Clinical Performance of Therapeutic Use of BTX for Bruxism (BTX)

February 12, 2024 updated by: Imen Turki Mehri, MD, Mohamed Tahar Maamouri University Hospital

Clinical Performance of Therapeutic Use of Botulinum Toxin in the Treatment of Bruxism: A Retrospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effectiveness of botulinum toxin (BTX) in treating bruxism is recognized and well-established. This study aims to provide the most suitable condition for a better performance of BTX injections.

This retrospective study of a single-arm trial was conducted using a medical database of 67 patients who suffered from bruxism between 2009 and 2015, and who had total recovery after injection sessions. Patients were divided into two groups based on the duration of their bruxism. The main outcomes measured were: pain relief, the total number of injection sessions until total recovery, doses of BTX used, and recovery duration between two consecutive sessions. The treatment was stopped when bruxism disappeared.

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 trigger points (TrPs). 0.05 ml was injected into each TrP.

The level of statistical significance was set at p < 0,01. The Chi-square test and ANOVA table were used to compare differences according to injection sessions, doses of BTX, TrPs, and recovery duration between the two groups (with long-standing bruxism, and recent bruxism).

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Nabeul, Tunisia, 8000
        • Imen Mehri Turki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Duration of symptoms before BTX injections

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
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.
Other Names:
  • Botulinum toxin injection for bruxism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between doses of BTX and TrPs
Time Frame: 16 to 55 months
The required doses of BTX were compared according to the number of trigger points found in both groups
16 to 55 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the rate of injection sessions
Time Frame: 16 to 55 months
The number of session of BTX injection for complete recovery was studied for both groups.
16 to 55 months
Correlation of the long standing symptoms and the time to recurrence
Time Frame: 16 to 55 months
The time to recurrence was compared between individuals of both groups.
16 to 55 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Tahar Maamouri University Hospital

Investigators

  • Principal Investigator: Imen Mehri Turki, Dr, University hospital Mohamed Tahar Maamouri. Nabeul, Tunisia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

December 30, 2015

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

January 20, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University hospital Maamouri

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If the study is published in a medical journal, data will be available for researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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