NCT07028151

Brief Summary

Bruxism, defined as the involuntary clenching or grinding of teeth during sleep or wakefulness, is a common condition with multifactorial etiology. It can lead to various complications including temporomandibular joint (TMJ) pain, masticatory muscle hypertrophy, dental wear, headaches, and postural dysfunction. Although its underlying causes remain unclear, stress, poor sleep quality, postural problems, and excessive smartphone use have been identified as potential contributing factors. Recent studies suggest a significant relationship between bruxism and psychological as well as behavioral variables such as stress levels, screen time, and physical inactivity. University students, due to academic pressure and lifestyle habits, may be particularly vulnerable. This study aims to investigate the relationship between bruxism and smartphone addiction, sleep quality, and perceived stress among associate degree students at Bartın University. By identifying these associations, the study seeks to contribute to preventive strategies and promote awareness of bruxism-related risk factors in young adults.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

April 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 10, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

BruxismPhysical TherapyMassageTENSUltrasoundPain

Outcome Measures

Primary Outcomes (2)

  • Pain Level

    A visual analog scale (VAS) will be used to assess the severity of pain associated with bruxism. The patient will be asked to mark the severity of pain perceived at rest, during active use, and at night on a 10 cm long horizontal line with the words "0 (no pain)" at the beginning and "10 (most intense pain)" at the end. The individual's pain severity will be recorded by measuring the distance marked on the line in millimeters.

    From baseline to the end of treatment at 10 days

  • Pressure pain threshold

    Pressure pain threshold measurement will be used for digital algometer (Lafayette Manual Muscle Test System ™, Model 01163, Lafayette Instrument Company, Lafayette, In, USA). Before the measurement, all individuals will be informed about the test. During the measurement, individuals will be asked to sit in a comfortable and neutral position in a comfortable and neutral position to come into contact with the soles of the foot. Masseter and temporalis anterior's most swollen, upper trapeze is painful nervous point. The pressure will be applied with a disk head of 1 cm² and the power unit will be set to kg/cm². Values will be recorded by telling the patient to give a "stop" command as soon as he first feels the pain. The averages will be taken twice from the same point.

    From baseline to the end of treatment at 10 days

Secondary Outcomes (4)

  • Range of motion

    From baseline to the end of treatment at 10 days

  • The Depression-Anxiety-Stress Scale (DAS)

    From baseline to the end of treatment at 10 days

  • Insomnia Severity Index (ISI)

    From baseline to the end of treatment at 10 days

  • Bruxism

    From baseline to the end of treatment at 10 days

Study Arms (2)

Manual Therapy

EXPERIMENTAL

Participants who meet the inclusion criteria will be evaluated after providing written informed consent and will receive 10 sessions of approximately 40 minutes of classical face and neck massage

Other: manual therapy

Conventional Therapy

EXPERIMENTAL

Participants who meet the inclusion criteria will be evaluated after providing written informed consent and will commence the treatment sessions. Each session will consist of sequential applications of infrared therapy, ultrasound, and transcutaneous electrical nerve stimulation (TENS). The sessions, lasting approximately 40 minutes each, will be conducted over a total of 10 days

Other: Conventional Therapy

Interventions

Participants who meet the inclusion criteria will be evaluated following the acquisition of written informed consent. Treatment will be administered with participants in the supine position. Initially, soft tissue mobilization will be applied to the cervical extensor muscle group, followed by gentle cervical vertebral traction. Subsequently, a classical facial massage will be performed. The massage will include the suprahyoid muscles and the medial pterygoid. Intramuscular stretching and friction massage techniques will be applied to the masseter and anterior temporalis muscles. Each session will last approximately 40 minutes and will be conducted over a total of 10 sessions."

Manual Therapy

Participants who meet the inclusion criteria will be evaluated after providing written informed consent. Treatment will be administered with participants in the supine position. Protective goggles will be placed on the participants' eyes prior to the infrared therapy application. Following 20 minutes of infrared treatment, ultrasound (1 MHz) will be applied to the masseter muscle using the full-contact method for 3 minutes. Finally, transcutaneous electrical nerve stimulation (TENS) will be applied to the masseter and anterior temporalis muscles for 15 to 20 minutes. Each session will last approximately 40 minutes and will be conducted over a total of 10 sessions.

Conventional Therapy

Eligibility Criteria

Age18 Years - 27 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteer students aged between 18-27
  • Having at least two clinical signs of bruxism Abnormal tooth wear on the occlusal surfaces of the teeth Abfraction Gingival recession and/or cervical defect Tongue indentations or damage to the inside of the cheek Tense facial and jaw muscles, muscle sensitivity, and masseteric hypertrophy upon bidigital palpation

You may not qualify if:

  • Characterized by a neurological disease,
  • Botulinum toxin injections into the masticatory muscles in the last year,
  • Using antidepressant-type medications that will affect the central nervous system,
  • Receiving occlusal splint treatment,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University, Health Services Vocational School

Bartın, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BruxismPain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
To ensure blinding, baseline and final outcome measurements were performed by researchers other than the physiotherapist performing manual therapy and Conventional Treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Thirty patients with bruxism were randomly divided into as Manual Therapy Group (15) and Conventional Treatment Group (15).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 19, 2025

Study Start

April 1, 2024

Primary Completion

June 4, 2025

Study Completion

September 1, 2025

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

We can share the questionnaires and indexes used in the study

Shared Documents
STUDY PROTOCOL

Locations