ClinicalTrials.gg
CompletedNCT03499665Updated Apr 17, 2018

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

An interventional study of PNF, Myofascial Releasing Maneuvers, Home Exercise Group and Myofascial Releasing Maneuvers and Home Exercises Group in Exercise, Bruxism and Myofascial, sponsored by Inonu University. Completed at 1 site in Turkey. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-04-17.

Primary conditionBruxismRegistry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Bruxism
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Bruxism.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Inonu University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2017, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
16 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 66 studies in Bruxism with a site in Turkey — 11 open to participants now, 13 under way, none of them phase 3. Bruxism · Turkey.

Enrollment
11th of 41
52 · median 36
Started
2017
the only one that year
No phase
39 of 66
5 open now
Registered
1st of 66
by date
Lead sponsor
2 of 66
Inonu University

Among the 66 studies in Bruxism with a site in Turkey, this one is the 11th largest by enrollment of the 41 interventional ones, is the only one that started in 2017, is one of 39 with no phase, and was the 1st registered.

By phase

66 studies; the count open now beside each. This study's row is marked.

No phasethis study39 · 5 open
Observational25 · 4 open
Phase 11 · 1 open
Phase 41 · 1 open

By the year they started

First in 2017; this study’s year is marked. 1 started in 2017.

Size and results

Median enrollment 36 across the 41 interventional studies, 76 across the 25 observational. Of the 52 that completed or were terminated, 2 (4%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 66 studies in Bruxism with a site in Turkey, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Exercise
  • Bruxism
  • Myofascial

Browse trials for

Keywords

  • Bruxism
  • Pain
  • Exercises
  • Myofascial
  • Releasing
04

In context

Bruxism Reclassified

151 studies on the registry are indexed under Bruxism; 39 are open to participants now.

This study's enrollment of 52 is above the median of 39 across 94 interventional studies indexed under Bruxism.

Browse Bruxism studies →

Lead sponsor

Inonu University is the lead sponsor of 394 studies on the registry; 95 are open to participants now.

Compared within Bruxism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
52 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • BehavioralPNF, 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.

  • BehavioralMyofascial 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.

  • BehavioralControl Group

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

07

What researchers measure

Primary outcomes

  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.

    Time frame: 6 weeks

Secondary outcomes

  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).

    Time frame: 6 weeks

Other outcomes

  1. Change from bad oral habits(The Oral Behaviour Checklist) of patients with bruxism at 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 .

    Time frame: 6 weeks

08

Study locations

1 site
  • Inonu University
    Malatya, 44100, Turkey
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Feb 2018, 7 months.

Of 59 non-industry interventional studies with no phase under Bruxism, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's 7 months is below that.

Counting every sponsor, half of 60 studies reached it within 7 months; a quarter within 3 and three quarters within 13.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2018
First posted
Apr 17, 2018
StartActual
Jun 7, 2017
Primary completionActual
Feb 4, 2018
CompletionActual
Mar 2, 2018
Last update
Apr 17, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03499665
Lead sponsor
Inonu University
Responsible party
Elisa Çalışgan (Research Assistant, Inonu University) — Principal investigator
First posted
Apr 17, 2018
Start date
Jun 7, 2017
Primary completion
Feb 4, 2018
Completion
Mar 2, 2018
Last update
Apr 17, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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