NCT03753529

Brief Summary

Hypothesis

  1. 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. 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. 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. 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. 5.There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Stress in patients with bruxism.
  6. 6.There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Anxiety in patients with bruxism.
  7. 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. 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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Status
unknown

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

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

November 2, 2018

Last Update Submit

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

EXPERIMENTAL
Other: Deep friction massage

pressure release group

EXPERIMENTAL
Other: Pressure release

control group

EXPERIMENTAL
Other: control group

Interventions

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.

deep friction massage group

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.

Also known as: Ischemic pressure and ischemic compression (IC)
pressure release group

Stretching and transcutaneous electrical nerve stimulation

Also known as: Stretching and transcutaneous electrical nerve stimulation
control group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

MeSH Terms

Conditions

Bruxism

Interventions

Continuous Positive Airway PressureAcupressureControl GroupsTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory TherapyTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesPhysical Therapy ModalitiesRehabilitationEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsElectric Stimulation TherapyAnalgesiaAnesthesia and Analgesia

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