xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05980559</url>
    </required_header>
    <id_info>
      <org_study_id>Botulinum toxin in bruxism</org_study_id>
      <nct_id>NCT05980559</nct_id>
    </id_info>
    <brief_title>Evaluation of BTX Injections in Treatment of Bruxism</brief_title>
    <official_title>Evaluation of Botulinum Toxin Injection in Treatment of Bruxism</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Aim of this study is to evaluate the effect of botulinum toxin type A (Xeomin®) on patients&#xD;
        complaining from bruxism.&#xD;
  &#xD;
        The study will be a one arm clinical trial. Twelve subjects reporting bruxism irresponsive to&#xD;
        conventional treatment modalities will be recruited and will be injected with botulinum toxin&#xD;
        A (Xeomin®) in both masseter and temporalis muscles. Pain levels, Electromyographic activity&#xD;
        and maximum occlusal force will be recorded in the subjects before injection and at 1 and 3&#xD;
        months after injection to determine the effect of treatment&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Bruxism is a parafunctional activity of the masticatory muscles, characterized by jaw&#xD;
        clenching and/or tooth grinding. It was suggested in international consensus conference that&#xD;
        bruxism should have two distinct definitions. Sleep bruxism is a muscular action, either&#xD;
        rhythmic or not, that takes place while sleeping, and an Awake bruxism which is a muscle&#xD;
        disorder characterized by repeated or prolonged teeth contact with clenching of the jaw.&#xD;
  &#xD;
        Bruxism is a highly prevalent condition. More than 85% of the general population admit to&#xD;
        bruxism at some time during their life. According to reports, the prevalence of awake bruxism&#xD;
        is about 24% in the adult population, while the prevalence of bruxism when sleeping is&#xD;
        estimated to be around 16% of the same population.&#xD;
  &#xD;
        The three muscles that responsible for the jaw closure and the majority of the biting force&#xD;
        is the masseter, temporalis, and medial pterygoid muscles. About 43% of the intrinsic&#xD;
        strength of jaw closure comes from the masseter, 36% from the temporalis, and 21% from the&#xD;
        medial pterygoid.&#xD;
  &#xD;
        The diagnosis of bruxism is made on the basis of self-reporting of clenching or grinding the&#xD;
        teeth, as well as evaluating tooth mobility, tooth wear, bruxism-related sounds, or jaw&#xD;
        muscle pain and other clinical findings of the temporo-mandibular joint (TMJ).&#xD;
  &#xD;
        Bruxism has been noted in dentistry as a risk factor for tooth fracture and dental prosthesis&#xD;
        damage, periodontal disease and possibly pain in the teeth, jaw, masticatory muscles, and&#xD;
        temporo-mandibular joint. The etiology and pathophysiology of bruxism are still unknown,&#xD;
        despite several potential causes have been suggested, including emotional stress,&#xD;
        neurological diseases, specific medications, and occlusal interferences.&#xD;
  &#xD;
        Physical therapy, occlusal splints, and pharmacological management have all been investigated&#xD;
        as potential treatment modalities for bruxism, but they have not been proven to be completely&#xD;
        effective because they mostly treat patients' symptoms and signs rather than treating the&#xD;
        underlying cause of the condition. These treatment modalities helped only in limiting the&#xD;
        damaging effects of bruxism on the anatomical structures.&#xD;
  &#xD;
        Irreversible occlusal correction has been found ineffective and it is not supported by the&#xD;
        available research. Occlusal splints have been applied to prevent overloading the&#xD;
        temporomandibular joint elements and muscles of the jaw in addition to prevent tooth&#xD;
        attrition. The efficacy of occlusal splints has given conflicting results.&#xD;
  &#xD;
        Botulinum toxin (Botox) is currently known to be a useful treatment for a wide range of&#xD;
        neurological conditions, and it is used for its therapeutic and cosmetic effect. It is formed&#xD;
        by the anaerobic bacterium Clostridium botulinum and has paralytic properties as it can&#xD;
        inhibit acetylcholine release, which can ultimately inhibit muscle contraction. Botulinum&#xD;
        toxin comes in seven forms : A, B, C, D, E, F, and G. Type A, which cleaves the plasma&#xD;
        protein SNAP-25, is the most commonly used commercially and clinically. It is injected&#xD;
        intramuscularly, and its effect lasts between three and six months and this transient&#xD;
        denervation depends on the dose and volume of toxin.&#xD;
  &#xD;
        Since bruxism is caused by involuntary spasms of the jaw muscles, botulinum toxin has been&#xD;
        experimented; initial results show that it is safe and effective. The injections generally&#xD;
        take one week to start working and two weeks for a full effect, which lasts on average three&#xD;
        to six months, and slowly wears off.&#xD;
  &#xD;
        The purpose of this study is to evaluate the efficacy of injecting botulinum toxin A into the&#xD;
        masseter muscle in participants with bruxism, using a pain scale, Electromyography and&#xD;
        occlusense device.&#xD;
  &#xD;
        The null hypothesis tested in this study is that there will be no significant difference in&#xD;
        the pain level, muscles contractility and biting forces in patients injected with botulinum&#xD;
        toxin&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">January 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in electromyographic activity of temporalis and masseter muscles bilaterally.</measure>
