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BruxismNCT06914388

Impact of Self-Management Strategies in Self-Reported Bruxism

A study testing Self-Management Strategies in people with Bruxism and Self-management, run by Cyprus International 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 aim to evaluate the effects of a 6-week self-management program on pain, muscle stiffness, and temporomandibular joint (TMJ) functions in sedentary individuals aged 18-40 with bruxism. Thirty-five individuals will be evaluated. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Bruxism, Self-management, Pain
What is being tested?
Self-Management Strategies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Jul 2024to 17 Feb 2025
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 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adults aged 18 to 40 years
  • Sedentary lifestyle
  • Clinical diagnosis of sleep and/or awake bruxism

Who cannot join

  • Significant musculoskeletal disorders of the cervical or thoracic spine
  • Chronic illnesses
  • Neurological conditions affecting balance and postural control
  • Pregnancy
  • The presence of dental prostheses
  • Participants who missed more than 15 sessions

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Turkey

    Mersin, Lefkosa, 99040

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Self-Management Strategies on Pain, Muscle Stiffness and Temporomandibular Joint Functions in Individuals With Bruxism

This study aim to evaluate the effects of a 6-week self-management program on pain, muscle stiffness, and temporomandibular joint (TMJ) functions in sedentary individuals aged 18-40 with bruxism. Thirty-five individuals will be evaluated. Bruxism will be assessed using the Bruxism Assessment Questionnaire, while temporomandibular joint dysfunction (TMJD) will be evaluated using the Helkimo Clinical Dysfunction Index and the Fonseca Questionnaire. Masseter muscle pain threshold will be measured with a digital algometer, muscle stiffness with a Shore Durometer, mandibular depression range of motion with a bicondylar caliper, and TMJ proprioception with TMJ position sense. Assessments will be conducted pre-intervention and at the end of the fourth week.

Read the detailed description

The 4-week self-management program significantly increased the masseter pain threshold (p<0.001) and reduced muscle stiffness at rest and during contraction (p<0.001). TMJD severity, as measured by the Helkimo Index (p=0.010) and Fonseca Questionnaire (p<0.001), was significantly reduced. Additionally, TMJ position sense and mandibular depression range of motion improved significantly (p<0.001). Self-management strategies positively impact bruxism symptoms, including pain, muscle stiffness, and TMJ functions. These strategies should be considered an integral part of TMJD and bruxism management.

Being tested
Self-Management Strategies
Keywords
Bruxism, Self-Management Strategies, Proprioception, Muscle Stiffness, Pain, Temporomandibular Joint Dysfunction
Medical subject headings
Bruxism, Pain, Temporomandibular Joint Disorders

What participants receive

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

  • Self-Management StrategiesOther

    Stretching exercises, strengthening exercises, massage, relaxing exercises, breathing exercises, patient education

Study groups in NCT06914388
Study groupRoleWhat they receive
Self-ManagementExperimentalParticipants were recruited from individuals seeking treatment at a physiotherapy clinic.
Receives: Other: Self-Management Strategies

What is being measured

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

  1. Bruxism Assessment

    Bruxism will be assessed using self-reports, which are considered appropriate for both clinical and research purposes. Awake bruxism will be diagnosed based on participants' self-awareness, determined by asking whether they had noticed clenching or grinding their teeth while awake in the past six months. Individuals who respond affirmatively will be classified as having awake bruxism. Sleep bruxism will be diagnosed using the 2014 criteria established by the American Academy of Sleep Medicine (AASM). Participants will be asked whether they frequently noticed teeth grinding during sleep, will be informed of it by others, or observed excessive tooth wear. Additionally, they will be questioned about symptoms upon waking, such as jaw fatigue, tension, or pain; sensations of clenching or pain in the mouth; temple pain; difficulty opening the mouth; tension in the jaw joint requiring movement to release; or clicking sounds in the jaw joint that disappear afterward.

    Measured: 8 weeks

  2. Temporomandibular Joint Dysfunction

    Temporomandibular Joint Disorder (TMJD) will be evaluated using the Helkimo Clinical Dysfunction Index (HCDI). This instrument is considered valid and reliable measures of TMJD. The scoring system categorises participants into four groups: no clinical symptoms (score 0), mild TMJD (scores 1-4), moderate TMJD (scores 5-9), and severe TMJD (scores 10-25)

    Measured: 8 weeks

  3. Temporomandibular Joint Dysfunction

    Temporomandibular Joint Disorder (TMJD) will be evaluated using the Fonseca Questionnaire. This instrument is considered valid and reliable measures of TMJD. Participants will be instructed to respond to each question as 'yes' (10 points), 'no' (0 points), or 'sometimes' (5 points). The questionnaire results will be classified as no TMJD (0-15), mild TMJD (20-40), moderate TMJD (45-65), and severe TMJD (70-100) based on the responses provided by the participants.

