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CompletedNCT06610435Updated Sep 24, 2024

Effects of Manual Therapy and Home Exercise in Bruxism

An interventional study of Manual Therapy and Home Exercise in Bruxism, Manual Theapy and Exercise, sponsored by Ankara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-09-24.

Sponsored by Ankara University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2024, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Bruxism
  • Manual Theapy
  • Exercise
  • Orofacial Pain

Keywords

  • Manual Therapy
  • Exercise
  • Physiotherapy
  • Bruxism
  • Sleep and Life Quality
03

In context

Bruxism

166 studies on the registry are indexed under Bruxism; 38 are open to participants now.

This study's enrollment of 30 is below the median of 38 across 103 interventional studies indexed under Bruxism.

Browse Bruxism studies →

Lead sponsor

Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Manual Therapy

    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

  • Experimental
    Home Exercise

    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

  • ProcedureManual Therapy

    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

  • ProcedureHome Exercise

    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.

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes

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

    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 \&#39;Yes\&#39; (10 points), \&#39;No\&#39; (0 points) and \&#39;Sometimes\&#39; (5 points) to each question and TMD was classified as none, mild, moderate and severe according to the total score.

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

  2. Bruxism

    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.

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

  3. Trigger Point

    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.

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

07

Study locations

1 site
  • Ankara University, Faculty of Dentistry
    Ankara, Emniyet 06560, Turkey
08

References and documents

Individual participant data

Plan to share: Yes — We can share the questionnaires and indexes used in the study

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06610435
Lead sponsor
Ankara University
Responsible party
Merve Berika Kadıoğlu (Lecturer, Ankara University) — Principal investigator
First posted
Sep 24, 2024
Start date
May 1, 2024
Primary completion
Aug 20, 2024
Completion
Aug 25, 2024
Last update
Sep 24, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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