NCT03499665

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 .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 7, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

April 9, 2018

Last Update Submit

April 9, 2018

Conditions

Keywords

BruxismPainExercisesMyofascialReleasing

Outcome Measures

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.

    6 weeks

Secondary Outcomes (1)

  • Change from restriction of jaw movement (The Jaw Functional Limitation Scale ) of patients with bruxism at 6 weeks.

    6 weeks

Other Outcomes (1)

  • Change from bad oral habits(The Oral Behaviour Checklist) of patients with bruxism at 6 weeks.

    6 weeks

Study Arms (3)

PNF, Myofascial Releasing Maneuvers, Home Exercise Group

EXPERIMENTAL

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

Myofascial Releasing Maneuvers and Home Exercises Group

ACTIVE COMPARATOR

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

Control Group

ACTIVE COMPARATOR

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

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.

PNF, Myofascial Releasing Maneuvers, Home Exercise 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.

Myofascial Releasing Maneuvers and Home Exercises Group
Control GroupBEHAVIORAL

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

Control Group

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, 44100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityBruxismPain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

BehaviorTooth DiseasesStomatognathic DiseasesHabitsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants didn't know taking which exercise treatment methods
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental, Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 9, 2018

First Posted

April 17, 2018

Study Start

June 7, 2017

Primary Completion

February 4, 2018

Study Completion

March 2, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations