Tooth WearNCT05604729
The Effect on Envelope of Motion in Asymptomatic Bruxers
A study testing Botulinum toxin type A in people with Tooth Wear and Bruxism, run by Region Västerbotten at 1 site in Sweden.
Trial summary
Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear, Bruxism
- What is being tested?
- Botulinum toxin type A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2023to 31 Dec 2025
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Tooth wear into dentin.
Who cannot join
- No temporomandibular pathology.
- No drugs affecting the central nervous system.
- No conditions affecting muscles or central nervous system.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Norrlands universitetssjukhus
Umeå, Västerbotten County, 90185
Martin Ågren, MScDS, martin.agren@regionvasterbotten.se
About this study
Official title: The Effect on Envelope of Motion in Asymptomatic Bruxers - A Double Blinded Study
Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.
Read the detailed description
Research subjects will be allocated to placebo or botulinum neurotoxin intervention. A control group will not receive any intervention. The intervention will be administered at three separate sessions with 12 weeks in between. Prior to intervention, and 6 months after last intervention the jaw-neck envelope of motion will be studied using 3D optoelectronic recording systems.
- Conditions
- Tooth Wear, Bruxism
- Being tested
- Botulinum toxin type A, Placebo
- Medical subject headings
- Tooth Wear, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Xeomin
Botulinum Neurotoxin type A
PlaceboDrug
Also called Isotonic solution
Saline solution
| Study group | Role | What they receive |
|---|---|---|
| BoNT A (botulinum neurotoxin type A) | Experimental | Botulinum neurotoxin, 25 units (U) into each masseter at three sessions. Receives: Drug: Botulinum toxin type A |
| Placebo | Placebo comparator | Saline solution Receives: Drug: Placebo |
| Control | Placebo comparator | Saline solution, no tooth wear Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of range of motion
Measured on a cartesian plane in millimeters.
Measured: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Change of envelope of motion
Volume of envelope of motion measured in cubic millimeters.
Measured: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Change of length in chewing cycles
Repetitive chewing cycles, measured in milliseconds.
Measured: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Secondary outcomes (3)
Change of muscle thickness
Masseter muscle thickness measured through ultrasonography
Measured: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
Change of maximal voluntary bite force
Measured through a strain gauge meter
Measured: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
Tooth wear, change of hard tissue mass
Intraoral scanning. Tooth wear measured in cubic millimeters.
Measured: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Sep 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth WearStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Västerbotten
- Sponsor type
- Other government
- Collaborators
- Umeå University
- Responsible party
- Sponsor
- Investigators
- Mattias Pettersson, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604729
- Sponsor's protocol ID
- BoNT A - Morphology
- Status last verified
- May 2023
- First submitted
- 1 Apr 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
- The Effect on Envelope of Motion in Asymptomatic Bruxers - A Double Blinded Study
- ClinicalTrials.gov ID
- NCT05604729
- Acronym / sponsor ID
- BoNT A - Morphology
- Conditions
- Tooth Wear, Bruxism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Region VästerbottenOther government
- Collaborators
- Umeå University
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Nov 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.
Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.
Detailed description
Research subjects will be allocated to placebo or botulinum neurotoxin intervention. A control group will not receive any intervention. The intervention will be administered at three separate sessions with 12 weeks in between. Prior to intervention, and 6 months after last intervention the jaw-neck envelope of motion will be studied using 3D optoelectronic recording systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double blinded
| Arm | Type | Receives |
|---|---|---|
| BoNT A (botulinum neurotoxin type A) | Experimental | Drug: Botulinum toxin type ABotulinum neurotoxin, 25 units (U) into each masseter at three sessions. |
| Placebo | Placebo comparator | Drug: PlaceboSaline solution |
| Control | Placebo comparator | Drug: PlaceboSaline solution, no tooth wear |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Tooth wear into dentin.
Key exclusion criteria (3 listed)
- No temporomandibular pathology.
- No drugs affecting the central nervous system.
- No conditions affecting muscles or 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: XeominBotulinum Neurotoxin type A | Drug | BoNT A (botulinum neurotoxin type A) |
| PlaceboAlso: Isotonic solutionSaline solution | Drug | Control, Placebo |
Primary outcome
Change of range of motion
Time frame: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Measured on a cartesian plane in millimeters.
Change of envelope of motion
Time frame: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Volume of envelope of motion measured in cubic millimeters.
Change of length in chewing cycles
Time frame: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Repetitive chewing cycles, measured in milliseconds.
3 secondary outcomes
Change of muscle thickness
Time frame: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
Change of maximal voluntary bite force
Time frame: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
Tooth wear, change of hard tissue mass
Time frame: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
Results and safety
Results are not available in the source record.
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.
Mattias 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 Tooth Wear and Bruxism, 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 3 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 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Ågren, MScDS (+46907850000, martin.agren@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of range of motion (time frame: Baseline and 6 months after last intervention. Measurements compared to baseline values.). The study lists 3 primary outcomes in all. 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.