NCT03456154

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

2.8 years

First QC Date

February 28, 2018

Last Update Submit

May 18, 2021

Conditions

Pain, Face

Outcome Measures

Primary Outcomes (1)

  • Masticatory muscle pain

    VAS will be used to assess decrease of pain

    baseline, 3 and 6 months

Secondary Outcomes (2)

  • Oral health related quality of life

    baseline, 3 and 6 months

  • Cervical Position

    baseline, 3 and 6 months

Study Arms (2)

Botox

EXPERIMENTAL

In this group patients will receive 3 injections of botox on each masseter (left and right), after randomization. This injection will be performed once, and the patient will be evaluated after 3 and 6 months after this day.

Drug: Botox Injectable Product

Occlusal splint

ACTIVE COMPARATOR

In this group patients will receive an occlusal splint, which will be manufactured after taking their full mouth impression. This appliance has to be worn everyday, for 6 months, at night.

Device: Occlusal splint

Interventions

Botox Injectable ProductDRUG

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

Botox
Occlusal splintDEVICE

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

Occlusal splint

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015560, Brazil

Location

Related Publications (2)

  • Pires ALC, Galdino Santos L, Poletto-Neto V, Luz MS, Damian MF, Pereira-Cenci T. Evaluation of craniocervical posture after myofascial pain treatment in adults with bruxism: A randomized clinical trial. J Bodyw Mov Ther. 2024 Oct;40:1795-1801. doi: 10.1016/j.jbmt.2024.10.032. Epub 2024 Oct 16.

    PMID: 39593526DERIVED

  • Chisini LA, Pires ALC, Poletto-Neto V, Damian MF, Luz MS, Loomans B, Pereira-Cenci T. Occlusal splint or botulinum toxin-a for jaw muscle pain treatment in probable sleep bruxism: A randomized controlled trial. J Dent. 2024 Dec;151:105439. doi: 10.1016/j.jdent.2024.105439. Epub 2024 Nov 5.

    PMID: 39510242DERIVED

MeSH Terms

Conditions

Facial Pain

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 7, 2018

Study Start

March 15, 2018

Primary Completion

January 15, 2021

Study Completion

March 1, 2021

Last Updated

May 20, 2021

Record last verified: 2021-05

Locations

BR(1)