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Acrylic splints for treating chronic muscle pain in patients with TMD: randomized clinical trial

Total and partial splints in the treatment of chronic myalgia in patients with TMD: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2n2nfp6
Enrollment
Unknown
Registered
2023-09-28
Start date
2023-11-20
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 Joint Disorders

Interventions

This is a randomized clinical trial, paralell, blinded. The sample will consist of 90 participants who have had myalgias related to temporomandibular disorder (TMD) for longer than 6 months and who wi
GII (n=30) treated with the anterior partial splint
GIII (n=30) control group that will receive guidelines for self-care. Randomization will be kept in sealed envelopes, being opened only at the time of intervention. The initial assessments of patients

Sponsors

Universidade Federal dos Vales do Jequitinhonha e Mucuri
Collaborator
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Lead Sponsor

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Having myalgias related to Temporomandibular Disorders (TMDs) for longer than 6 months; myalgias located in the temporal region accompanied, or not, by other facial myalgias; be aged 18 years or over; both genders; pain on palpation with a score greater than or equal to 7 on the numeric rating scale; pain related to functional and/or parafunctional activities of the stomatognathic system

Exclusion criteria

Exclusion criteria: Patient undergoing physiotherapeutic and/or speech therapy treatments that have repercussions on muscle, joint and/or skeletal structures in the head and neck region; who have undergone some type of temporomandibular joint procedure in the last 12 months; patients with facial paralysis; patients undergoing orthodontic treatment; complete denture users; who underwent a procedure using botulinum toxin in the head and neck region in the last 6 months; patients using Selective Serotonin Reuptake Inhibitors (SSRI) antidepressants; patients undergoing psychological treatment; patients who have cognitive and/or neuromotor difficulties that compromise the stages of the study's development

Design outcomes

Primary

MeasureTime frame
Pain: All patients will be instructed to define their pain level on a numerical scale from 0 to 10. This parameter will be evaluated baseline, 1, 3 and 6 months after treatment.

Secondary

MeasureTime frame
Quality of life: participants will respond a oral health related quality of life questionnaire, before and 3 months after treatment.;Adverse effects: participants will report adversal effects correlated to the treatment. This will be evaluated 7 days after the treatment.

Countries

Brazil

Contacts

Public ContactDhelfeson Oliveira

Universidade Federal dos Vales do Jequitinhonha e Mucuri

dhelfeson@ufvjm.edu.br+55(38)35326013

Outcome results

None listed

Source: REBEC (via WHO ICTRP)