Clinical trial NCT05980559: Evaluation of BTX Injections in Treatment of Bruxism
Official title: Evaluation of Botulinum Toxin Injection in Treatment of Bruxism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Bruxism
Keywords: Botulinum toxin
Electromyographic
occlusense
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of this study is to evaluate the effect of botulinum toxin type A (Xeomin®) on patients complaining from bruxism.

The study will be a one arm clinical trial. Twelve subjects reporting bruxism irresponsive to conventional treatment modalities will be recruited and will be injected with botulinum toxin A (Xeomin®) in both masseter and temporalis muscles. Pain levels, Electromyographic activity and maximum occlusal force will be recorded in the subjects before injection and at 1 and 3 months after injection to determine the effect of treatment

Detailed description: Bruxism is a parafunctional activity of the masticatory muscles, characterized by jaw clenching and/or tooth grinding. It was suggested in international consensus conference that bruxism should have two distinct definitions. Sleep bruxism is a muscular action, either rhythmic or not, that takes place while sleeping, and an Awake bruxism which is a muscle disorder characterized by repeated or prolonged teeth contact with clenching of the jaw.

Bruxism is a highly prevalent condition. More than 85% of the general population admit to bruxism at some time during their life. According to reports, the prevalence of awake bruxism is about 24% in the adult population, while the prevalence of bruxism when sleeping is estimated to be around 16% of the same population.

The three muscles that responsible for the jaw closure and the majority of the biting force is the masseter, temporalis, and medial pterygoid muscles. About 43% of the intrinsic strength of jaw closure comes from the masseter, 36% from the temporalis, and 21% from the medial pterygoid.

The diagnosis of bruxism is made on the basis of self-reporting of clenching or grinding the teeth, as well as evaluating tooth mobility, tooth wear, bruxism-related sounds, or jaw muscle pain and other clinical findings of the temporo-mandibular joint (TMJ).

Bruxism has been noted in dentistry as a risk factor for tooth fracture and dental prosthesis damage, periodontal disease and possibly pain in the teeth, jaw, masticatory muscles, and temporo-mandibular joint. The etiology and pathophysiology of bruxism are still unknown, despite several potential causes have been suggested, including emotional stress, neurological diseases, specific medications, and occlusal interferences.

Physical therapy, occlusal splints, and pharmacological management have all been investigated as potential treatment modalities for bruxism, but they have not been proven to be completely effective because they mostly treat patients' symptoms and signs rather than treating the underlying cause of the condition. These treatment modalities helped only in limiting the damaging effects of bruxism on the anatomical structures.

Irreversible occlusal correction has been found ineffective and it is not supported by the available research. Occlusal splints have been applied to prevent overloading the temporomandibular joint elements and muscles of the jaw in addition to prevent tooth attrition. The efficacy of occlusal splints has given conflicting results.

Botulinum toxin (Botox) is currently known to be a useful treatment for a wide range of neurological conditions, and it is used for its therapeutic and cosmetic effect. It is formed by the anaerobic bacterium Clostridium botulinum and has paralytic properties as it can inhibit acetylcholine release, which can ultimately inhibit muscle contraction. Botulinum toxin comes in seven forms : A, B, C, D, E, F, and G. Type A, which cleaves the plasma protein SNAP-25, is the most commonly used commercially and clinically. It is injected intramuscularly, and its effect lasts between three and six months and this transient denervation depends on the dose and volume of toxin.

Since bruxism is caused by involuntary spasms of the jaw muscles, botulinum toxin has been experimented; initial results show that it is safe and effective. The injections generally take one week to start working and two weeks for a full effect, which lasts on average three to six months, and slowly wears off.

The purpose of this study is to evaluate the efficacy of injecting botulinum toxin A into the masseter muscle in participants with bruxism, using a pain scale, Electromyography and occlusense device.

The null hypothesis tested in this study is that there will be no significant difference in the pain level, muscles contractility and biting forces in patients injected with botulinum toxin

Eligibility criteria: Inclusion Criteria:

1. Patient between 20 and 60 years of age.
2. Pain related to the masseter muscles and TMJ area due to bruxism.
3. Patient who has never received botulinum toxins.
4. Patient who did not respond to the conventional treatments (analgesic, physiotherapy, relaxation technique and maxillary retainer).

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Neuromuscular diseases, including neurogenic impairment of the face and patients with underlying neurological disorders.
3. Patients with epilepsy or a previous seizure episode.
4. Injection site infection (masseter or temporalis).
5. Hypersensitivity or allergy to botulinum toxin or any of its excipients.

Primary outcomes:
measure: Change in electromyographic activity of temporalis and masseter muscles bilaterally.
timeFrame: Assessment will be done before the injection versus 1 and 3 months after injection
Secondary outcomes:
measure: Change in Pain Assessment
timeFrame: Assessment will be done before the injection versus 1 and 3 months after injection
measure: Change in maximum bite force
timeFrame: Assessment will be done before the injection versus 1 and 3 months after injection
measure: Change in Bruxism symptom questionnaire
timeFrame: questionnaire will be done before the injection versus 1 and 3 months after injection
Other outcomes:
Locations:
Study officials:
affiliation: Alexandria University
name: Ragab S. Hassan, Professor
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Gaafar N. Elhalawani, Lecturer
role: STUDY_CHAIR
affiliation: University of Alexandria
name: Walaa A. Elwakil, Lecturer
role: STUDY_CHAIR
affiliation: Alexandria University
name: Marwa M. Mancy, Bachelors
role: PRINCIPAL_INVESTIGATOR
References: