Effects of Manual Therapy and Home Exercise in Bruxism

NCT06610435 | Completed

• 1 other identifier: 2024-SBB-0289
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: This trial aimed to examine the effects of manual therapy and home exercise treatments on pain, sleep quality, stress level and quality of life in patients with bruxism. Methods: Thirty bruxists over the age of 18 were included in the study. The patients were randomly divided into Manual Therapy Group (MTG) and Home Exercise Group (HEG). Before treatment (T1) demographic information was obtained from all patients, they were asked to fill out the Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS), Fonseca Anamnestic Index (FAI) and Quality of Life Scale/Short Form-36 (SF-36) and number of trigger points and pain levels were determined at baseline. Manual therapy and home exercises were applied to both groups for 8 weeks and all tests were repeated and re-evaluated at the end of 8 weeks (T2). After that, the data was analyzed with statistical tests.

Conditions

Bruxism; Manual Theapy; Exercise; Orofacial Pain

Keywords

Manual Therapy; Exercise; Physiotherapy; Bruxism; Sleep and Life Quality

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

• Sleep Quality Index

  It was examined with Pittsburgh Sleep Quality Index (PSQI). It is a 24-question scale developed by Buysse et al. in 1989 that evaluates sleep quality in the last month, and the last 5 questions are used only for clinical evaluation. The sum of the scores of 7 components including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use and daytime dysfunction gives the total score index. The total PDQI score ranges from 0 to 21; a score above 5 points indicates poor sleep quality; a score of 5 points or less indicates good sleep quality.

  From baseline to the end of the treatment at 8 weeks

• Stress level

  It was examined with Perceived Stress Scale.It was developed by Cohen, Kamarck and Mermelstein (1983) and consists of 14 items. The scale consists of two sub-dimensions: stress/discomfort perception and self-efficacy perception. Participants rate the stress they perceive in the scale as "0" never, "1" almost never, "2" sometimes, "3" often, and "4" very often. The stress level perceived by individuals is determined by summing the scores obtained from the items. A score between 0-56 points is obtained from the scale and the higher the score, the higher the perceived stress level.

  From baseline to the end of the treatment at 8 weeks

• Quality of Life

  It was examined with Short Form-36 (SF-36) Quality of Life Scale. SF-36 was developed by the Rand Corporation to obtain information about the health status of the individual. It consists of 8 sub-dimensions and 36 items. The sub-dimensions consist of physical function, social function, physical role difficulty, emotional state difficulty, mental health, energy/vitality, pain, and general perception of health. "0" represents the worst health status, while "100" represents the best health status. Each sub-dimension is evaluated individually without calculating the total score, and in our study, general health perception was evaluated.

  From baseline to the end of the treatment at 8 weeks

Secondary Outcomes (3)

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

  From baseline to the end of the treatment at 8 weeks

• Bruxism

  From baseline to the end of the treatment at 8 weeks

• Trigger Point

  From baseline to the end of the treatment at 8 weeks

Study Arms (2)

Manual Therapy

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.

Procedure: Manual Therapy

Home Exercise

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.

Procedure: Home Exercise

Interventions

Manual Therapy PROCEDURE

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. Soft tissue mobilization techniques were applied bilaterally on the trigger points in the masseter, temporal, lateral and medial pterygoid muscles of the masticatory muscles in the transverse direction from inside and outside the mouth. In addition, deep friction massage and myofascial relaxation techniques were applied to suprahyoid and infrahyoid muscles, sternocleidomastoid, scalene, upper trapezius, levator scapula and suboccipital muscles until relaxation was felt. In addition, distraction and bridging techniques were applied in the suboccipital region to release the tissue and fascia techniques were applied in the cervical region to loosen the fascia. The manual therapy procedure, which was applied in the supine position and lasted approximately 40 minutes for 8 weeks

Manual Therapy

Home Exercise PROCEDURE

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. These exercises consist of resistant isometric jaw movements to increase coordination and relaxation of the masticatory muscles (post isometric relaxation technique), Rocabado exercises, stretching and posture exercises for temporal, masseter and suprahyoid muscles as well as neck muscles. All individuals in this group were taught the programmed exercises practically and were asked to repeat the home exercises (lasting approximately 25 minutes) three times a week for 8 weeks. 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.

Home Exercise

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University, Faculty of Dentistry

Ankara, Emniyet, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bruxism; Motor Activity; Facial Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Thirty patients with bruxism were randomly divided into as Manual Therapy Group (15) and Home Exercise Group (15).

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 24, 2024
• Study Start: May 1, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 25, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)