NCT07058311

Brief Summary

Bruxism is a multifactorial condition that affects the masticatory muscles and often requires multidisciplinary management. This study aimed to investigate and compare the effects of manual therapy and home exercise on pain intensity, number of myofascial trigger points, temporomandibular joint (TMJ) and cervical mobility, head posture, muscle thickness, stiffness, and activity in individuals with bruxism. Methods: Thirty individuals diagnosed with bruxism were randomly assigned to two intervention groups: the Home Exercise Group (HEG) and the Manual Therapy Group (MTG). All participants received education about bruxism. The HEG performed a supervised home-based exercise program three times per week for eight weeks, supported by instructional videos and weekly follow-up. The MTG received intraoral and extraoral manual therapy targeting the jaw and cervical regions twice a week over the same period. Pain intensity (Visual Analog Scale), trigger point count (palpation), TMJ mobility (ruler), head posture and cervical mobility (goniometer), muscle thickness and stiffness (ultrasound), and muscle activity (electromyography) were evaluated before and after treatment.

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 Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

May 9, 2025

Last Update Submit

September 3, 2025

Conditions

Keywords

BruxismManual TherapyExerciseUltrasonographyElectromyographyphysiotherapy

Outcome Measures

Primary Outcomes (4)

  • Pain Level

    Visual analog scale (VAS) was used to assess the severity of pain related to bruxism. On a 10 cm long horizontal line, "0 (no pain)" was written at the beginning and "10 (most intense pain)" was written at the end and the patient was asked to mark the pain intensity they perceived at rest, active use and at night on the line. The pain intensity of the individual was recorded by measuring the distance marked on the line in millimeters. It has been reported that the Turkish version of the VAS is a valid and reliable measurement tool in the evaluation of musculoskeletal disorders

    From baseline to the end of treatment at 8 weeks

  • Cervical and Temporomandibular Joint Range of Motion (ROM)

    Cervical flexion, extension, lateral flexion, and rotation were measured using a universal goniometer. TMJ range of motion, including maximum mouth opening, protrusion, retrusion, and lateral excursions, was measured using a ruler.

    From baseline to the end of the treatment at 8 weeks

  • Ultrasonographic Imaging

    Ultrasound and elastography measurements were performed using the ACUSON S 2000 system (Siemens, Munich, Germany) by a single experienced radiologist. A 4-9 MHz linear transducer was used to measure the thickness and elasticity of the masseter, anterior temporalis, and SCM muscles both at rest and during maximal clenching, in a semi-recumbent position with head support. Measurements were recorded in millimeters

    From baseline to the end of treatment at 8 weeks

  • Electromyography (EMG)

    Surface EMG recordings were obtained using an 8-channel EMG system (BioResearch Inc., Milwaukee, Wisconsin, USA). Self-adhesive disposable surface electrodes were placed bilaterally over the masseter, anterior temporalis, and SCM muscles, with a grounding electrode on the trapezius. Electrodes were aligned parallel to muscle fibers at the muscle belly. Measurements were conducted in a quiet, dimly lit room, with participants seated in the Frankfurt Horizontal Plane position. Participants were asked to clench their teeth three times and then relax. Each EMG recording lasted 10 seconds and was repeated twice. From each 10-second recording, three 2-second segments from the first 6 seconds were selected, and the average EMG activity was calculated.

    From baseline to the end of treatment at 8 weeks

Secondary Outcomes (3)

  • Trigger Point

    From baseline to the end of treatment at 8 weeks

  • Presence and severity of Temporomandibular Joint Disorder (TMD) symptoms

    From baseline to the end of treatment at 8 weeks

  • Bruxism

    From baseline to the end of treatment at 8 weeks

Study Arms (2)

Manual Therapy Group

EXPERIMENTAL

The term manual therapy includes a wide variety of detailed applications ranging from joint-oriented applications (joint mobilizations and/or manipulations) or soft tissue techniques (muscle stretching or trigger point therapy) to therapeutic exercises. Manual therapy in our study was used to restore normal temporomandibular joint range of motion, reduce local ischemia, stimulate proprioception, break fibrous adhesions, stimulate synovial fluid production and reduce pain.

Other: Manual Therapy

Exercise Group

EXPERIMENTAL

Exercise therapy, one of the physical therapy applications, has an important place in the rehabilitation of musculoskeletal disorders. With this method, it is aimed to decrease inflammation, increase coordination of muscle activity, promote tissue repair and regeneration, relieve pain and restore normal function. In addition to the special exercises known as Rocabado exercises which are used in the treatment of temporomandibular joint, various studies have been performed in which mobilization, coordination, posture and relaxation exercises were used for the treatment of disorders related to the masticatory system and it has been emphasized that studies on this subject should be continued.

Other: Home Exercise Therapy

Interventions

Various soft tissue and joint mobilizations, intramuscular stretches, trigger point treatments, and intraoral applications for the temporomandibular joint were performed in 15 randomly selected bruxism patients. Manual therapy was applied twice weekly over eight weeks, each session lasting approximately 45 minutes. Techniques included trigger point therapy, myofascial release, intraoral mobilizations to the masseter, medial and lateral pterygoid, and temporalis tendons, post-isometric relaxation for masticatory muscles, cervical traction, and suboccipital and cervical fascial release. The manual therapy procedure, which was applied in the supine position and lasted approximately 40 minutes for 8 weeks

Manual Therapy Group

The exercise group consisted of 15 randomly selected bruxist individuals and aimed to reduce pain, decrease involuntary contractions of masticatory muscles, increase their nutrition, flexibility and coordination, and strengthen weak muscles with exercise therapy. The exercise program included Rocabado exercises, stretching of the platysma, masticatory and cervical muscles, resistance training (mouth opening, protrusion, and lateral mandibular movements), and postural exercises. Exercises were performed while sitting in a chair with back support in front of a mirror. Each exercise was repeated 10 times. The duration of each session was 25-30 minutes. repeat the home exercises three times a week for 8 weeks. Weekly phone calls were made to encourage compliance. In addition, a video explaining the exercises in detail was shared with all participants in the group in order to ensure that the exercises were not forgotten and to achieve accuracy and standardization among the participants.

Exercise Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteer students aged between 18-25
  • Answered "yes" to at least two of the six questions in the Bruxism questionnaire.
  • Is there anyone hear you grinding your teeth at night? Do you feel fatigue or pain in your jaw when you wake up in the morning? Do you feel pain in your teeth and gums when you wake up in the morning? Do you have a headache when you wake up in the morning? Do you notice that you grind your teeth during the day? Do you notice that you clench your teeth during the day?
  • 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,
  • Having more than two molar teeth missing in the posterior
  • Individuals who cannot cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University, Health Services Vocational School

Bartın, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BruxismMotor ActivityPain

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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
To ensure blinding, baseline and final outcome measurements were performed by researchers other than the physiotherapist performing manual therapy.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Thirty patients with bruxism were randomly divided into as Manual Therapy Group (15) and Home Exercise Group (15).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 9, 2025

First Posted

July 10, 2025

Study Start

December 1, 2022

Primary Completion

October 1, 2023

Study Completion

April 1, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Investgators can share the questionnaires and indexes used in the study

Shared Documents
STUDY PROTOCOL

Locations