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Completed

NCT Number: NCT06258070

Clinical Performance of Therapeutic Use of BTX for Bruxism

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.

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Key information

Age range

37 year–61 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imen Mehri Turki

Nabeul, 8000, Tunisia

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Other names: Botulinum toxin injection for bruxism

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mohamed Tahar Maamouri University Hospital

Other

Registry information

Official study title

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

Acronym: BTX

Important dates

Study start
2009
Primary completion
2015
Study completion
2017
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

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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