BruxismNCT03753529
Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism
A study testing Deep friction massage and Pressure release in people with Bruxism and TMJ Pain, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- What is being tested?
- Deep friction massage and Pressure release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The volunteers diagnosed with bruxism based on the criteria of the American Academy of Sleep Medicine
- Positive self-report of awake bruxism.
- Self-report of muscle fatigue or tenderness on awakening.
- Sleeping partner reports of grinding sounds during the night in the last 6 months, or awake clenching.
Who cannot join
- Severe psychological disorder and/or the use of antipsychotic psychotropic drugs(with the exception of anxiety and depression).
- Using medications that influence sleep or motor behavior.
- Direct trauma or past surgery in the orofacial region.
- On physical, speech, dental, or psychological therapy at the time of study entry.
- Currently undergoing physical therapy for TMD.
- Neurological or central nervous system and/or peripheral nervous system disorders or history of neuromuscular disease.
Show all 9Show fewer
- The presence of prosthesis or extensive prosthetic restorations and the presence of gross malocclusion.
- More than two missing teeth, except third molars;
- Systemic and/or degenerative diseases.
About this study
Hypothesis
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on pain level in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Range of Motion in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Sleep Quality Index in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on proprioception awareness in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Stress in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Anxiety in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Temporomandibular (TMJ) function in patients with bruxism.
- 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.
- Being tested
- Deep friction massage, Pressure release, control group
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep friction massageOther
Submitted to three session weekly 30-minute sessions of therapy will performed by the administration of sliding and kneading maneuvers of the masseter and temporalis muscles, bilaterally,lateral pterygoid and digastric over four consecutive weeks (total:12 sessions) Sliding consisted of a unidirectional movement in which part of the therapist's hand (mainly the fingertips) will used, moving from the proximal to the distal portion of the face with constant, progressive pressure compatible with the status of each tissue. The degree of pressure varied depending on the level of pain, sensitivity and tension in each individual. Kneading consisted of a gripping maneuver of a muscle group or portion of a muscle.Then follow-up with a passive stretch to the muscle. This will repeated for three to five times for three sessions per week for 4 weeks.
Pressure releaseOther
Also called Ischemic pressure and ischemic compression (IC)
First, using a pincer grasp moved throughout the fibers of the pterygoid, masseter, digastric and temporalis muscles to palpate the muscle aiming to locate a trigger point . A common location is detected according to Simon and Travell book. Once located on the trigger point, apply an IC by gradually applying pressure to the trigger point with your thumb. Keep in communication with the patient, checking to ensure that in staying within the limits of his pain tolerance. Hold this technique for approximately 20 seconds to 1 minute, patient tells you that pain has diminished, or until feels the muscle fibers begin to relax under your pressure. Once feel this release, gradually release pressure. All identified trigger points were treated. Then follow-up with a passive stretch to the muscle. This will repeated for three to five times for three sessions per week for 4 weeks.
control groupOther
Also called Stretching and transcutaneous electrical nerve stimulation
Stretching and transcutaneous electrical nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| deep friction massage group | Experimental | Not described Receives: Other: Deep friction massage |
| pressure release group | Experimental | Not described Receives: Other: Pressure release |
| control group | Experimental | Not described Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of Trigger point pressure pain threshold
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.
Measured: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Changes of mandibular range of motion at month of treatment
Vernier caliper used to measure opening, lateral movements, protraction and retraction.
Measured: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Secondary outcomes (6)
Changes of proprioception awareness
Measure ability of patient before treatment and after to move mandible to specific angle(measured by vernier caliper) identified before test
Measured: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Stress
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.
Measured: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Anxiety
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).
Measured: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Changes of quality of sleep at month of treatment
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.
Measured: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Temporomandibular (TMJ) function
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.
Measured: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Changes in Oral Health Impact Profile.
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.
Measured: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAhmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753529
- Sponsor's protocol ID
- P.T.REC/012/001936
- Status last verified
- Nov 2018
- First submitted
- 2 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism
- ClinicalTrials.gov ID
- NCT03753529
- Acronym / sponsor ID
- P.T.REC/012/001936
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on pain level in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Range of Motion in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Sleep Quality Index in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on proprioception awareness in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Stress in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Anxiety in patients with bruxism.
- There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Temporomandibular (TMJ) function in patients with bruxism.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| deep friction massage group | Experimental | Other: Deep friction massage |
| pressure release group | Experimental | Other: Pressure release |
| control group | Experimental | Other: control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The volunteers diagnosed with bruxism based on the criteria of the American Academy of Sleep Medicine
- Positive self-report of awake bruxism.
- Self-report of muscle fatigue or tenderness on awakening.
- Sleeping partner reports of grinding sounds during the night in the last 6 months, or awake clenching.
Key exclusion criteria (9 listed)
- Severe psychological disorder and/or the use of antipsychotic psychotropic drugs(with the exception of anxiety and depression).
- Using medications that influence sleep or motor behavior.
- Direct trauma or past surgery in the orofacial region.
- On physical, speech, dental, or psychological therapy at the time of study entry.
- Currently undergoing physical therapy for TMD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep friction massageSubmitted to three session weekly 30-minute sessions of therapy will performed by the administration of sliding and kneading maneuvers of the masseter and temporalis muscles, bilaterally,lateral pterygoid and digastric over four consecutive weeks (total:12 sessions) Sliding consisted of a unidirectional movement in which part of the therapist's hand (mainly the fingertips) will used, moving from the proximal to the distal portion of the face with constant, progressive pressure compatible with the status of each tissue. The degree of pressure varied depending on the level of pain, sensitivity and tension in each individual. Kneading consisted of a gripping maneuver of a muscle group or portion of a muscle.Then follow-up with a passive stretch to the muscle. This will repeated for three to five times for three sessions per week for 4 weeks. | Other | deep friction massage group |
| Pressure releaseAlso: Ischemic pressure and ischemic compression (IC)First, using a pincer grasp moved throughout the fibers of the pterygoid, masseter, digastric and temporalis muscles to palpate the muscle aiming to locate a trigger point . A common location is detected according to Simon and Travell book. Once located on the trigger point, apply an IC by gradually applying pressure to the trigger point with your thumb. Keep in communication with the patient, checking to ensure that in staying within the limits of his pain tolerance. Hold this technique for approximately 20 seconds to 1 minute, patient tells you that pain has diminished, or until feels the muscle fibers begin to relax under your pressure. Once feel this release, gradually release pressure. All identified trigger points were treated. Then follow-up with a passive stretch to the muscle. This will repeated for three to five times for three sessions per week for 4 weeks. | Other | pressure release group |
| control groupAlso: Stretching and transcutaneous electrical nerve stimulationStretching and transcutaneous electrical nerve stimulation | Other | control group |
Primary outcome
changes of Trigger point pressure pain threshold
Time frame: 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
Time frame: 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.
6 secondary outcomes
Changes of proprioception awareness
Time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Stress
Time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Anxiety
Time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Changes of quality of sleep at month of treatment
Time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Temporomandibular (TMJ) function
Time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Changes in Oral Health Impact Profile.
Time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Deep friction massage and Pressure release in people with Bruxism and TMJ Pain, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of Trigger point pressure pain threshold (time frame: Pre- and post-treatment (twelve treatment sessions within one month, three sessions per week).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018; AzTrials last refreshed its copy on 1 Nov 2026.