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Completed

NCT Number: NCT03456154

Botox vs Occlusal Splint for Masseter Pain

This randomized clinical trial will compare the standard treatment (occlusal splint) and botox for the treatment of face muscular pain in adults. Fifty patients will be invited and selected, and allocated to the experimental group, according to the randomization sequence previously performed. For the splint group, a rigid splint will be worn by the patient every night. For the botox group, 60u of botox will be injected in 3 regions of the masseter muscle. Patients will be assessed before the experiment, 3 and 6 months after the beginning of the study. Oral health related quality of life, pain, and cervical neck position will be evaluated. Paired t-test and chi-square will be used for statistical analysis.

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Key information

Conditions

Pain, Face Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015560, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 18 and 70 years old;
  • at least 20 teeth in the mouth;
  • occlusal stability;
  • presenting pain in face muscles.

Exclusion criteria

  • Angle's Class III
  • Kennedy's Class II or I removable partial denture wearer;
  • Complete denture wearer;
  • Individuals that have taken any anti inflammatory drugs in the last 3 months;
  • Individuals with temporomandibular joint disorders.

Treatment and study plan

Botox Injectable Product

Drug

60u will be used at 3 sites of masseter muscle, on each side of the face

Occlusal splint

Device

In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.

Primary outcomes

  1. Masticatory muscle pain

    Time frame: baseline, 3 and 6 months

    VAS will be used to assess decrease of pain

Secondary outcomes

  1. Oral health related quality of life

    Time frame: baseline, 3 and 6 months

    OHIP 14 questionnaire will be applied

  2. Cervical Position

    Time frame: baseline, 3 and 6 months

    Modifications of cervical vertebral column position will be assessed

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

Use of Botox Versus Conventional Treatment for Pain Decrease of Muscular Pain: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 7, 2018
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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