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Clinical Performance of Therapeutic Use of BTX for Bruxism

NCT06258070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-02-14

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about the performance of botulinum toxin (BTX) injections for bruxism. Participants were divided into two groups according to the duration of the symptoms. The main question is whether BTX should be reserved for long-standing bruxism where the conventional methods failed or indicated as a first-line treatment. The investigator also compared the required doses and the frequency of treatment sessions between these two groups for a complete recovery.

Conditions

  • Myofascial Pain Syndrome
  • Myofascial Trigger Point Pain
  • Bruxism
  • Pain

Interventions

OTHER

Abobotulinumtoxin A injection for bruxism

Trigger points were detected with careful palpating of the masticatory muscles (masseter and temporalis muscles) of patients suffering from bruxism. Each trigger point received 0,05 lm ol reconstituted solution of Abobotulinumtoxin A. Dysport (Ipsen Pharma, Germany) was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U.

Sponsors & Collaborators

  • Mohamed Tahar Maamouri University Hospital

    lead OTHER

Principal Investigators

  • Imen Mehri Turki, Dr · University hospital Mohamed Tahar Maamouri. Nabeul, Tunisia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
37 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-01
Primary Completion
2015-12-30
Completion
2017-12-30

Countries

  • Tunisia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06258070 on ClinicalTrials.gov