Asymptomatic ConditionNCT07670832
Effect of Osteopathic Technique on Maximum Mouth Opening Width, Masseter Muscle Tone and Stiffness
A study testing Osteopathic Intervention Techniques in people with Asymptomatic Condition, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
The purpose of this study is to assess the effect of compression and decompression thecnique on the temporomandibular joint on maximum mouth opening width, masseter muscle tone and stiffness in asymptomatic adults, compared with a control condition consisting of cranial listening touch without therapeutic intent. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Condition
- What is being tested?
- Osteopathic Intervention Techniques
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 sitePortugal
- Study dates
- Jun 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic adults that signed the informed consent
- Functional dentition
- Preserved masticatory function
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Temporomandibular Joint Compression and Decompression Technique on Maximum Mouth Opening Width, Masseter Muscle Tone and Stiffness: A Randomized Controlled Study
The purpose of this study is to assess the effect of compression and decompression thecnique on the temporomandibular joint on maximum mouth opening width, masseter muscle tone and stiffness in asymptomatic adults, compared with a control condition consisting of cranial listening touch without therapeutic intent. Evaluations will be conducted immediately after the intervention and one week later.
Read the detailed description
The purpose of this study is to assess the Effect of Compression and Decompression Technique on the Temporomandibular Joint 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, 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.
- Conditions
- Asymptomatic Condition
- Being tested
- Osteopathic Intervention Techniques, Placebo Technique
- Keywords
- Masseter, Maximum Mouth opening Width, muscle tone, TMJ, Temporomandibular joint, stiffness
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Intervention TechniquesOther
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. 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."
Placebo TechniqueOther
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.
In addition, after placing the contacts, the investigator asks the patient not to contact the maxillary teeth with the mandibular teeth.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | In the control group, cranial listening touch without therapeutic intent using the par la voute hold was performed during 30 seconds. Receives: Other: Placebo Technique |
| Temporomandibular Compression and Decompression Technique | Experimental | 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. Receives: Other: Osteopathic Intervention Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Mouth Opening Width
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.
Measured: Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
Masseter Muscle Tone
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).
Measured: Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
Masseter muscle stiffness
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).
Measured: Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic ConditionStudies of the same condition, open and under way.
- 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
- Model description
- The study consists in 2 interventions, carried out with a one-week interval between each one.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Campelo, Principal investigator, E2S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670832
- Sponsor's protocol ID
- OST1-021
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20436241Murphy 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.
PubMed 24278954Goulet 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.
PubMed 9656895Dimitroulis G. Temporomandibular disorders: a clinical update. BMJ. 1998 Jul 18;317(7152):190-4. doi: 10.1136/bmj.317.7152.190. No abstract available.
PubMed 9665905Cuccia 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.
PubMed 19142553Aird 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.
PubMed 22503549
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Temporomandibular Joint Compression and Decompression Technique on Maximum Mouth Opening Width, Masseter Muscle Tone and Stiffness: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07670832
- Acronym / sponsor ID
- OST1-021
- Conditions
- Asymptomatic Condition
- Keywords
- Masseter, Maximum Mouth opening Width, muscle tone, TMJ, Temporomandibular joint, stiffness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Jun 2026 (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.
The purpose of this study is to assess the effect of compression and decompression thecnique on the temporomandibular joint on maximum mouth opening width, masseter muscle tone and stiffness in asymptomatic adults, compared with a control condition consisting of cranial listening touch without therapeutic intent. Evaluations will be conducted immediately after the intervention and one week later.
Detailed description
The purpose of this study is to assess the Effect of Compression and Decompression Technique on the Temporomandibular Joint 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, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study consists in 2 interventions, carried out with a one-week interval between each one.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Placebo TechniqueIn the control group, cranial listening touch without therapeutic intent using the par la voute hold was performed during 30 seconds. |
| Temporomandibular Compression and Decompression Technique | Experimental | Other: Osteopathic Intervention TechniquesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Asymptomatic adults that signed the informed consent
- Functional dentition
- Preserved masticatory function
Key exclusion criteria (6 listed)
- Diagnosis of inflammatory systemic disorders
- Diagnosis of cardiovascular disorders
- Diagnosis of respiratory disorders
- Diagnosis of central nervous system disorders
- Diagnosis of rheumatic disorders
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 |
|---|---|---|
| Osteopathic Intervention TechniquesThe 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. 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." | Other | Temporomandibular Compression and Decompression Technique |
| Placebo TechniqueCranial 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. In addition, after placing the contacts, the investigator asks the patient not to contact the maxillary teeth with the mandibular teeth. | Other | Control group |
Primary outcome
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.
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 20436241Oliveira-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.
- Background: PubMed 24278954Murphy 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.
- Background: PubMed 9656895Goulet 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.
- Background: PubMed 9665905Dimitroulis G. Temporomandibular disorders: a clinical update. BMJ. 1998 Jul 18;317(7152):190-4. doi: 10.1136/bmj.317.7152.190. No abstract available.
- Background: PubMed 19142553Cuccia 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.
- Background: PubMed 22503549Aird 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.
- Individual participant dataSharing planned: No
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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.
Natália MO Campelo principal investigator
E2S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Intervention Techniques in people with Asymptomatic Condition, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natália MO Campelo, PhD (+351 222 061 000, nmc@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Mouth Opening Width (time frame: Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07670832, which also lists 6 linked publications.
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 29 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.