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Efficacy of conventional and BoNTA treatment in patients with Temporomandibular (TMD) disorder

Efficacy of conventional and BoNTA treatment in patients with Temporomandibular (TMD) chronic pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2d4vvv
Enrollment
Unknown
Registered
2019-11-19
Start date
2014-04-04
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Temporomandibular disorder

Interventions

Treated Group (group T): 20 females volunteers received treatment with counseling and injection of 50U of botulinum toxin in the masseter muscles and 20U in the temporal muscles in a single session wi
Drug
Device
Radiation

Sponsors

Faculdade de Odontologia de Piracicaba, Universidade estadual de Campinas
Lead Sponsor
Faculdade de Odontologia de Piracicaba, Universidade estadual de Campinas
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Female volunteers; aged 18-45 years; with muscular TMD; with pain for more than 3 months; using contraception; with all teeth; class I of Angle; having stable occlusion.

Exclusion criteria

Exclusion criteria: Volunteers with trauma in the face and TMJ; with bruxism; wearing dentures; on orthodontic treatment; using anti-inflammatory medication, analgesic and / or muscle relaxant; with coagulopathy; with neuralgia; with arthritis; osteoarthritis; diabetes; neurological disorders; primary headache; fibromialgy.

Design outcomes

Primary

MeasureTime frame
Pain reduction verified through the methods of Visual Analog Scale (VAS) and Pain to Pressure Threshold (LDP), from the evidence of a decrease of at least 2 points in VAS and 5% in LDP before intervention and 7,14,21,28,90 e 180 days after intervention.;Pain reduction in a period of six months, verified through the methods of Visual Analog Scale (VAS) and Pain to Pressure Threshold (LDP), from the evidence of a decrease of at least 2 points in VAS and 5% in LDP in pre and post intervention measurements.

Secondary

MeasureTime frame
Reduction in chewing efficiency over a six-month period, verified by the sieve fractionation method, based on evidence of at least 15% decrease in pre and post-intervention measurements.;Decrease in mandibular bone volume over a period of six months, verified by the conical beam computerized tomography method, based on evidence of a decrease of at least 5% in pre and post-intervention measurements.;Decrease in muscle thickness of the masseter and temporal muscles over a period of six months, verified by the ultrasound method, with evidence of a decrease of at least 5% in pre and post-intervention measurements.;Decrease in the electrical activity of the masseter and temporal muscles over a period of six months, verified by the surface electromyography method, from the evidence of a decrease of at least 10% in the pre and post intervention measurements.

Countries

Brazil

Contacts

Public ContactGiancarlo De la Torre

Faculdade de Odontologia de Piracicaba, Universidade estadual de Campinas

giank_28@hotmail.com+5519971415148

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 12, 2026