Clinical Performance of Therapeutic Use of BTX for Bruxism

NCT06258070 | Completed DMC

• 1 other identifier: University hospital Maamouri
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Botulinum toxin; treatment; bruxism; myofascial pain syndrome

Outcome Measures

Primary Outcomes (1)

• Correlation between doses of BTX and TrPs

  The required doses of BTX were compared according to the number of trigger points found in both groups

  16 to 55 months

Secondary Outcomes (2)

• Comparison of the rate of injection sessions

  16 to 55 months

• Correlation of the long standing symptoms and the time to recurrence

  16 to 55 months

Study Arms (1)

Duration of symptoms before BTX injections

OTHER

All the participants received BTX injections. Informed consent was obtained. Doses and sessions of injections varied between them according to the time of recurrence and the duration of the primary symptoms. The investigator carried out injections using Dysport (Ipsen Pharma, Germany). The toxin was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U. The patient received the same doses in each session, delivered to TrPs detected by carefully palpating the muscle. 0.05 ml was injected into each TrPs.

Other: Abobotulinumtoxin A injection for bruxism

Interventions

Abobotulinumtoxin A injection for bruxism OTHER

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.

Also known as: Botulinum toxin injection for bruxism

Duration of symptoms before BTX injections

Eligibility Criteria

• Age: 37 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who self-reported having awake bruxism and recovered completely following BTX injections during the period ranging between 2009 and 2015. It includes patients who had previously occlusal splints and who should stop their use once the BTX injections were started.

You may not qualify if:

• Patients suffering from temporomandibular disorders or having a contraindication to BTX injection.

Sponsors & Collaborators

• Mohamed Tahar Maamouri University Hospital: lead

Study Sites (1)

Imen Mehri Turki

Nabeul, 8000, Tunisia

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Bruxism; Pain

Interventions

abobotulinumtoxinA; Botulinum Toxins

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Imen Mehri Turki, Dr

  University hospital Mohamed Tahar Maamouri. Nabeul, Tunisia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A retrospective cohort study of two samples of participants ( group with long-standing for more than one year, group with recent symptoms for less than one year), with a single-arm trial (all the participants had the same treatment).

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: February 14, 2024
• Study Start: September 1, 2009
• Primary Completion: December 30, 2015
• Study Completion: December 30, 2017
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)