    Measured: 8 weeks

  4. Masseter Muscle Pain Threshold Measurement

    The pain threshold of the masseter muscle will be assessed bilaterally over the muscle belly using a JTECH Commander digital algometer. Three measurements will be taken from the muscle belly, and the average value will be calculated. Participants will be instructed to indicate the moment they first perceived pain, and the value will be display on the device will be recorded as the pain threshold in pounds. Higher scores indicate better pain threshold.

    Measured: 8 weeks

  5. Masseter Muscle Stiffness

    The stiffness of the masseter muscle will be assessed using a Shore Durometer OO (M\&A Instruments Inc., United States), a handheld device designed for convenient and non-invasive measurement of muscle stiffness. The durometer evaluates tissue properties by measuring oscillations generated through mechanical contact with the assessed muscle. Measurements will be performed bilaterally over the belly of the masseter muscle during both resting and maximum contraction states. Each measurement will be repeated three times, and the average values will be recorded in Newtons per meter.

    Measured: 8 weeks

Secondary outcomes (2)

  1. Temporomandibular Joint Position Sense

    The measurement of TMJPS will be conducted using 9 test sticks ranging from 4 mm to 8 mm in thickness, with 0.5 mm increments. A 6 mm thick wooden bar will be used as a reference. Participants first bit the 6 mm reference stick with their front teeth for 1 minute to familiarize themselves with the reference thickness. Subsequently, they will be asked to bite each of the 9 test sticks in a random order and compare their thickness to the reference stick. Each test stick will be presented 5 times, resulting in a total of 45 tests. Participants will indicate whether the test stick felt "thinner," "thicker," or "equal" compared to the reference stick. During the test, participants' eyes will be closed, and their responses will be recorded as correct (1 point) or incorrect (0 points). Total scores will be calculated for analysis.

    Measured: 8 weeks

  2. Mandibular Depression Range of Motion

    The range of motion for mandibular depression will be assessed by evaluating the maximum mouth opening. Participants will be instructed to open their mouths as wide as possible. The distance between the lower and upper central incisors will be measured using a bicondylar caliper (Holtain Ltd., UK) and will be recorded in centimeters (cm). Each measurement will be repeated three times, and the average value will be calculated.

    Measured: 8 weeks

Timeline

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

  1. First posted6 Apr 2025
  2. Study start3 Jul 2024
  3. Primary completion20 Aug 2024
  4. Study completion17 Feb 2025

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
Not applicable
Intervention model
Single group
Model description
Interventional Study
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06914388
Sponsor's protocol ID
020-5790
Status last verified
Mar 2025
First submitted
28 Mar 2025
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mesko ME, Hutton B, Skupien JA, Sarkis-Onofre R, Moher D, Pereira-Cenci T. Therapies for bruxism: a systematic review and network meta-analysis (protocol). Syst Rev. 2017 Jan 13;6(1):4. doi: 10.1186/s13643-016-0397-z.

    PubMed 28086992

  • Micoogullari M, Yuksel I, Angin S. Efficacy of scapulothoracic exercises on proprioception and postural stability in cranio-cervico-mandibular malalignment: A randomized, double-blind, controlled trial. J Back Musculoskelet Rehabil. 2024;37(4):883-896. doi: 10.3233/BMR-230323.

    PubMed 38427467

  • Winocur E, Uziel N, Lisha T, Goldsmith C, Eli I. Self-reported bruxism - associations with perceived stress, motivation for control, dental anxiety and gagging. J Oral Rehabil. 2011 Jan;38(1):3-11. doi: 10.1111/j.1365-2842.2010.02118.x.

    PubMed 20557433

  • Koyano K, Tsukiyama Y, Ichiki R, Kuwata T. Assessment of bruxism in the clinic. J Oral Rehabil. 2008 Jul;35(7):495-508. doi: 10.1111/j.1365-2842.2008.01880.x.

    PubMed 18557916

  • Manfredini D, Bucci MB, Sabattini VB, Lobbezoo F. Bruxism: overview of current knowledge and suggestions for dental implants planning. Cranio. 2011 Oct;29(4):304-12. doi: 10.1179/crn.2011.045.

    PubMed 22128671

  • Feu D, Catharino F, Quintao CC, Almeida MA. A systematic review of etiological and risk factors associated with bruxism. J Orthod. 2013 Jun;40(2):163-71. doi: 10.1179/1465313312Y.0000000021.

    PubMed 23794697

Questions about this trial

What is this clinical trial studying?

A study testing Self-Management Strategies in people with Bruxism and Self-management, run by Cyprus International 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 3 inclusion and 6 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 6 Apr 2025. 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?

Bruxism Assessment (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06914388, which also lists 6 linked publications.

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 6 Apr 2025.

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