Myofascial Pain SyndromeBTXNCT06258070
Clinical Performance of Therapeutic Use of BTX for Bruxism
A study testing Abobotulinumtoxin A injection for bruxism in people with Myofascial Pain Syndrome and Myofascial Trigger Point Pain, run by Mohamed Tahar Maamouri University Hospital at 1 site in Tunisia.
Trial summary
The goal of this clinical trial is to learn about the performance of botulinum toxin (BTX) injections for bruxism. Participants were divided into two groups according to the duration of the symptoms. Read more about this study
- Who is it for?
- Ages 37 to 61 years
- Conditions the study is for
- Myofascial Pain Syndrome, Myofascial Trigger Point Pain, Bruxism
- What is being tested?
- Abobotulinumtoxin A injection for bruxism
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Sep 2009to 30 Dec 2017
- Phase
- Interventional
- 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 37 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who self-reported having awake bruxism and recovered completely following BTX injections during the period ranging between 2009 and 2015. It includes patients who had previously occlusal splints and who should stop their use once the BTX injections were started.
Who cannot join
- Patients suffering from temporomandibular disorders or having a contraindication to BTX injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Therapeutic Use of Botulinum Toxin in the Treatment of Bruxism: A Retrospective Study
The goal of this clinical trial is to learn about the performance of botulinum toxin (BTX) injections for bruxism. Participants were divided into two groups according to the duration of the symptoms. The main question is whether BTX should be reserved for long-standing bruxism where the conventional methods failed or indicated as a first-line treatment. The investigator also compared the required doses and the frequency of treatment sessions between these two groups for a complete recovery.
Read the detailed description
The effectiveness of botulinum toxin (BTX) in treating bruxism is recognized and well-established. This study aims to provide the most suitable condition for a better performance of BTX injections.
This retrospective study of a single-arm trial was conducted using a medical database of 67 patients who suffered from bruxism between 2009 and 2015, and who had total recovery after injection sessions. Patients were divided into two groups based on the duration of their bruxism. The main outcomes measured were: pain relief, the total number of injection sessions until total recovery, doses of BTX used, and recovery duration between two consecutive sessions. The treatment was stopped when bruxism disappeared.
The investigator carried out injections using Dysport (Ipsen Pharma, Germany). The toxin was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U. The patient received the same doses in each session, delivered to trigger points (TrPs). 0.05 ml was injected into each TrP.
The level of statistical significance was set at p < 0,01. The Chi-square test and ANOVA table were used to compare differences according to injection sessions, doses of BTX, TrPs, and recovery duration between the two groups (with long-standing bruxism, and recent bruxism).
- Conditions
- Myofascial Pain Syndrome, Myofascial Trigger Point Pain, Bruxism, Pain
- Being tested
- Abobotulinumtoxin A injection for bruxism
- Keywords
- Botulinum toxin, treatment, bruxism, myofascial pain syndrome
- Medical subject headings
- Myofascial Pain Syndromes, Bruxism, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abobotulinumtoxin A injection for bruxismOther
Also called Botulinum toxin injection for bruxism
Trigger points were detected with careful palpating of the masticatory muscles (masseter and temporalis muscles) of patients suffering from bruxism. Each trigger point received 0,05 lm ol reconstituted solution of Abobotulinumtoxin A. Dysport (Ipsen Pharma, Germany) was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U.
| Study group | Role | What they receive |
|---|---|---|
| Duration of symptoms before BTX injections | Other | All the participants received BTX injections. Informed consent was obtained. Doses and sessions of injections varied between them according to the time of recurrence and the duration of the primary symptoms.
The investigator carried out injections using Dysport (Ipsen Pharma, Germany). The toxin was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U. The patient received the same doses in each session, delivered to TrPs detected by carefully palpating the muscle. 0.05 ml was injected into each TrPs. Receives: Other: Abobotulinumtoxin A injection for bruxism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between doses of BTX and TrPs
The required doses of BTX were compared according to the number of trigger points found in both groups
Measured: 16 to 55 months
Secondary outcomes (2)
Comparison of the rate of injection sessions
The number of session of BTX injection for complete recovery was studied for both groups.
Measured: 16 to 55 months
Correlation of the long standing symptoms and the time to recurrence
The time to recurrence was compared between individuals of both groups.
Measured: 16 to 55 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Sep 2009
- Primary completion30 Dec 2015
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A retrospective cohort study of two samples of participants ( group with long-standing for more than one year, group with recent symptoms for less than one year), with a single-arm trial (all the participants had the same treatment).
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Tahar Maamouri University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imen Turki Mehri, MD, Mohamed Tahar Maamouri University Hospital
- Investigators
- Imen Mehri Turki, Dr, Principal investigator, University hospital Mohamed Tahar Maamouri. Nabeul, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258070
- Sponsor's protocol ID
- University hospital Maamouri
- Acronym
- BTX
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If the study is published in a medical journal, data will be available for researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Therapeutic Use of Botulinum Toxin in the Treatment of Bruxism: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06258070
- Acronym / sponsor ID
- BTX / University hospital Maamouri
- Conditions
- Myofascial Pain Syndrome, Myofascial Trigger Point Pain, Bruxism, Pain
- Keywords
- Botulinum toxin, treatment, bruxism, myofascial pain syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Mohamed Tahar Maamouri University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 14 Feb 2024 (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.
The goal of this clinical trial is to learn about the performance of botulinum toxin (BTX) injections for bruxism. Participants were divided into two groups according to the duration of the symptoms. The main question is whether BTX should be reserved for long-standing bruxism where the conventional methods failed or indicated as a first-line treatment. The investigator also compared the required doses and the frequency of treatment sessions between these two groups for a complete recovery.
Detailed description
The effectiveness of botulinum toxin (BTX) in treating bruxism is recognized and well-established. This study aims to provide the most suitable condition for a better performance of BTX injections.
This retrospective study of a single-arm trial was conducted using a medical database of 67 patients who suffered from bruxism between 2009 and 2015, and who had total recovery after injection sessions. Patients were divided into two groups based on the duration of their bruxism. The main outcomes measured were: pain relief, the total number of injection sessions until total recovery, doses of BTX used, and recovery duration between two consecutive sessions. The treatment was stopped when bruxism disappeared.
The investigator carried out injections using Dysport (Ipsen Pharma, Germany). The toxin was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U. The patient received the same doses in each session, delivered to trigger points (TrPs). 0.05 ml was injected into each TrP.
The level of statistical significance was set at p < 0,01. The Chi-square test and ANOVA table were used to compare differences according to injection sessions, doses of BTX, TrPs, and recovery duration between the two groups (with long-standing bruxism, and recent bruxism).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A retrospective cohort study of two samples of participants ( group with long-standing for more than one year, group with recent symptoms for less than one year), with a single-arm trial (all the participants had the same treatment).
| Arm | Type | Receives |
|---|---|---|
| Duration of symptoms before BTX injections | Other | Other: Abobotulinumtoxin A injection for bruxismAll the participants received BTX injections. Informed consent was obtained. Doses and sessions of injections varied between them according to the time of recurrence and the duration of the primary symptoms. The investigator carried out injections using Dysport (Ipsen Pharma, Germany). The toxin was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U. The patient received the same doses in each session, delivered to TrPs detected by carefully palpating the muscle. 0.05 ml was injected into each TrPs. |
Who may qualify
- Ages
- 37 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients who self-reported having awake bruxism and recovered completely following BTX injections during the period ranging between 2009 and 2015. It includes patients who had previously occlusal splints and who should stop their use once the BTX injections were started.
Key exclusion criteria (1 listed)
- Patients suffering from temporomandibular disorders or having a contraindication to BTX injection.
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 |
|---|---|---|
| Abobotulinumtoxin A injection for bruxismAlso: Botulinum toxin injection for bruxismTrigger points were detected with careful palpating of the masticatory muscles (masseter and temporalis muscles) of patients suffering from bruxism. Each trigger point received 0,05 lm ol reconstituted solution of Abobotulinumtoxin A. Dysport (Ipsen Pharma, Germany) was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U. | Other | Duration of symptoms before BTX injections |
Primary outcome
Correlation between doses of BTX and TrPs
Time frame: 16 to 55 months
The required doses of BTX were compared according to the number of trigger points found in both groups
2 secondary outcomes
Comparison of the rate of injection sessions
Time frame: 16 to 55 months
Correlation of the long standing symptoms and the time to recurrence
Time frame: 16 to 55 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 14 Feb 2024.
- Individual participant dataSharing planned: No. If the study is published in a medical journal, data will be available for researchers.
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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.
Imen Mehri Turki, Dr principal investigator
University hospital Mohamed Tahar Maamouri. Nabeul, Tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abobotulinumtoxin A injection for bruxism in people with Myofascial Pain Syndrome and Myofascial Trigger Point Pain, run by Mohamed Tahar Maamouri University Hospital at 1 site in Tunisia.
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 1 inclusion and 1 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 14 Feb 2024. 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 Tunisia. 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.
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?
Correlation between doses of BTX and TrPs (time frame: 16 to 55 months). 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 14 Feb 2024.