The Effect on Envelope of Motion in Asymptomatic Bruxers

NCT ID: NCT05604729

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-12-31

Brief Summary

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Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.

Detailed Description

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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

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Tooth Wear Bruxism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Computerised randomisation, colour coded intervention.

Study Groups

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BoNT A (botulinum neurotoxin type A)

Botulinum neurotoxin, 25 units (U) into each masseter at three sessions.

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type DRUG

Botulinum Neurotoxin type A

Placebo

Saline solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline solution

Control

Saline solution, no tooth wear

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline solution

Interventions

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Botulinum toxin type A

Botulinum Neurotoxin type A

Intervention Type DRUG

Placebo

Saline solution

Intervention Type DRUG

Other Intervention Names

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Xeomin Isotonic solution

Eligibility Criteria

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Inclusion Criteria

• Tooth wear into dentin.

Exclusion Criteria

* No temporomandibular pathology.
* No drugs affecting the central nervous system.
* No conditions affecting muscles or central nervous system.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umeå University

OTHER

Sponsor Role collaborator

Region Västerbotten

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mattias Pettersson, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

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Norrlands universitetssjukhus

Umeå, Västerbotten County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Martin Ågren, MScDS

Role: CONTACT

+46907850000

Facility Contacts

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Martin Ågren, MScDS

Role: primary

Other Identifiers

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BoNT A - Morphology

Identifier Type: -

Identifier Source: org_study_id

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