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The Effects of Proprioceptive Neuromuscular Facilitation, Myofascial Releasing Maneuvers and Home Exercises on Pain and Jaw Function in Patients With Bruxism

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ClinicalTrials.gov Identifier: NCT03499665
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Elisa Çalışgan, İnonu University

Brief Summary:
This study was planned to evaluate the effects of proprioceptive neuromuscular facilitation, myofascial releasing maneuvers and home exercises on pain and jaw function in patients with bruxism aged 16-50 years .

Condition or disease Intervention/treatment Phase
Exercise Bruxism Myofascial Behavioral: PNF, Myofascial Releasing Maneuvers, Home Exercise Group Behavioral: Myofascial Releasing Maneuvers and Home Exercises Group Behavioral: Control Group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental, Randomized Controlled Study
Masking: Single (Participant)
Masking Description: Participants didn't know taking which exercise treatment methods
Primary Purpose: Treatment
Official Title: Assessment The Effects of Proprioceptive Neuromuscular Facilitation, Myofascial Releasing Maneuvers and Home Exercises on Pain and Jaw Function in Patients With Bruxism
Actual Study Start Date : June 7, 2017
Actual Primary Completion Date : February 4, 2018
Actual Study Completion Date : March 2, 2018

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Arm Intervention/treatment
Experimental: PNF, Myofascial Releasing Maneuvers, Home Exercise Group
This group of patients received patients with bruxism. It was applied proprioceptive neuromuscular facilitation (PNF), myofascial releasing maneuvers and home exercises.
Behavioral: PNF, Myofascial Releasing Maneuvers, Home Exercise Group
For Group 1 (n:20), the PNF, myofascial releasing and home exercises were used to decrease pain, jaw restriction and improve functional mobility on the masseter, lateral and medial pterygoid, buccinator, temporalis, orbicularis oris, orbicularis oculi, upper side of trapezius muscle, splenius, scalenous, and cervical extensor muscle in 20 patients with bruxism, for 2 and 6 weeks after pre-evaluation. PNF, myofascial releasing and home exercises were administered for 2 weeks, followed by 3 sets of 10 repeat home exercises and 6 weeks under physiotherapist control.

Active Comparator: Myofascial Releasing Maneuvers and Home Exercises Group
This group of patients received patient with bruxism. It was applied myofascial releasing maneuvers and home exercises.
Behavioral: Myofascial Releasing Maneuvers and Home Exercises Group
In Group 2 (n:15), as myofascial releasing and home exercise group,final evaluation was made with 10 sets of myofascial releasing and home exercises for 2 and 6 weeks.

Active Comparator: Control Group
This group of patients received patient with bruxism. It was applied conventional treatment and no myofascial releasing or Proprioceptive Neuromuscular Facilitation exercises were applied.
Behavioral: Control Group
In Group 3 (n:17), as the control group, no myofascial releasing or Proprioceptive Neuromuscular Facilitation exercises were applied.




Primary Outcome Measures :
  1. Change from pain (Visual Analog (VAS) Scale ) of patients with bruxism at 6 weeks. [ Time Frame: 6 weeks ]
    The severity of pain was evaluated using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (intolerable pain).The VAS scale is recommended for evaluation because of highly reliability.


Secondary Outcome Measures :
  1. Change from restriction of jaw movement (The Jaw Functional Limitation Scale ) of patients with bruxism at 6 weeks. [ Time Frame: 6 weeks ]
    The Jaw Functional Limitation Scale is a scale assessing the restriction of jaw movement. It consists of 8 items related to normal daily functions of the mouth, such as chewing, yawning, swallowing and smiling, with each item scored on a scale of 0 (no restriction) to 10 (high restriction), thus total scores range from 0 -80 (8, 11).


Other Outcome Measures:
  1. Change from bad oral habits(The Oral Behaviour Checklist) of patients with bruxism at 6 weeks. [ Time Frame: 6 weeks ]
    The Oral Behaviour Checklist consists of 21 questions about bad oral habits. This scale is answered as a 5-point Likert scale with the responses of never, occasionally, sometimes, often, and always. The total points of the scale range from 0 to 84 .



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having bruxism and TMJ (Temporomandibular Joint) pain,
  • Bruxism patients aged 16-50 years
  • At the level that can make mental evaluations,
  • Will be able to adapt to the training program,
  • To be involved in voluntary work,
  • Individuals who have been given their informed consent

Exclusion Criteria:

Patients who are not between the ages of 16-50, who have a health problem, can not make mental evaluations, can not adapt to the education program, and refuse to participate in the study will not be included.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499665


Locations
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Turkey
Inonu University
Malatya, Turkey, 44100
Sponsors and Collaborators
İnonu University

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Responsible Party: Elisa Çalışgan, Research Assistant, İnonu University
ClinicalTrials.gov Identifier: NCT03499665     History of Changes
Other Study ID Numbers: 2017/98
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elisa Çalışgan, İnonu University:
Bruxism
Pain
Exercises
Myofascial
Releasing
Additional relevant MeSH terms:
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Bruxism
Tooth Diseases
Stomatognathic Diseases