- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Natália MO Campelo, PhD
- Telefonní číslo: +351 222 061 000
- E-mail: nmc@ess.ipp.pt
Studijní místa
-
-
-
Porto, Portugalsko, 4200-072
- Escola Superior de Saúde (E2S)
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: 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. |
|
Experimentální: 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."
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Maximum Mouth Opening Width
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Natália MO Campelo, E2S
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- OST1-021
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .