- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07670832
Effect of Osteopathic Technique on Maximum Mouth Opening Width, Masseter Muscle Tone and Stiffness
Effect of Temporomandibular Joint Compression and Decompression Technique on Maximum Mouth Opening Width, Masseter Muscle Tone and Stiffness: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to assess the Effect of Compression and Decompression Technique on the Temporomandibular Joint (Liem et al, 2012) on masseter muscle tone and stiffness (always assessed on the right side). Muscle properties will be evaluated using the Myoton device (Myoton AS, Tallinn, Estonia), a non-invasive instrument that measures biomechanical and viscoelastic properties of muscles, such as stiffness and tone (the parameters used in the results).
In addition, maximum mouth-opening width will be assessed by measuring the distance between the upper and lower central incisors using a universal caliper (Oliveira-Campelo et al., 2010), recorded in millimeters.
These outcomes will be compared with a control condition consisting of cranial listening touch without therapeutic intent .
The study will include asymptomatic adults without diagnoses of systemic inflammatory diseases, cardiovascular diseases, respiratory diseases , central nervous system disorders, or rheumatic pathologies. Additional exclusion criteria include: use of fixed orthodontic appliances within the past 3 months; visual impairment affecting balance or proprioception; history of maxillofacial surgery; trauma to the cranial or cervical region within the last 6 months ; ongoing pharmacological treatments that may interfere with muscle tone or pain perception (e.g., muscle relaxants, tricyclic antidepressants, benzodiazepines) and third/fourth year osteopathy students.
Measurements of the tone/stiffness of the masseter muscle and maximum mouth opening width will conducted before, immediately after the intervention and one week later the study will be repeated in each participant.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natália MO Campelo, PhD
- Phone Number: +351 222 061 000
- Email: nmc@ess.ipp.pt
Study Locations
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-
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Porto, Portugal, 4200-072
- Escola Superior de Saúde (E2S)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Asymptomatic adults that signed the informed consent
- Functional dentition
- Preserved masticatory function
Exclusion Criteria:
- Diagnosis of inflammatory systemic disorders
- Diagnosis of cardiovascular disorders
- Diagnosis of respiratory disorders
- Diagnosis of central nervous system disorders
- Diagnosis of rheumatic disorders
- Visual disturbance affecting balance or proprioception
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control group
In the control group, cranial listening touch without therapeutic intent using the par la voute hold was performed during 30 seconds.
|
Cranial listening touch without therapeutic intent consists of, with the patient in the supine position and the investigator at the head of the bed, the investigator placing bilateral contacts on the patient's skull with the first fingers in contact with each other, without contacting the skull, the second fingers on the greater wing of the sphenoid, the third fingers anterior to the ear, the fourth fingers posterior to the ear, and the fifth fingers in contact with the squamous part of the occipital bone (Busquet, 2002). In addition, after placing the contacts, the investigator asks the patient not to contact the maxillary teeth with the mandibular teeth. |
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Experimental: Temporomandibular Compression and Decompression Technique
The intervention consisted of two phases: The first one consisting in mandibular compression, applied for 30 seconds.
The second phase is applied right after, consisting in mandibular decompression, applied for 30 seconds.
|
The temporomandibular joint compression and decompression technique consists of, with the patient in the supine position and the investigator at the head, hooking the middle fingers beneath the angles of the mandible while the basal joints cover the joints and the palms cover the ears and temporal regions (Liem et al, 2012).
First, a light cranially-directed pressure is applied to the mandible for 30 seconds to release restrictions and stretch the intracranial membrane.
Subsequently, the vector is reversed, and a gentle caudally-directed traction is applied for another 30 seconds to free the joint space."
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Mouth Opening Width
Time Frame: Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
|
For the assessment of the maximum mouth opening width was measured the distance between the upper and lower central incisors was measured in millimeters (mm) using a universal caliper.
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Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
|
|
Masseter Muscle Tone
Time Frame: Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
|
The assessment of masseter muscle tone was performed using Myoton (Myoton AS Talin, Estonia), a non-invasive approach to comprehensively evaluate the biomechanical and viscoelastic properties of muscles.
Muscle tone is calculated using the maximum frequency of oscillation and tissue deformation detected by the transducer (Hz).
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Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
|
|
Masseter muscle stiffness
Time Frame: Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
|
The assessment of masseter muscle stiffness was performed using Myoton (Myoton AS Talin, Estonia), a non-invasive approach to comprehensively evaluate the biomechanical and viscoelastic properties of muscles.
Muscle stiffness is calculated based on equations calculated from the acceleration of the testing probe during oscillations (N/m).
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Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Natália MO Campelo, E2S
Publications and helpful links
General Publications
- Oliveira-Campelo NM, Rubens-Rebelatto J, Marti N-Vallejo FJ, Alburquerque-Sendi N F, Fernandez-de-Las-Penas C. The immediate effects of atlanto-occipital joint manipulation and suboccipital muscle inhibition technique on active mouth opening and pressure pain sensitivity over latent myofascial trigger points in the masticatory muscles. J Orthop Sports Phys Ther. 2010 May;40(5):310-7. doi: 10.2519/jospt.2010.3257.
- Aird L, Samuel D, Stokes M. Quadriceps muscle tone, elasticity and stiffness in older males: reliability and symmetry using the MyotonPRO. Arch Gerontol Geriatr. 2012 Sep-Oct;55(2):e31-9. doi: 10.1016/j.archger.2012.03.005. Epub 2012 Apr 13.
- Cuccia A, Caradonna C. The relationship between the stomatognathic system and body posture. Clinics (Sao Paulo). 2009;64(1):61-6. doi: 10.1590/s1807-59322009000100011.
- Murphy MK, MacBarb RF, Wong ME, Athanasiou KA. Temporomandibular disorders: a review of etiology, clinical management, and tissue engineering strategies. Int J Oral Maxillofac Implants. 2013 Nov-Dec;28(6):e393-414. doi: 10.11607/jomi.te20.
- Goulet JP, Clark GT, Flack VF, Liu C. The reproducibility of muscle and joint tenderness detection methods and maximum mandibular movement measurement for the temporomandibular system. J Orofac Pain. 1998 Winter;12(1):17-26.
- Dimitroulis G. Temporomandibular disorders: a clinical update. BMJ. 1998 Jul 18;317(7152):190-4. doi: 10.1136/bmj.317.7152.190. No abstract available.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OST1-021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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