The Effect on Envelope of Motion in Asymptomatic Bruxers

Region Västerbotten

Status: Enrolling

Conditions: Tooth Wear; Bruxism

Treatments: Drug: Placebo; Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT05604729

BoNT A - Morphology

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

BoNT A (botulinum neurotoxin type A)

Experimental group

Description:

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

Treatment:

Drug: Botulinum toxin type A

Placebo

Placebo Comparator group

Description:

Saline solution

Treatment:

Drug: Placebo

Control

Placebo Comparator group

Description:

Saline solution, no tooth wear

Treatment:

Drug: Placebo