Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism

Not Applicable

• Conditions: Bruxism; TMJ Pain
• Interventions: Other: Deep friction massage; Other: control group; Other: Pressure release

• Registration Number: NCT03753529
• Lead Sponsor: Cairo University

Brief Summary

Hypothesis

1. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on pain level in patients with bruxism.

2. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Range of Motion in patients with bruxism.

3. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Sleep Quality Index in patients with bruxism.

4. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on proprioception awareness in patients with bruxism.

5. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Stress in patients with bruxism.

6. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Anxiety in patients with bruxism.

7. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Temporomandibular (TMJ) function in patients with bruxism.

8. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Oral Health Impact Profile in patients with bruxism.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-02
• Study First Submitted QC: 2018-11-22
• Last Update Submitted: 2018-11-22
• Study First Posted: 2018-11-27
• Last Update Posted: 2018-11-27
• Study Start: 2019-01
• Primary Completion: 2020-01
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. The volunteers diagnosed with bruxism based on the criteria of the American Academy of Sleep Medicine
2. Positive self-report of awake bruxism.
3. Self-report of muscle fatigue or tenderness on awakening.
4. Sleeping partner reports of grinding sounds during the night in the last 6 months, or awake clenching.

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Exclusion Criteria

1. Severe psychological disorder and/or the use of antipsychotic psychotropic drugs(with the exception of anxiety and depression).
2. Using medications that influence sleep or motor behavior.
3. Direct trauma or past surgery in the orofacial region.
4. On physical, speech, dental, or psychological therapy at the time of study entry.
5. Currently undergoing physical therapy for TMD.
6. Neurological or central nervous system and/or peripheral nervous system disorders or history of neuromuscular disease.
7. The presence of prosthesis or extensive prosthetic restorations and the presence of gross malocclusion.
8. More than two missing teeth, except third molars;
9. Systemic and/or degenerative diseases.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
deep friction massage group	Deep friction massage	-
control group	control group	-
pressure release group	Pressure release	-

Primary Outcome Measures

Name	Time	Method
changes of Trigger point pressure pain threshold	Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).	To compare pressure pain threshold (PPT) values for selected muscles (temporalis, masseter, digastric and lateral pterygoid) in patients with bruxism before and after treatment using Pressure Algometer.
Changes of mandibular range of motion at month of treatment	Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).	Vernier caliper used to measure opening, lateral movements, protraction and retraction.

Secondary Outcome Measures

Name	Time	Method
Changes of proprioception awareness	Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).	Measure ability of patient before treatment and after to move mandible to specific angle(measured by vernier caliper) identified before test
Stress	Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).	Using Perceived Stress Scale to measure stress which consist of 10 items. The 10 items in the scale inquire about feelings and thoughts that tap the degree to which respondents find their current life situation unpredictable, uncontrollable and stressful. Respondents indicate how often in the past month they have felt or thought a certain way on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). The higher the score the higher the perceived stress is. The scale correlates with different psychosocial measures specifically depression, anxiety, and perception of poor health as well as with decreased satisfaction with self, job and life in general.
Anxiety	Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).	Measured using the State-triat Anxiety Inventory. It consists of two independent scales, with 20 questions each, measuring anxiety as a trait (in general) and as a state (at the moment). Each question is scored (from 1 to 4), and scores for the scales range from 20 to 80 as follows: mild anxiety (20 to 34); moderate anxiety (35 to 49); high anxiety (50 to 64); and very high anxiety (65 to 80).
Changes of quality of sleep at month of treatment	Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).	Using The Pittsburgh Sleep Quality Index, It consists of 19 questions grouped under seven domains: subjective sleep quality; sleep latency; sleep duration; usual sleep efficiency; sleep disturbances; use of medications; and diurnal dysfunction. Each domain is scored (0 to 3) and a total score (0 to 21) is calculated as follows: scores ranging from 0 to 4 are indicative of good sleep quality; scores from 5 to 10 suggest poor sleep quality; scores above 10 are suggestive of sleep disorders. Five other questions are answered by participants' spouses or partners, and further characterize sleep quality.
Temporomandibular (TMJ) function	Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).	Using Temporomandibular Disorder (TMD) Disability Index Questionnaire,The TMD Disability Index consists of ten questions regarding disability associated with TMD, and each question is scored from 0-4. Higher scores represent greater levels of disability.
Changes in Oral Health Impact Profile.	Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).	using Oral Health Impact Profile.(OHIP), The OHIP-14 is a 14-items questionnaire designed to measure self-reported functional limitation that focuses on seven dimensions of impact (functional limitation, pain, psychological discomfort, physical disability, psychological disability, social disability and handicap) with participants being asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4) using a twelve-months recall period.