Pain, FacePhase 4NCT03456154
Botox vs Occlusal Splint for Masseter Pain
A Phase 4 study testing Botox Injectable Product and Occlusal splint in people with Pain, Face, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
This randomized clinical trial will compare the standard treatment (occlusal splint) and botox for the treatment of face muscular pain in adults. Fifty patients will be invited and selected, and allocated to the experimental group, according to the randomization sequence previously performed. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Face
- What is being tested?
- Botox Injectable Product and Occlusal splint
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Mar 2018to 1 Mar 2021
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18 and 70 years old;
- at least 20 teeth in the mouth;
- occlusal stability;
- presenting pain in face muscles.
Who cannot join
- Angle's Class III
- Kennedy's Class II or I removable partial denture wearer;
- Complete denture wearer;
- Individuals that have taken any anti inflammatory drugs in the last 3 months;
- Individuals with temporomandibular joint disorders.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015560
About this study
Official title: Use of Botox Versus Conventional Treatment for Pain Decrease of Muscular Pain: a Randomized Controlled Trial
This randomized clinical trial will compare the standard treatment (occlusal splint) and botox for the treatment of face muscular pain in adults. Fifty patients will be invited and selected, and allocated to the experimental group, according to the randomization sequence previously performed. For the splint group, a rigid splint will be worn by the patient every night. For the botox group, 60u of botox will be injected in 3 regions of the masseter muscle. Patients will be assessed before the experiment, 3 and 6 months after the beginning of the study. Oral health related quality of life, pain, and cervical neck position will be evaluated. Paired t-test and chi-square will be used for statistical analysis.
- Conditions
- Pain, Face
- Being tested
- Botox Injectable Product, Occlusal splint
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox Injectable ProductDrug
60u will be used at 3 sites of masseter muscle, on each side of the face
Occlusal splintDevice
In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.
| Study group | Role | What they receive |
|---|---|---|
| Botox | Experimental | In this group patients will receive 3 injections of botox on each masseter (left and right), after randomization. This injection will be performed once, and the patient will be evaluated after 3 and 6 months after this day. Receives: Drug: Botox Injectable Product |
| Occlusal splint | Active comparator | In this group patients will receive an occlusal splint, which will be manufactured after taking their full mouth impression. This appliance has to be worn everyday, for 6 months, at night. Receives: Device: Occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory muscle pain
VAS will be used to assess decrease of pain
Measured: baseline, 3 and 6 months
Secondary outcomes (2)
Oral health related quality of life
OHIP 14 questionnaire will be applied
Measured: baseline, 3 and 6 months
Cervical Position
Modifications of cervical vertebral column position will be assessed
Measured: baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start15 Mar 2018
- Primary completion15 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, FaceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456154
- Sponsor's protocol ID
- PPGO022
- Status last verified
- May 2021
- First submitted
- 28 Feb 2018
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pires ALC, Galdino Santos L, Poletto-Neto V, Luz MS, Damian MF, Pereira-Cenci T. Evaluation of craniocervical posture after myofascial pain treatment in adults with bruxism: A randomized clinical trial. J Bodyw Mov Ther. 2024 Oct;40:1795-1801. doi: 10.1016/j.jbmt.2024.10.032. Epub 2024 Oct 16.
PubMed 39593526Chisini LA, Pires ALC, Poletto-Neto V, Damian MF, Luz MS, Loomans B, Pereira-Cenci T. Occlusal splint or botulinum toxin-a for jaw muscle pain treatment in probable sleep bruxism: A randomized controlled trial. J Dent. 2024 Dec;151:105439. doi: 10.1016/j.jdent.2024.105439. Epub 2024 Nov 5.
PubMed 39510242
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Botox Versus Conventional Treatment for Pain Decrease of Muscular Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03456154
- Acronym / sponsor ID
- PPGO022
- Conditions
- Pain, Face
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 7 Mar 2018 (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.
This randomized clinical trial will compare the standard treatment (occlusal splint) and botox for the treatment of face muscular pain in adults. Fifty patients will be invited and selected, and allocated to the experimental group, according to the randomization sequence previously performed. For the splint group, a rigid splint will be worn by the patient every night. For the botox group, 60u of botox will be injected in 3 regions of the masseter muscle. Patients will be assessed before the experiment, 3 and 6 months after the beginning of the study. Oral health related quality of life, pain, and cervical neck position will be evaluated. Paired t-test and chi-square will be used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox | Experimental | Drug: Botox Injectable ProductIn this group patients will receive 3 injections of botox on each masseter (left and right), after randomization. This injection will be performed once, and the patient will be evaluated after 3 and 6 months after this day. |
| Occlusal splint | Active comparator | Device: Occlusal splintIn this group patients will receive an occlusal splint, which will be manufactured after taking their full mouth impression. This appliance has to be worn everyday, for 6 months, at night. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18 and 70 years old;
- at least 20 teeth in the mouth;
- occlusal stability;
- presenting pain in face muscles.
Key exclusion criteria (5 listed)
- Angle's Class III
- Kennedy's Class II or I removable partial denture wearer;
- Complete denture wearer;
- Individuals that have taken any anti inflammatory drugs in the last 3 months;
- Individuals with temporomandibular joint disorders.
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 |
|---|---|---|
| Botox Injectable Product60u will be used at 3 sites of masseter muscle, on each side of the face | Drug | Botox |
| Occlusal splintIn this group patients will receive an occlusal splint which will be worn everyday for 6 months at night. | Device | Occlusal splint |
Primary outcome
Masticatory muscle pain
Time frame: baseline, 3 and 6 months
VAS will be used to assess decrease of pain
2 secondary outcomes
Oral health related quality of life
Time frame: baseline, 3 and 6 months
Cervical Position
Time frame: baseline, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Derived from this study: PubMed 39593526Pires ALC, Galdino Santos L, Poletto-Neto V, Luz MS, Damian MF, Pereira-Cenci T. Evaluation of craniocervical posture after myofascial pain treatment in adults with bruxism: A randomized clinical trial. J Bodyw Mov Ther. 2024 Oct;40:1795-1801. doi: 10.1016/j.jbmt.2024.10.032. Epub 2024 Oct 16.
- Derived from this study: PubMed 39510242Chisini LA, Pires ALC, Poletto-Neto V, Damian MF, Luz MS, Loomans B, Pereira-Cenci T. Occlusal splint or botulinum toxin-a for jaw muscle pain treatment in probable sleep bruxism: A randomized controlled trial. J Dent. 2024 Dec;151:105439. doi: 10.1016/j.jdent.2024.105439. Epub 2024 Nov 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botox Injectable Product and Occlusal splint in people with Pain, Face, run by Federal University of Pelotas at 1 site in Brazil.
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 5 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: finished, as of the sponsor's last update on 20 May 2021. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masticatory muscle pain (time frame: baseline, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03456154, which also lists 2 linked publications.
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 20 May 2021.