NCT06450782

Brief Summary

Bruxism is a repetitive jaw muscle activity that occurs during sleep or while awake, characterized by teeth clenching or grinding. Bruxism affects millions of people worldwide and is considered one of the most harmful activities for the stomatognathic system due to its morphological, pathophysiological, psychosocial features and clinical consequences. Repetitive teeth clenching and grinding movements can cause spasms, stiffness, pain, and activity changes in the chewing muscles. Since bruxism is a disorder that depends on many variables, there is no single, specific treatment and multidisciplinary approaches are often required. Most treatment strategies are conservative and symptomatic, aiming to prevent the consequences of the disorder. The main purpose of physiotherapy techniques is to reduce the negative effects of bruxism on the chewing system. Physiotherapy techniques include exercises, manual therapy, electrotherapy, acupuncture, and posture awareness. It is not clear in the literature which physiotherapy techniques are effective in the management of bruxism; Therefore, more controlled studies need to be conducted. When studies in the literature are examined, no studies have been found that objectively investigate the effectiveness of relaxation techniques alone in people with muscle pain and increased muscle stiffness due to teeth clenching problems. Within the scope of this project, it is planned to investigate the effectiveness of the myofascial release technique (MRT) and post-isometric relaxation technique (PİRT) using the grastone tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 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

First Submitted

Initial submission to the registry

June 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

June 5, 2024

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Muscle Stiffness

    MyotonPRO (Muomeetria Ltd., Tallinn, Estonia) will be used to measure the stiffness of the muscles. This device works by producing a mechanical impulse on the skin over the muscle being measured. Mechanical oscillations of muscles created by mechanical impulses are measured by MyotonPRO. Muscle stiffness is measured in Newtons per meter (N/m). This method can determine the muscle's resistance to deforming forces or muscle stiffness. In the study, measurements will be made at room temperature at approximately 25°C, and after the participants sit on a chair for 5 minutes. During the measurement, participants will be asked to contact the SCM and masseter muscles with maximum force, and the most prominent location of the muscles will be marked. The stiffness of both muscles will be measured in both relaxed and maximum contraction conditions. All measurements will be taken 3 times and their averages will be calculated.

    1 Day

  • Pain Intensity

    For pain intensity according to VAS, "no pain" is usually rated as 0 points and "worst pain imaginable" as 10 points (10 cm scale). Ranges for pain intensity; \<3 is mild pain, 3-6 is moderate pain, \>6 is severe pain.

    1 Day

Secondary Outcomes (1)

  • Range Of Montion

    1 Day

Study Arms (3)

PIR Group

EXPERIMENTAL

Participants in the PIR Group will apply one session of post-isometric relaxation technique.

Other: Post-isometric Relaxation TechniqueOther: Control

MR Grup

EXPERIMENTAL

Participants in the MR Group will apply one session of myofascial release technique.

Other: Myofascial Release Technique

Control Group

NO INTERVENTION

No intervention will be made to the participants in the Control Group.

Interventions

Sternocleidomastoid muscle Participants are asked to stretch their necks in a spuni position and then turn their heads as far to the side of the target muscle (right side) as possible until a sensation occurs that causes discomfort in the targeted SCM. In this case, the participants are asked to moderately isometrically contract the SKM muscle for 5 seconds and then relax for 3 seconds and the cervical spine is moved to the new barrier. Masseter muscle Participants are positioned in a sitting position. The jaw is opened as wide as possible. The index and middle fingers of one hand are placed over the lower teeth. The weight of the hand is allowed to provide flexion and traction is applied directly to the midline. In this case, the participants are asked to moderately isometrically contract the bilateral masseter muscles for 5 seconds, then relax for 3 seconds and the participant moves his chin to the new barrier.

PIR Group

Sternocleidomastoid muscle The head is slightly elevated with the help of a folded towel to prevent discomfort that may develop depending on the position. The researcher sits in a chair next to the participant's head. The chair is placed at approximately 45° to the participant's neck. The participant's head is rotated 30° towards the opposite side of the treated side. The Graston instrument contacts the upper part of the SCM approximately 2 cm below the mastoid process. Masseter muscle It works both ways. The Graston instrument is placed on the zygomatic process of the temporal bone, approximately 1 cm in front of the ear. The soft tissue is pressed until the bone is contacted. This connection with the periosteum is maintained and a lower tension line is created towards the mandible angle. This line of tension is continued up to the mandible, where the periosteum also comes into play. It is repeated several times.

MR Grup
ControlOTHER

Participants will rest for thirty minutes.

PIR Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed with bruxism Being willing and volunteer to work

You may not qualify if:

  • Having a neurological, psychiatric or systemic disease Being addicted to alcohol and drugs Getting dental treatment or physical therapy Using an occlusal splint being pregnant actively having cancer Planning surgery for relevant areas Not having more than two molars Using removable dentures Receiving treatment for the temporomandibular joint in the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunus Emre TÜTÜNEKEN

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bruxism

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

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

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 10, 2024

Study Start

June 15, 2024

Primary Completion

August 15, 2024

Study Completion

October 15, 2024

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations