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ExerciseNCT03499665

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

A study testing PNF, Myofascial Releasing Maneuvers, Home Exercise Group and Myofascial Releasing Maneuvers and Home Exercises Group in people with Exercise and Bruxism, run by Inonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 16 to 50 years
Conditions the study is for
Exercise, Bruxism, Myofascial
What is being tested?
PNF, Myofascial Releasing Maneuvers, Home Exercise Group and Myofascial Releasing Maneuvers and Home Exercises Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Jun 2017to 2 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Inonu University

    Malatya, 44100

Other trials in Turkey (Türkiye)

About this study

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

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 .

Read the detailed description

Bruxism is different from temporomandibular joint disease because of long periods of muscle contraction. It is considered an eloquent contributory factor in the etiology of temporomandibular disorders (TMD). The incidence of bruxism is estimated to be approximately between 5% and 10% of the adult population. Especially long term contraction of masseter, temporalis and medial pterygoid muscle cause restriction of opening mouth, problem of closing the jaw, problems of chewing, articulation, movement of tongue. Bruxism is common illness which is seen with in mood disorders such as anxiety and depression. According to Orofacial Pain Guidelines, Bruxism is a diurnal or nocturnal parafunctional activity including clenching, bracing, grinding and gnashing of the teeth. An oral habit consisting of involuntary rhythmic or spasmodic nonfunctional horizontally and vertically gnashing, grinding or clenching of teeth, in other than chewing movements of the mandible, this may bring about occlusal trauma.

The factors involving anatomical- morphological, psychophysiological, pathophysiological factors and other cause diurnal or nocturnal bruxism. Researchers say that genetics account for 30 to 50 percent of bruxism with nocturnal or diurnal and behaviour, environmental account for the remainder. Dental malocclusion, anatomical- morphological differences, anomalies of the oro-facial region (condyles height asymmetry, hypognathism, larger cranial, bizygomatic width, rectangular form of dental arch of maxilla, rectangular morphology of face) psychophysiological reasons including stress in which result from emotional, physical, psychosocial stimulation, anxiety, depression, psychosomatic disorders, personality disorders such as hyperactivity, hysteria, aggressiveness, tendency of perfectionist affect oral function and cause bruxism . Sleep disturbances known as especially sleep apnea, behaviour disorder during REM ( rapid eye movement) and Non-REM (non- rapid eye movement) sleep stimulate of nocturnal bruxism. Consume of drug such as antidepressants (SSRI) have suppression and stimulate effects on patients seen. Vulnerable disorders of central dopaminergic neurotransmission, hemifacial spasm, stroke brain haemorrhage, Huntington chorea, Parkinson disease give rise to bruxism. While the acute use of L- dopa drugs inhibits bruxism activity, the chronic use of L- dopa in patients with Parkinson lead to bruxism. This situation is same effect with antiepileptic drugs. According to some criteria bruxism may be categorized by when it appears awake bruxism which is presented when the person is awake, sleep bruxism which is presented when the person is sleep and combined bruxism which is presented when seen two situations . By etiology researcher classified with primary or idiopathic bruxism which no apparent cause is known. Secondary bruxism occurs with diseases (coma, ictus, cerebral palsy), medicinal products (e.g. antipsychotic medication), drugs (such as amphetamines, ecstasy). Bruxism classified motor activity type of tonic, phasic, combined and by current or past presence such as past bruxism, current or present bruxism. Sleep bruxism major seen during REM and Non- REM sleep and is the most common type of bruxism than others. Its incidence has been the highest in childhood (vitally 14%) and decreases from about 8% in younger adults to almost 3% in elderly people called negative correlation . In awake bruxism is an involuntary activity of the jaw muscles that is characterized, by jaw clenching, by tooth gnashing and/or grinding. During sleep bruxism, both clenching and tooth grinding are observed. Sleep bruxism can lead to tooth destruction, temporomandibular pain and crepitation, headaches and grinding sounds . A lot of patients are complain of jaw tightness and grinding sounds daily or nightly, while others said these infrequently. In cases of severe and frequent sleep bruxism, the variation of the number of episodes per hour of sleep is 25%, and the variation of tooth-grinding frequency is 53.5%. Symptoms of bruxism are abnormal tooth wear, teeth gliding or clenching, sounds because of clenching and gliding, gingival inflammation, headache, ocular pain, limited opening of mouth, decrease of salivary flow, erythema, photosensitivity, tinnitus, ear plugging sensation, temporomandibular pain (TMP), destruction and click sounds. When overtime in patients have chronic bruxism will bring about hypertrophy of masseter and temporal muscles. Therefore, patients facial appearance seems either too square or too masculine. One of the general symptoms are jaw clicking, when opening of mouth; oral muscle deviation to one side, pain in cheek muscles, uncontrollable movement of jaw. Effects of bruxism on throat are swallowing difficulties, voice irregularities, frequence coughing, feeling of foreign things in throat. In addition it causes neck problems such as pain of the shoulders and ache of back, lack of mobility, stiffness, pain of neck. Facial changing are seen patients with bruxism skin and facial muscles atrophy due to not using, vermilion thighs, dropping corners of mouth., Treatment of bruxism includes botulinum toxin, using occlusal splint, perioral rejuvenation and an antidepressant drugs. Our study shows that self-care, Proprioceptive neuromuscular facilitation exercise, myofascial thingness and home exercise including facial muscle stimulation for weight transform between bilateral side. Mainly self-care is more important than others. Therefore, we informed patients about causes, etiology, triggered effects, prevalence, incidence of bruxism, normal treatment of bruxism and our treatment stages and goals. It includes that patients are aware of bruxism. When the patients who have bruxism diagnosis, feel pain on face muscle, they need to use ice on jaw muscle. In addition they avoid eating rigid, hard stick, candy and nuts. Also, they avoid chewing gum and elastic rating, avert jaw movement forward. They should sleep the least 8 hours and need to learn stretching exercise to restore of the facial muscle and joints. In addition flexibility and stretching training of orbicularis oris and oculi, extensor muscle stabilization exercises are used for bruxism treatment. Main purpose of this study is to evaluate of the effects of proprioceptive neuromuscular facilitation , myofascial releasing maneuvers and home exercises on temporomandibular joint pain and jaw function in patients with bruxism.

