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Completed

NCT Number: NCT06610435

Effects of Manual Therapy and Home Exercise in Bruxism

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University, Faculty of Dentistry

Ankara, Emniyet, 06560, Turkey (Türkiye)

About this study

Bruxism is a common parafunctional habit defined as clenching and/or grinding of teeth occurring during sleep and/or wakefulness. Although the etiology is not known exactly, there is a consensus that it is multifactorial. Emotional stress is one of the important factors leading to bruxism. It has been shown that a stressful life has an important effect in explaining clenching during the day. In addition to stress, previous studies showing that psychiatric disorders, especially depression and anxiety disorders, accompany TMD and bruxism.

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. In the study thirty bruxists over the age of 18 were included in the research protocol. 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). The normal distribution of the groups was tested with Kolmogorov-Smirnov. Paired Samples t test was used for intra-group comparisons at T1 and T2, and Independent t test was used for inter-group comparisons. The statistical significance level was accepted as p<0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

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.

Primary outcomes

  1. Pain Level

    Time frame: From baseline to the end of treatment at 8 weeks

    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

  2. Sleep Quality Index

    Time frame: From baseline to the end of the treatment at 8 weeks

    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.

  3. Stress level

    Time frame: From baseline to the end of the treatment at 8 weeks

    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.

  4. Quality of Life

    Time frame: From baseline to the end of the treatment at 8 weeks

    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.

Secondary outcomes

  1. Presence and severity of Temporomandibular Joint Disorder (TMD) symptoms

    Time frame: From baseline to the end of the treatment at 8 weeks

    It was examined with Fonseca Anamnestic Index (FAI). It was developed in 1994 by Fonseca et al. and consists of 10 questions investigating pain in the head and TMJ (Table 2.) The questionnaire includes various questions about joint, head and neck pain, joint movements, parafunctional habits, impaired occlusion and emotional stress. Participants were asked to answer 'Yes' (10 points), 'No' (0 points) and 'Sometimes' (5 points) to each question and TMD was classified as none, mild, moderate and severe according to the total score.

  2. Bruxism

    Time frame: From baseline to the end of the treatment at 8 weeks

    It was examined with Bruxism Questionnaire. According to the survey questions prepared by referencing the studies of Pintado et al and Shetty et al, it was stated that individuals who answered "Yes" to at least two of the questions specified in the survey can be called bruxists. The total score range varies between 0-6.

  3. Trigger Point

    Time frame: From baseline to the end of the treatment at 8 weeks

    While evaluating the trigger points in the masticatory and neck muscles, the tense muscle was palpated with a fingertip. Palpation was performed along the long axis of the tense muscle and the most sensitive point was determined. Sudden reaction or vocal response of the patient with light pressure applied to this point and the presence of reflected pain in a region distant from this region indicated the presence of a trigger point. Evaluation was performed in 14 muscles and the muscles with trigger points and the total number of trigger points were recorded.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Effects of Manual Therapy and Home Exercise Treatment on Pain, Stress, Sleep and Life Quality in Patients with Bruxism: a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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