search
Back to results

Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism

Primary Purpose

Bruxism, TMJ Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deep friction massage
Pressure release
control group
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bruxism

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The volunteers diagnosed with bruxism based on the criteria of the American Academy of Sleep Medicine
  2. Positive self-report of awake bruxism.
  3. Self-report of muscle fatigue or tenderness on awakening.
  4. Sleeping partner reports of grinding sounds during the night in the last 6 months, or awake clenching.

Exclusion Criteria:

  1. Severe psychological disorder and/or the use of antipsychotic psychotropic drugs(with the exception of anxiety and depression).
  2. Using medications that influence sleep or motor behavior.
  3. Direct trauma or past surgery in the orofacial region.
  4. On physical, speech, dental, or psychological therapy at the time of study entry.
  5. Currently undergoing physical therapy for TMD.
  6. Neurological or central nervous system and/or peripheral nervous system disorders or history of neuromuscular disease.
  7. The presence of prosthesis or extensive prosthetic restorations and the presence of gross malocclusion.
  8. More than two missing teeth, except third molars;
  9. Systemic and/or degenerative diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    deep friction massage group

    pressure release group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    changes of Trigger point pressure pain threshold
    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.
    Changes of mandibular range of motion at month of treatment
    Vernier caliper used to measure opening, lateral movements, protraction and retraction.

    Secondary Outcome Measures

    Changes of proprioception awareness
    Measure ability of patient before treatment and after to move mandible to specific angle(measured by vernier caliper) identified before test
    Stress
    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.
    Anxiety
    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).
    Changes of quality of sleep at month of treatment
    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.
    Temporomandibular (TMJ) function
    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.
    Changes in Oral Health Impact Profile.
    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.

    Full Information

    First Posted
    November 2, 2018
    Last Updated
    November 22, 2018
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03753529
    Brief Title
    Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism
    Official Title
    Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    May 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hypothesis There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on pain level in patients with bruxism. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Range of Motion in patients with bruxism. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Sleep Quality Index in patients with bruxism. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on proprioception awareness in patients with bruxism. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Stress in patients with bruxism. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Anxiety in patients with bruxism. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Temporomandibular (TMJ) function in patients with bruxism. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bruxism, TMJ Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    deep friction massage group
    Arm Type
    Experimental
    Arm Title
    pressure release group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Deep friction massage
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Pressure release
    Other Intervention Name(s)
    Ischemic pressure and ischemic compression (IC)
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    control group
    Other Intervention Name(s)
    Stretching and transcutaneous electrical nerve stimulation
    Intervention Description
    Stretching and transcutaneous electrical nerve stimulation
    Primary Outcome Measure Information:
    Title
    changes of Trigger point pressure pain threshold
    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.
    Time Frame
    Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
    Title
    Changes of mandibular range of motion at month of treatment
    Description
    Vernier caliper used to measure opening, lateral movements, protraction and retraction.
    Time Frame
    Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
    Secondary Outcome Measure Information:
    Title
    Changes of proprioception awareness
    Description
    Measure ability of patient before treatment and after to move mandible to specific angle(measured by vernier caliper) identified before test
    Time Frame
    Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
    Title
    Stress
    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.
    Time Frame
    Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
    Title
    Anxiety
    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).
    Time Frame
    Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
    Title
    Changes of quality of sleep at month of treatment
    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.
    Time Frame
    Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
    Title
    Temporomandibular (TMJ) function
    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.
    Time Frame
    Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
    Title
    Changes in Oral Health Impact Profile.
    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.
    Time Frame
    Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The volunteers diagnosed with bruxism based on the criteria of the American Academy of Sleep Medicine Positive self-report of awake bruxism. Self-report of muscle fatigue or tenderness on awakening. Sleeping partner reports of grinding sounds during the night in the last 6 months, or awake clenching. Exclusion Criteria: Severe psychological disorder and/or the use of antipsychotic psychotropic drugs(with the exception of anxiety and depression). Using medications that influence sleep or motor behavior. Direct trauma or past surgery in the orofacial region. On physical, speech, dental, or psychological therapy at the time of study entry. Currently undergoing physical therapy for TMD. Neurological or central nervous system and/or peripheral nervous system disorders or history of neuromuscular disease. The presence of prosthesis or extensive prosthetic restorations and the presence of gross malocclusion. More than two missing teeth, except third molars; Systemic and/or degenerative diseases.

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism

    We'll reach out to this number within 24 hrs