Botulinumtoxin A as a treatment for myalgia and myofacial pain in patient with temporomandibulardisorders – a quality study associated to a new treatment routine.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504033-44-00

Acronym

BTXclinicaltrialEA

Enrollment

Registered

2024-02-05

Start date

2025-05-01

Completion date

Unknown

Last updated

2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular disorder

Brief summary

Changes in pain and if the dose matters for pain relief is the primary outcome.

Detailed description

Changes in quality of life according to OHIP. Treatment outcome in sub-groups of myogenous TMD. Maximum jaw opening with and without pain between doses and subgroups. The patient´s changes psychosocially, how the jawfunction is affected according to changes in Axis II and changes in PPT.

Interventions

DRUGCLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD)

DRUGFREE OF COMPLEXING PROTEINS

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Changes in pain and if the dose matters for pain relief is the primary outcome.	—

Secondary

Measure	Time frame
Changes in quality of life according to OHIP. Treatment outcome in sub-groups of myogenous TMD. Maximum jaw opening with and without pain between doses and subgroups. The patient´s changes psychosocially, how the jawfunction is affected according to changes in Axis II and changes in PPT.	—

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026