NCT06611358

Brief Summary

Bruxism is the unconscious act of grinding or clenching the teeth. It leads to hyperactivity of the masticatory muscles due to non-functional mandibular movements, which can result in pain symptoms and is, therefore, a significant factor contributing to changes in the temporomandibular joint. While the beneficial effects of exercise and kinesio taping on temporomandibular dysfunction and bruxism have been validated by various studies in the literature, research investigating their impact on cervical awareness remains quite limited. Hence, the aim of this study is to examine the effects of kinesio taping in addition to exercise on pain, mandibular range of motion, sleep quality, depression levels, and cervical awareness in individuals with bruxism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2024

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

September 23, 2024

Last Update Submit

March 10, 2025

Conditions

Keywords

kinesiology tapingBruxismexercisetemporamandibular disfunction

Outcome Measures

Primary Outcomes (5)

  • Range of Motion

    Maximum mouth opening, protrusion, and lateral movements are jaw motions. Maximum mouth opening is determined by asking the patient to open their mouth as wide as possible and measuring the distance between the maxillary and mandibular incisors.

    From enrollment to the end of treatment at 2 weeks

  • Pittsburgh Sleep Quality Index

    The Pittsburgh Sleep Quality Index (PSQI) is a self-reported screening and assessment test that provides detailed information on sleep quality, as well as the type and severity of sleep disturbances over the past month. The form consists of 24 questions, from which scores for seven components are obtained: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Of the 24 questions, 19 are self-reported questions. The final five questions, which are answered by the bed partner or roommate, are not included in the scoring and are used only for clinical information. The self-reported questions cover various factors related to sleep quality, including estimates of sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems. The 18 items included in the scoring are grouped into seven component scores. Some components are represented by a single item, while

    From enrollment to the end of treatment at 2 weeks

  • Beck Depression Inventory

    The Beck Depression Inventory (BDI) was developed by Beck, Rush, Shaw, and Emery in 1978 with the aim of measuring somatic, emotional, cognitive, and motivational symptoms commonly observed in depression. The BDI consists of 21 items, each of which has four response options. Each item is scored on a scale from 0 to 3. By summing these scores, a total depression score is obtained. The maximum possible score is 63, with a higher total score indicating a higher level or severity of depression.

    From enrollment to the end of treatment at 2 weeks

  • Joint Position Sense

    The Cervical Joint Position Error Test is used to evaluate cervicocephalic proprioception and neck position sense. This test assesses the ability of the individual to return their head to the original neutral position after maximal rotation in the transverse and sagittal planes. Various devices such as laser pointers, electromagnetic devices, ultrasound-based devices, and electrogoniometers can be used to measure joint position sense error. Among these, using a laser pointer is more practical and easier compared to other methods and is frequently used.

    From enrollment to the end of treatment at 2 weeks

  • Visual Analogue Scale

    The Visual Analog Scale (VAS) consists of a pain level marked by the individual on a plane with a vertical line indicating the pain they are currently experiencing. The pain is rated as 0: no pain at all to 10: the most severe pain imaginable; Scoring is based on measuring the vertical mark made by the participant on the plane using a ruler.

    From enrollment to the end of treatment at 2 weeks

Study Arms (2)

Kinesiology Taping Group

EXPERIMENTAL

Individuals meeting the inclusion criteria will have kinesio tape applied to the temporomandibular joint by a physiotherapist every three days for a duration of two weeks. In addition to the kinesio taping, participants will perform an at-home exercise program prescribed three days a week. This program will include isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). As part of the treatment protocol, each movement will be performed in 3 sets of 15 repetitions.

Other: Kinesiology Taping and Exercise

Conventional Group

ACTIVE COMPARATOR

Individuals meeting the inclusion criteria will not receive kinesio taping but will follow the same exercise protocol as the Kinesio Taping + Exercise Group. Participants will perform an exercise program prescribed three days a week, including isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). As part of the treatment protocol, each movement will be performed in 3 sets of 15 repetitions.

Other: Convansionel Exercise

Interventions

Individuals meeting the inclusion criteria will receive kinesio taping applied to the temporomandibular joint by a physiotherapist every three days for two weeks. The kinesio tape will be applied along the origin-insertion line with zero tension. In addition to the kinesio taping, participants will follow a exercise program prescribed three days a week. This program will include isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). Each movement will be performed as 3 sets of 15 repetitions as part of the treatment protocol

Kinesiology Taping Group

This program will include isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). Each movement will be performed as 3 sets of 15 repetitions as part of the treatment protocol.

Conventional Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of teeth clenching complaints
  • Being between the ages of 20 and 50
  • No history of major trauma to the Temporamandibular region
  • No history of surgical operations on the temporomandibular joint

You may not qualify if:

  • Individuals with conditions that can cause facial pain, such as sinusitis or trigeminal neuralgia
  • Individuals with temporomandibular joint involvement secondary to inflammatory diseases
  • Individuals with degenerative problems that restrict neck movements
  • Individuals who have received treatment for bruxism in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Istanbul Medipol University

Istanbul, 34820, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BruxismMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 24, 2024

Study Start

August 26, 2023

Primary Completion

November 29, 2024

Study Completion

November 29, 2024

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations