Bruxism and Severity of Temporomandibular Dsyfunction

September 28, 2023 updated by: Hazel Çelik Güzel, Bandırma Onyedi Eylül University

The Effect of Bruxism on Masticatory Functionality and Severity of Temporomandibular Dsyfunction: A Cross-sectional Study

The aim of the study was to investigate the effect of bruxism on Temporomanbular joint functionality and dysfunction severity in individuals with Temporomandibular Dysfunction (TMD).

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

The study included 91 individuals aged 20-55 years with TMD. Participants who volunteered to participate in the study signed the Informed Consent Form and completed the Descriptive Data Form including demographic characteristics. The presence of bruxism in individuals with TMD was questioned and the maximum mouth opening measurement was recorded. TMD severity was assessed by Fonseca's Anamnestic Questionnaire (FAQ), pain severity was assessed by Numeric Pain Scale (NPS), and masticatory and TMJ functioning was assessed by JAW Functional Limitation Scale-20 (JFLS-20). The evaluations of the participants were performed only once.

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.
Observational

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.
91

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
      • Balıkesir, Turkey
        • Bandirma Onyedi Eylül 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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

diagnosed with TMD

Description

Inclusion Criteria:

  • Aged between 20 and 55 years,
  • Diagnosed with TMD,
  • volunteer to participate in the study

Exclusion Criteria:

  • having a non-reduced disc problem,
  • surgical operation due to spine, abdomen and/or TMJ problem,
  • trauma, cancer, neurological problems, congenital anomalies, musculoskeletal system problems,
  • systemic disease,
  • facial paralysis
  • Less than 6 months of receiving any treatment related to the spine and TMJ

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

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
Bruxism evaluation
Time Frame: April 2023- September 2023
Sleep bruxism reported by the individual was recorded. As clinical diagnostic criteria for bruxism; the presence of regular or frequent teeth clenching and grinding sounds followed by pain or fatigue in the jaw muscles on waking up in the morning, temporal headache, masseter muscle hypertrophy, abnormal tooth abrasion and/or jaw locking were questioned and the presence of one or more clinical findings was recorded as bruxism.
April 2023- September 2023
Maximum mouth opening
Time Frame: April 2023- September 2023
Maximum pain-free mouth opening was measured with a 15 cm ruler
April 2023- September 2023
Severity of Temporomandibular dysfunction
Time Frame: April 2023- September 2023
Fonseca's Anamnestic Questionnaire (FAQ) was used. The questionnaire includes 10 questions about joint, head and neck pain, pain during masticatory activity, parafunctional habits, decreased joint motion, impaired occlusion and emotional stress. As a result of the questionnaire, the presence of TMD is accepted in patients with a score of 25 and above, and the severity can be classified as mild TMJ disorder (25-45), moderate TMJ disorder (50-65) and severe TMJ disorder (70-100).
April 2023- September 2023
Pain intensity
Time Frame: April 2023- September 2023
Numeric Pain Scale (NAS): It is a simple, reliable and short-term method commonly used in the clinic to measure pain intensity. The patient is told that the most severe pain he/she feels in the TMJ region is 10, and if there is no pain, the pain intensity is 0. The participant was asked to say a number between 0 and 10 corresponding to the intensity of pain felt in the TMJ region.
April 2023- September 2023
Jaw Functionality
Time Frame: April 2023- September 2023
Jaw Functionality Limitation Scale-20 was used. It includes a total of 20 items, with "0" indicating no limitation and "10" indicating severe limitation in each item, about the function of the TMJ during different activities, difficulty in chewing and jaw limitation. As a result of the questionnaire, it was reported that TMJ function was limited in individuals with a score of 5 and above.
April 2023- September 2023

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.
Bandırma Onyedi Eylül 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.
April 15, 2023

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.
September 1, 2023

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.
September 15, 2023

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).
September 19, 2023

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.
September 19, 2023

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.
September 26, 2023

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.
September 29, 2023

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.
September 28, 2023

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.
September 1, 2023

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.
  • 2023-54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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