
- bleeding disorders,
Show all 9Show fewer
- antibiotic therapy,
- pulmonary disease that produced coughing during sleep,
- infectious skin lesion at the site of the injection.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Riyadh Elm University
Riyadh, 11681
Baraa abdulrahman
About this study
Official title: Botulinum Toxin A Injectable Solution in the Management of Bruxism
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.
- Conditions
- Nocturnal Bruxism
- Being tested
- onabotulinumtoxinA
- Keywords
- Bruxism
- Medical subject headings
- Sleep Bruxism, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinADrug
Also called Botox Allergan
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: onabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction after botox injection subjective
Visual pain scale with a score from 0 to 10
Measured: Change in clenching after 2,8,16,48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start13 Nov 2018
- Primary completion11 Nov 2019 (estimated)
- Study completion13 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group with bruxism they will be injected in masster muscles bilaterally
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baraa Abdulrahman, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Baraa abdulrahman, BDS, Principal investigator, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827122
- Sponsor's protocol ID
- RC/IRB/2018/1247
- Status last verified
- Jan 2019
- First submitted
- 11 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin A Injectable Solution in the Management of Bruxism
- ClinicalTrials.gov ID
- NCT03827122
- Acronym / sponsor ID
- RC/IRB/2018/1247
- Conditions
- Nocturnal Bruxism
- Keywords
- Bruxism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 11 Nov 2019 (estimated)
- Study completion
- 13 Nov 2019 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group with bruxism they will be injected in masster muscles bilaterally
| Arm | Type | Receives |
|---|---|---|
| Group one | Experimental | Drug: onabotulinumtoxinABotx 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- pain in the orofacial region,
- insomnia,
- known botulinum toxin allergy,
- pregnancy,
- neuromuscular disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| onabotulinumtoxinAAlso: Botox AllerganExperimental 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. | Drug | Group one |
Primary outcome
Pain reduction after botox injection subjective
Time frame: Change in clenching after 2,8,16,48 weeks
Visual pain scale with a score from 0 to 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Nocturnal Bruxism
RecruitingObservational study
Orofacial Pain and Oral Health-Related Quality of Life in Musicians in German Amateur Orchestras
Orofacial Pain, Sleep Bruxism
Not yet recruitingObservational study
Bruxism Induced by Obstructive Sleep Apnoea.
Sleep Apnea Syndrome, Obstructive, Bruxism, Sleep-Related
Enrolling by invitationObservational study
Relationship Between Selected Parameters and Bruxism
Sleep Bruxism, Sleep Disorder
Active, not recruiting
Effect of Marjoram, Vetiver, and Lavender Oil in the Treatment of Bruxism
Bruxism, Bruxism, Sleep
Recruiting
Bruxism Therapy of Facial Pain
Bruxism, Bruxism, Sleep-Related
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baraa abdulrahman, BDS principal investigator
Riyadh Colleges of Dentistry and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing onabotulinumtoxinA in people with Nocturnal Bruxism, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baraa abdulrahman, BDS (+966582766220, Baraa.abdulrahman@riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction after botox injection subjective (time frame: Change in clenching after 2,8,16,48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.