<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/NCT03753529</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/001936</org_study_id>
    <nct_id>NCT03753529</nct_id>
  </id_info>
  <brief_title>Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism</brief_title>
  <official_title>Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis&#xD;
&#xD;
        1. There will be no significant statistical effect of Trigger Point Pressure release and&#xD;
           Deep striking massage on pain level in patients with bruxism.&#xD;
&#xD;
        2. There will be no significant statistical effect of Trigger Point Pressure release and&#xD;
           Deep striking massage on Range of Motion in patients with bruxism.&#xD;
&#xD;
        3. There will be no significant statistical effect of Trigger Point Pressure release and&#xD;
           Deep striking massage on Sleep Quality Index in patients with bruxism.&#xD;
&#xD;
        4. There will be no significant statistical effect of Trigger Point Pressure release and&#xD;
           Deep striking massage on proprioception awareness in patients with bruxism.&#xD;
&#xD;
        5. There will be no significant statistical effect of Trigger Point Pressure release and&#xD;
           Deep striking massage on Stress in patients with bruxism.&#xD;
&#xD;
        6. There will be no significant statistical effect of Trigger Point Pressure release and&#xD;
           Deep striking massage on Anxiety in patients with bruxism.&#xD;
&#xD;
        7. There will be no significant statistical effect of Trigger Point Pressure release and&#xD;
           Deep striking massage on Temporomandibular (TMJ) function in patients with bruxism.&#xD;
&#xD;
        8. There will be no significant statistical effect of Trigger Point Pressure release and&#xD;
           Deep striking massage on Oral Health Impact Profile in patients with bruxism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes of Trigger point pressure pain threshold</measure>
    <time_frame>Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).</time_frame>
    <description>To compare pressure pain threshold (PPT) values for selected muscles (temporalis, masseter, digastric and lateral pterygoid) in patients with bruxism before and after treatment using Pressure Algometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of mandibular range of motion at month of treatment</measure>
    <time_frame>Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).</time_frame>
    <description>Vernier caliper used to measure opening, lateral movements, protraction and retraction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of proprioception awareness</measure>
    <time_frame>Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).</time_frame>
    <description>Measure ability of patient before treatment and after to move mandible to specific angle(measured by vernier caliper) identified before test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).</time_frame>
    <description>Using Perceived Stress Scale to measure stress which consist of 10 items. The 10 items in the scale inquire about feelings and thoughts that tap the degree to which respondents find their current life situation unpredictable, uncontrollable and stressful. Respondents indicate how often in the past month they have felt or thought a certain way on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). The higher the score the higher the perceived stress is. The scale correlates with different psychosocial measures specifically depression, anxiety, and perception of poor health as well as with decreased satisfaction with self, job and life in general.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).</time_frame>
    <description>Measured using the State-triat Anxiety Inventory. It consists of two independent scales, with 20 questions each, measuring anxiety as a trait (in general) and as a state (at the moment). Each question is scored (from 1 to 4), and scores for the scales range from 20 to 80 as follows: mild anxiety (20 to 34); moderate anxiety (35 to 49); high anxiety (50 to 64); and very high anxiety (65 to 80).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of quality of sleep at month of treatment</measure>
    <time_frame>Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).</time_frame>
    <description>Using The Pittsburgh Sleep Quality Index, It consists of 19 questions grouped under seven domains: subjective sleep quality; sleep latency; sleep duration; usual sleep efficiency; sleep disturbances; use of medications; and diurnal dysfunction. Each domain is scored (0 to 3) and a total score (0 to 21) is calculated as follows: scores ranging from 0 to 4 are indicative of good sleep quality; scores from 5 to 10 suggest poor sleep quality; scores above 10 are suggestive of sleep disorders. Five other questions are answered by participants' spouses or partners, and further characterize sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temporomandibular (TMJ) function</measure>
    <time_frame>Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).</time_frame>
    <description>Using Temporomandibular Disorder (TMD) Disability Index Questionnaire,The TMD Disability Index consists of ten questions regarding disability associated with TMD, and each question is scored from 0-4. Higher scores represent greater levels of disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Oral Health Impact Profile.</measure>
    <time_frame>Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).</time_frame>
    <description>using Oral Health Impact Profile.(OHIP), The OHIP-14 is a 14-items questionnaire designed to measure self-reported functional limitation that focuses on seven dimensions of impact (functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability and handicap) with participants being asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4) using a twelve-months recall period.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Bruxism</condition>
  <condition>TMJ Pain</condition>
  <arm_group>
    <arm_group_label>deep friction massage group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>pressure release group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Deep friction massage</intervention_name>
    <description>Submitted to three session weekly 30-minute sessions of therapy will performed by the administration of sliding and kneading maneuvers of the masseter and temporalis muscles, bilaterally,lateral pterygoid and digastric over four consecutive weeks (total:12 sessions) Sliding consisted of a unidirectional movement in which part of the therapist's hand (mainly the fingertips) will used, moving from the proximal to the distal portion of the face with constant, progressive pressure compatible with the status of each tissue. The degree of pressure varied depending on the level of pain, sensitivity and tension in each individual. Kneading consisted of a gripping maneuver of a muscle group or portion of a muscle.Then follow-up with a passive stretch to the muscle. This will repeated for three to five times for three sessions per week for 4 weeks.</description>
    <arm_group_label>deep friction massage group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pressure release</intervention_name>
    <description>First, using a pincer grasp moved throughout the fibers of the pterygoid, masseter, digastric and temporalis muscles to palpate the muscle aiming to locate a trigger point . A common location is detected according to Simon and Travell book. Once located on the trigger point, apply an IC by gradually applying pressure to the trigger point with your thumb. Keep in communication with the patient, checking to ensure that in staying within the limits of his pain tolerance. Hold this technique for approximately 20 seconds to 1 minute, patient tells you that pain has diminished, or until feels the muscle fibers begin to relax under your pressure. Once feel this release, gradually release pressure. All identified trigger points were treated. Then follow-up with a passive stretch to the muscle. This will repeated for three to five times for three sessions per week for 4 weeks.</description>
    <arm_group_label>pressure release group</arm_group_label>
    <other_name>Ischemic pressure and ischemic compression (IC)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control group</intervention_name>
    <description>Stretching and transcutaneous electrical nerve stimulation</description>
    <arm_group_label>control group</arm_group_label>
    <other_name>Stretching and transcutaneous electrical nerve stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The volunteers diagnosed with bruxism based on the criteria of the American Academy of&#xD;
             Sleep Medicine&#xD;
&#xD;
          2. Positive self-report of awake bruxism.&#xD;
&#xD;
          3. Self-report of muscle fatigue or tenderness on awakening.&#xD;
&#xD;
          4. Sleeping partner reports of grinding sounds during the night in the last 6 months, or&#xD;
             awake clenching.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe psychological disorder and/or the use of antipsychotic psychotropic drugs(with&#xD;
             the exception of anxiety and depression).&#xD;
&#xD;
          2. Using medications that influence sleep or motor behavior.&#xD;
&#xD;
          3. Direct trauma or past surgery in the orofacial region.&#xD;
&#xD;
          4. On physical, speech, dental, or psychological therapy at the time of study entry.&#xD;
&#xD;
          5. Currently undergoing physical therapy for TMD.&#xD;
&#xD;
          6. Neurological or central nervous system and/or peripheral nervous system disorders or&#xD;
             history of neuromuscular disease.&#xD;
&#xD;
          7. The presence of prosthesis or extensive prosthetic restorations and the presence of&#xD;
             gross malocclusion.&#xD;
&#xD;
          8. More than two missing teeth, except third molars;&#xD;
&#xD;
          9. Systemic and/or degenerative diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 2, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 22, 2018</last_update_submitted>
  <last_update_submitted_qc>November 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>HAhmed</investigator_full_name>
    <investigator_title>lecture of biomechanics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bruxism</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03753529
org study id: P.T.REC/012/001936
nct id: NCT03753529
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypothesis

        1. There will be no significant statistical effect of Trigger Point Pressure release and
           Deep striking massage on pain level in patients with bruxism.

        2. There will be no significant statistical effect of Trigger Point Pressure release and
           Deep striking massage on Range of Motion in patients with bruxism.

        3. There will be no significant statistical effect of Trigger Point Pressure release and
           Deep striking massage on Sleep Quality Index in patients with bruxism.

        4. There will be no significant statistical effect of Trigger Point Pressure release and
           Deep striking massage on proprioception awareness in patients with bruxism.

        5. There will be no significant statistical effect of Trigger Point Pressure release and
           Deep striking massage on Stress in patients with bruxism.

        6. There will be no significant statistical effect of Trigger Point Pressure release and
           Deep striking massage on Anxiety in patients with bruxism.

        7. There will be no significant statistical effect of Trigger Point Pressure release and
           Deep striking massage on Temporomandibular (TMJ) function in patients with bruxism.

        8. There will be no significant statistical effect of Trigger Point Pressure release and
           Deep striking massage on Oral Health Impact Profile in patients with bruxism.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: changes of Trigger point pressure pain threshold
time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
description: To compare pressure pain threshold (PPT) values for selected muscles (temporalis, masseter, digastric and lateral pterygoid) in patients with bruxism before and after treatment using Pressure Algometer.
measure: Changes of mandibular range of motion at month of treatment
time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
description: Vernier caliper used to measure opening, lateral movements, protraction and retraction.
measure: Changes of proprioception awareness
time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
description: Measure ability of patient before treatment and after to move mandible to specific angle(measured by vernier caliper) identified before test
measure: Stress
time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
description: Using Perceived Stress Scale to measure stress which consist of 10 items. The 10 items in the scale inquire about feelings and thoughts that tap the degree to which respondents find their current life situation unpredictable, uncontrollable and stressful. Respondents indicate how often in the past month they have felt or thought a certain way on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). The higher the score the higher the perceived stress is. The scale correlates with different psychosocial measures specifically depression, anxiety, and perception of poor health as well as with decreased satisfaction with self, job and life in general.
measure: Anxiety
time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
description: Measured using the State-triat Anxiety Inventory. It consists of two independent scales, with 20 questions each, measuring anxiety as a trait (in general) and as a state (at the moment). Each question is scored (from 1 to 4), and scores for the scales range from 20 to 80 as follows: mild anxiety (20 to 34); moderate anxiety (35 to 49); high anxiety (50 to 64); and very high anxiety (65 to 80).
measure: Changes of quality of sleep at month of treatment
time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
description: Using The Pittsburgh Sleep Quality Index, It consists of 19 questions grouped under seven domains: subjective sleep quality; sleep latency; sleep duration; usual sleep efficiency; sleep disturbances; use of medications; and diurnal dysfunction. Each domain is scored (0 to 3) and a total score (0 to 21) is calculated as follows: scores ranging from 0 to 4 are indicative of good sleep quality; scores from 5 to 10 suggest poor sleep quality; scores above 10 are suggestive of sleep disorders. Five other questions are answered by participants' spouses or partners, and further characterize sleep quality.
measure: Temporomandibular (TMJ) function
time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
description: Using Temporomandibular Disorder (TMD) Disability Index Questionnaire,The TMD Disability Index consists of ten questions regarding disability associated with TMD, and each question is scored from 0-4. Higher scores represent greater levels of disability.
measure: Changes in Oral Health Impact Profile.
time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
description: using Oral Health Impact Profile.(OHIP), The OHIP-14 is a 14-items questionnaire designed to measure self-reported functional limitation that focuses on seven dimensions of impact (functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability and handicap) with participants being asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4) using a twelve-months recall period.
arm group label: deep friction massage group
arm group type: Experimental
arm group label: pressure release group
arm group type: Experimental
arm group label: control group
arm group type: Experimental
intervention type: Other
intervention name: Deep friction massage
description: Submitted to three session weekly 30-minute sessions of therapy will performed by the administration of sliding and kneading maneuvers of the masseter and temporalis muscles, bilaterally,lateral pterygoid and digastric over four consecutive weeks (total:12 sessions) Sliding consisted of a unidirectional movement in which part of the therapist's hand (mainly the fingertips) will used, moving from the proximal to the distal portion of the face with constant, progressive pressure compatible with the status of each tissue. The degree of pressure varied depending on the level of pain, sensitivity and tension in each individual. Kneading consisted of a gripping maneuver of a muscle group or portion of a muscle.Then follow-up with a passive stretch to the muscle. This will repeated for three to five times for three sessions per week for 4 weeks.
arm group label: deep friction massage group
intervention type: Other
intervention name: Pressure release
description: First, using a pincer grasp moved throughout the fibers of the pterygoid, masseter, digastric and temporalis muscles to palpate the muscle aiming to locate a trigger point . A common location is detected according to Simon and Travell book. Once located on the trigger point, apply an IC by gradually applying pressure to the trigger point with your thumb. Keep in communication with the patient, checking to ensure that in staying within the limits of his pain tolerance. Hold this technique for approximately 20 seconds to 1 minute, patient tells you that pain has diminished, or until feels the muscle fibers begin to relax under your pressure. Once feel this release, gradually release pressure. All identified trigger points were treated. Then follow-up with a passive stretch to the muscle. This will repeated for three to five times for three sessions per week for 4 weeks.
arm group label: pressure release group
other name: Ischemic pressure and ischemic compression (IC)
intervention type: Other
intervention name: control group
description: Stretching and transcutaneous electrical nerve stimulation
arm group label: control group
other name: Stretching and transcutaneous electrical nerve stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: HAhmed
investigator title: lecture of biomechanics
mesh term: Bruxism