Being tested
PNF, Myofascial Releasing Maneuvers, Home Exercise Group, Myofascial Releasing Maneuvers and Home Exercises Group, Control Group
Keywords
Bruxism, Pain, Exercises, Myofascial, Releasing
Medical subject headings
Motor Activity, Bruxism, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PNF, Myofascial Releasing Maneuvers, Home Exercise GroupBehavioural

    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.

  • Myofascial Releasing Maneuvers and Home Exercises GroupBehavioural

    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.

  • Control GroupBehavioural

    In Group 3 (n:17), as the control group, no myofascial releasing or Proprioceptive Neuromuscular Facilitation exercises were applied.

Study groups in NCT03499665
Study groupRoleWhat they receive
PNF, Myofascial Releasing Maneuvers, Home Exercise GroupExperimentalThis group of patients received patients with bruxism. It was applied proprioceptive neuromuscular facilitation (PNF), myofascial releasing maneuvers and home exercises.
Receives: Behavioral: PNF, Myofascial Releasing Maneuvers, Home Exercise Group
Myofascial Releasing Maneuvers and Home Exercises GroupActive comparatorThis group of patients received patient with bruxism. It was applied myofascial releasing maneuvers and home exercises.
Receives: Behavioral: Myofascial Releasing Maneuvers and Home Exercises Group
Control GroupActive comparatorThis group of patients received patient with bruxism. It was applied conventional treatment and no myofascial releasing or Proprioceptive Neuromuscular Facilitation exercises were applied.
Receives: Behavioral: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from pain (Visual Analog (VAS) Scale ) of patients with bruxism at 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.

    Measured: 6 weeks

Secondary outcomes (1)
  1. Change from restriction of jaw movement (The Jaw Functional Limitation Scale ) of patients with bruxism at 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).

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2018
  2. Study start7 Jun 2017
  3. Primary completion4 Feb 2018
  4. Study completion2 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental, Randomized Controlled Study
Masking
Single blind
Who is masked
Participant
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03499665
Sponsor's protocol ID
2017/98
Status last verified
Apr 2018
First submitted
9 Apr 2018
Last updated
17 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PNF, Myofascial Releasing Maneuvers, Home Exercise Group and Myofascial Releasing Maneuvers and Home Exercises Group in people with Exercise and Bruxism, run by Inonu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from pain (Visual Analog (VAS) Scale ) of patients with bruxism at 6 weeks. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.

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