      <time_frame>Assessment will be done before the injection versus 1 and 3 months after injection</time_frame>
      <description>Analyze the electromyographic activity of temporalis and masseter muscles bilaterally. The acquisitions will be performed twice with the rest position of the mandible (RPM) for 10 seconds, in maximal intercuspal position for 5 seconds, and maximal teeth clenching with 10-mm thick cotton rolls between the posterior teeth for 5 seconds, bilaterally, and the median of values will be obtained. The unit of measurement used in the Electromyographic records will be microvolts (μV).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Pain Assessment</measure>
      <time_frame>Assessment will be done before the injection versus 1 and 3 months after injection</time_frame>
      <description>The pain will be measured using a visual analogue scale (VAS). The patient will be asked to mark on a line that measured 100 mm in length where she/he reflected her/his perceived pain. The scores of the scale will be determined by measuring the distance in mm from the beginning to the point indicated by the patient (point (0): no pain and point (100): the highest levels of pain).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in maximum bite force</measure>
      <time_frame>Assessment will be done before the injection versus 1 and 3 months after injection</time_frame>
      <description>Computerized occlusal analysis will be conducted using the Occlusense device to record and analyze the biting force of each patient. The system use a 100-µm thick recording sensor. All scanning procedures will be carried out by the same clinician and at the same time of the day to avoid variability. The size of the sensor, large or small, will be chosen to suit the patient's dental arch. Prior to any occlusal acquisition sensitivity of the device will be adjusted. The patient will be asked to bite on the sensor, and a record for the maximum biting force on the first molar region (key of occlusion).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Bruxism symptom questionnaire</measure>
      <time_frame>questionnaire will be done before the injection versus 1 and 3 months after injection</time_frame>
      <description>to evaluate the subjective bruxism symptoms consisted of three items: (1) How often do you think that you had bruxed at night during the past 1 month? (2) How often have you heard from your sleeping partner that you bruxed during the past 1 month? (3) How often during the past month have you felt jaw stiffness on waking? The responses to each item were based on a 0-5 scale where 0 = none, 1 = very seldom, 2 = seldom, 3 = often (half the mornings), 4 very often, 5 = every day. The rationale was that previous reports have used subjective measures, and we wished to compare our results with the previous data.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Bruxism</condition>
    <arm_group>
      <arm_group_label>One Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be injected with 50 MU of botulinum toxin and Surface qualitative Electromyography, maximum bite force and visual pain scale will be taken before and after 1, 3 months</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Xeomin</intervention_name>
      <description>50 units of Incobotulinumtoxin A (BTX A) Xeomin® Injections into the masseter and temporalis muscles bilaterally (15 Units per muscle applied with 2 injections in each masseter muscle) (10 Units per muscle applied with 2 injections in each temporalis muscle)</description>
      <arm_group_label>One Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patient between 20 and 60 years of age.&#xD;
  &#xD;
            2. Pain related to the masseter muscles and TMJ area due to bruxism.&#xD;
  &#xD;
            3. Patient who has never received botulinum toxins.&#xD;
  &#xD;
            4. Patient who did not respond to the conventional treatments (analgesic, physiotherapy,&#xD;
               relaxation technique and maxillary retainer).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant or breastfeeding women.&#xD;
  &#xD;
            2. Neuromuscular diseases, including neurogenic impairment of the face and patients with&#xD;
               underlying neurological disorders.&#xD;
  &#xD;
            3. Patients with epilepsy or a previous seizure episode.&#xD;
  &#xD;
            4. Injection site infection (masseter or temporalis).&#xD;
  &#xD;
            5. Hypersensitivity or allergy to botulinum toxin or any of its excipients.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ragab S. Hassan, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Gaafar N. Elhalawani, Lecturer</last_name>
      <role>Study Chair</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Walaa A. Elwakil, Lecturer</last_name>
      <role>Study Chair</role>
      <affiliation>University of Alexandria</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Marwa M. Mancy, Bachelors</last_name>
      <role>Principal Investigator</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marwa M. Mohmed, Bachelors</last_name>
      <phone>00201224979900</phone>
      <email>Marwa.mohamed.dent@alexu.edu.eg</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Walaa Ali Elwakil</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Botulinum toxin</keyword>
    <keyword>Electromyographic</keyword>
    <keyword>occlusense</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bruxism</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>incobotulinumtoxinA</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05980559
  org study id: Botulinum toxin in bruxism
  nct id: NCT05980559
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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
  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
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in electromyographic activity of temporalis and masseter muscles bilaterally.
  time frame: Assessment will be done before the injection versus 1 and 3 months after injection
  description: Analyze the electromyographic activity of temporalis and masseter muscles bilaterally. The acquisitions will be performed twice with the rest position of the mandible (RPM) for 10 seconds, in maximal intercuspal position for 5 seconds, and maximal teeth clenching with 10-mm thick cotton rolls between the posterior teeth for 5 seconds, bilaterally, and the median of values will be obtained. The unit of measurement used in the Electromyographic records will be microvolts (μV).
  measure: Change in Pain Assessment
  time frame: Assessment will be done before the injection versus 1 and 3 months after injection
  description: The pain will be measured using a visual analogue scale (VAS). The patient will be asked to mark on a line that measured 100 mm in length where she/he reflected her/his perceived pain. The scores of the scale will be determined by measuring the distance in mm from the beginning to the point indicated by the patient (point (0): no pain and point (100): the highest levels of pain).
  measure: Change in maximum bite force
  time frame: Assessment will be done before the injection versus 1 and 3 months after injection
  description: Computerized occlusal analysis will be conducted using the Occlusense device to record and analyze the biting force of each patient. The system use a 100-µm thick recording sensor. All scanning procedures will be carried out by the same clinician and at the same time of the day to avoid variability. The size of the sensor, large or small, will be chosen to suit the patient's dental arch. Prior to any occlusal acquisition sensitivity of the device will be adjusted. The patient will be asked to bite on the sensor, and a record for the maximum biting force on the first molar region (key of occlusion).
  measure: Change in Bruxism symptom questionnaire
  time frame: questionnaire will be done before the injection versus 1 and 3 months after injection
  description: to evaluate the subjective bruxism symptoms consisted of three items: (1) How often do you think that you had bruxed at night during the past 1 month? (2) How often have you heard from your sleeping partner that you bruxed during the past 1 month? (3) How often during the past month have you felt jaw stiffness on waking? The responses to each item were based on a 0-5 scale where 0 = none, 1 = very seldom, 2 = seldom, 3 = often (half the mornings), 4 very often, 5 = every day. The rationale was that previous reports have used subjective measures, and we wished to compare our results with the previous data.
  arm group label: One Group
  arm group type: Experimental
  description: Patients will be injected with 50 MU of botulinum toxin and Surface qualitative Electromyography, maximum bite force and visual pain scale will be taken before and after 1, 3 months
  intervention type: Drug
  intervention name: Xeomin
  description: 50 units of Incobotulinumtoxin A (BTX A) Xeomin® Injections into the masseter and temporalis muscles bilaterally (15 Units per muscle applied with 2 injections in each masseter muscle) (10 Units per muscle applied with 2 injections in each temporalis muscle)
  arm group label: One Group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Ragab S. Hassan, Professor
  role: Study Director
  affiliation: Alexandria University
  last name: Gaafar N. Elhalawani, Lecturer
  role: Study Chair
  affiliation: Alexandria University
  last name: Walaa A. Elwakil, Lecturer
  role: Study Chair
  affiliation: University of Alexandria
  last name: Marwa M. Mancy, Bachelors
  role: Principal Investigator
  affiliation: Alexandria University
  last name: Marwa M. Mohmed, Bachelors
  phone: 00201224979900
  email: Marwa.mohamed.dent@alexu.edu.eg
  responsible party type: Principal Investigator
  investigator affiliation: Alexandria University
  investigator full name: Walaa Ali Elwakil
  investigator title: Lecturer
  mesh term: Bruxism
  mesh term: incobotulinumtoxinA