- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Natália MO Campelo, PhD
- Numero di telefono: +351 222 061 000
- Email: nmc@ess.ipp.pt
Luoghi di studio
-
-
-
Porto, Portogallo, 4200-072
- Escola Superior de Saúde (E2S)
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: 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. In addition, after placing the contacts, the investigator asks the patient not to contact the maxillary teeth with the mandibular teeth. |
|
Sperimentale: 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.
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."
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximum Mouth Opening Width
Lasso di tempo: 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.
|
Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
|
|
Masseter Muscle Tone
Lasso di tempo: 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).
|
Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
|
|
Masseter muscle stiffness
Lasso di tempo: 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).
|
Immediately after the intervention. Since the protocol has two interventions, the total time frame is one week.
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Natália MO Campelo, E2S
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- OST1-021
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .