Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedNovember 27, 2018
November 1, 2018
1 year
November 2, 2018
November 22, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Changes of mandibular range of motion at month of treatment
Vernier caliper used to measure opening, lateral movements, protraction and retraction.
Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Secondary Outcomes (6)
Changes of proprioception awareness
Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Stress
Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Anxiety
Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Changes of quality of sleep at month of treatment
Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Temporomandibular (TMJ) function
Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
- +1 more secondary outcomes
Study Arms (3)
deep friction massage group
EXPERIMENTALpressure release group
EXPERIMENTALcontrol group
EXPERIMENTALInterventions
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.
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.
Stretching and transcutaneous electrical nerve stimulation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecture of biomechanics
Study Record Dates
First Submitted
November 2, 2018
First Posted
November 27, 2018
Study Start
January 1, 2019
Primary Completion
January 1, 2020
Study Completion
May 1, 2020
Last Updated
November 27, 2018
Record last verified: 2018-11