Investigation of the Effects of Kinesio Taping and Manual Therapy in Patients With Bruxism

April 24, 2020 updated by: Gokhan Yazici, Gazi University
Bruxism is defined as a repetitive jaw-muscle activity characterized by tooth grinding or clenching accompanied with wearing of the teeth, and jaw muscle discomfort in the absence of a medical disorder . Bruxism has two distinct circadian manifestations: it can be nocturnal or diurnal. Hypertrophy of the masseter muscle is an objective sign of bruxism. Additionally, fatigue or stiffness in the masticatory muscles, pain in the temporomandibular joint or headaches are subjective signs of bruxism. According to literature, 85% to 90% of the general population experience episodes of bruxism during their lives. Thus, finding an effective treatment method for bruxism is crucial.The aim of this study is to investigate the effects of two different physiotherapy approaches on the masseter muscle thickness and stiffness in patients with Bruxism.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There is no certain treatment for Bruxism. However, the most recent recommendation is to follow the Multiple-P approach prior to medical drug regimens and invasive procedures. Different methods used in the conservative management of Bruxism are known as the "multiple-P" approach, which consists of; physiotherapy, plates, pep talk, pills and psychology . Physiotherapy generally focuses on two objectives: decreasing the adverse effects of bruxism to the masticatory muscles and increasing self-awareness regarding this habit. These studies involve different intervention such as massage of the masticatory and cervical muscles, electrotherapy, therapeutic exercises, taping interventions or relaxation therapies . However, literature regarding which physiotherapy intervention is the most effective in bruxism is not clear. Therefore patients in this study were randomly divided into one of two groups; manual therapy or kinesio taping. All patients were assessed at baseline, received 4 weeks of treatment and were assessed following the 4 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06650
        • Gazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A Bruxism Diagnosis according to the criteria of the international classification for sleep disorders
  • Self-report of awake bruxism

Exclusion Criteria:

  • Having more than 2 missing teeth
  • The presence of removable partial dentures
  • Having neurological, psychiatric or motor disorders
  • Having any ongoing dental or physical therapy
  • Active cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Manual Therapy
Manual Therapy is a widely used physiotherapy modality which is known to be effective in the management of musculoskeletal problems . Manual Therapy is a passive, therapeutic approach used to target a variety of anatomical structures with the intent to create beneficial changes in the amount of pain a patient experiences. Manual Therapy includes joint mobilization, manipulation, or treatment of the soft tissues and is widely used to break fibrous adhesions, restore normal range of motion, reduce local ischemia, stimulate synovial fluid production, and reduce pain .
Procedure: Manual Therapy
Participants in this group received 4 weeks of manual therapy and massage of the masticatory muscles intra and extra orally together with massage of the cervical muscles. Massage and Manual Therapy brings about benefits by increasing local circulation and decreasing muscle tonus . Additionally, stretching exercises aiming to decrease pain and elongate shortened masticatory muscle fibers by autogenic inhibition of the masseter muscle were performed.
Experimental: Kinesio Taping
Kinesio tape is a type of elastic therapeutic tape that was developed which is used in many different situations with various aims. Advocates of Kinesio Tape state that it may promote different therapeutic objectives such as; improved circulation and lymphatic drainage, pain inhibition, reduction of delayed onset of muscle soreness or improvement in performance and coordination .
Procedure: Kinesio Taping
Participants in this group had an application of Kinesio Taping on the masseter muscles. The material used for bruxism Kinesio Taping application was Kinesio Tex Gold Finger Prints (Kinesio Holding Corporation, Albuquerque, USA), a 100% cotton, latex-free, 5-cm wide, elastic tape. Kinesio Taping placement was chosen according to principles described by Kase et al. Tapes were cut 2.5 cm in width (cut in half vertically from 5 cm width). Two strips of Kinesio Tape were crossed over the masseter muscle area with 0-5% tension in maximum stretched epidermis position. Web-cut strips epidermis-dermis-fascia technique were used. Tape was applied bilaterally after every session of manual therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Pressure Threshold of Masseter Muscle
Time Frame: Change from Baseline Pain Pressure Threshold of Masseter Muscle at 4 weeks
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the masseter muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Change from Baseline Pain Pressure Threshold of Masseter Muscle at 4 weeks
Pain Pressure Threshold of Trapezius Muscle
Time Frame: Change from Baseline Pain Pressure Threshold of Trapezius Muscle at 4 weeks
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the trapezius muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Change from Baseline Pain Pressure Threshold of Trapezius Muscle at 4 weeks
Pain Pressure Threshold of Temporalis Muscle
Time Frame: Change from Baseline Pain Pressure Threshold of Temporalis Muscle at 4 weeks
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the temporalis muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Change from Baseline Pain Pressure Threshold of Temporalis Muscle at 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: Change from Baseline Sleep Quality at 4 weeks
The Pittsburgh Sleep Quality Index is an index widely used to measure sleep quality. The Pittsburgh Sleep Quality Index is a self-reported questionnaire that includes 19 questions that when scored, are separated into seven domains. The seven domains are; perceived sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medications; and daytime dysfunction. Each domain is scored from 0-3 and a total score ranging from 0-21 can be obtained. A total score of; 0-4 indicates a good sleep quality, 5-10 indicates poor sleep quality and scores above 10 indicate a possible sleep disorder.
Change from Baseline Sleep Quality at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gokhan Yazici, PhD, Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GaziU2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data (IPD) will not be available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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