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
About this trial
This is an interventional treatment trial for Bruxism
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.
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
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
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Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism
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