Bite ForceNCT05309564
Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter
A study testing Botulinum toxin type A in people with Bite Force and Botulinum Toxins, Type A, run by Region Västerbotten at 1 site in Sweden.
Trial summary
This study aimed to evaluate the duration of a reduced maximal voluntary bite force after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH \& Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to… Read more about this study
- Who is it for?
- Ages 18 to 120 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bite Force, Botulinum Toxins, Type A
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2020to 14 Mar 2022
- 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 18 to 120 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.
Who cannot join
- Conditions or drugs affecting the central nervous system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muscle Weakness Duration Post-injection of a Single Dose of Botulinum Toxin in the Masseter Muscle Bilaterally: a One-year Non-randomized Controlled Trial
This study aimed to evaluate the duration of a reduced maximal voluntary bite force after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH \& Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units).
Read the detailed description
This study aimed to evaluate the duration of a reduced maximal voluntary bite force (MVBF) after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH \& Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units). A control group did not receive any intervention. MVBF was measured in Newtons using a strain gauge meter at the incisors and first molars. The intervention group was comprised of individuals seeking aesthetic treatment for masseter reduction (n = 20), and the control group (n = 12) comprised of volunteers.
- Conditions
- Bite Force, Botulinum Toxins, Type A
- Being tested
- Botulinum toxin type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ADrug
Also called Xeomin
Single intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention with single botulinum neurotoxin injection into masseter. Receives: Drug: Botulinum toxin type A |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of bite force
Maximum voluntary bite force measured in Newtons at baseline, and change of bite force compared to baseline.
Measured: Baseline, 4 weeks, 3 months, 6 months, 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Mar 2020
- Primary completion10 Jan 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bite ForceStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Västerbotten
- Sponsor type
- Other government
- Collaborators
- Umeå University, Mahidol University
- Responsible party
- Sponsor
- Investigators
- 2020-03517 Pettersson, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309564
- Sponsor's protocol ID
- BTX-Thailand
- Status last verified
- May 2023
- First submitted
- 14 Mar 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Weakness Duration Post-injection of a Single Dose of Botulinum Toxin in the Masseter Muscle Bilaterally: a One-year Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05309564
- Acronym / sponsor ID
- BTX-Thailand
- Conditions
- Bite Force, Botulinum Toxins, Type A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Region VästerbottenOther government
- Collaborators
- Umeå University, Mahidol University
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 4 Apr 2022 (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 study aimed to evaluate the duration of a reduced maximal voluntary bite force after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH \& Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units).
Detailed description
This study aimed to evaluate the duration of a reduced maximal voluntary bite force (MVBF) after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH \& Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units). A control group did not receive any intervention. MVBF was measured in Newtons using a strain gauge meter at the incisors and first molars. The intervention group was comprised of individuals seeking aesthetic treatment for masseter reduction (n = 20), and the control group (n = 12) comprised of volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Botulinum toxin type AIntervention with single botulinum neurotoxin injection into masseter. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.
Key exclusion criteria (1 listed)
- Conditions or drugs affecting the central nervous system.
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 |
|---|---|---|
| Botulinum toxin type AAlso: XeominSingle intervention | Drug | Intervention |
Primary outcome
Change of bite force
Time frame: Baseline, 4 weeks, 3 months, 6 months, 12 months.
Maximum voluntary bite force measured in Newtons at baseline, and change of bite force compared to baseline.
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 3 May 2023.
- Individual participant dataSharing planned: No
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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.
2020-03517 Pettersson, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A in people with Bite Force and Botulinum Toxins, Type A, run by Region Västerbotten at 1 site in Sweden.
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 3 May 2023. 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 Sweden. 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?
Change of bite force (time frame: Baseline, 4 weeks, 3 months, 6 months, 12 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 3 May 2023.