- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04942743
Clinical & MRI Finding of TMJ Disk Perforation
Studieoversikt
Detaljert beskrivelse
The retrospective study included patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University. The sample originally included patients who provided consent to participate in this study and who ultimately underwent treatment for TMJD between 2008 and 2019.
Exclusion Inclusion criteria: Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous fibrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.
the study included 2 groups group 1: normal TMJ patients group 2: patients with TMJ internal derangement
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Nasr City
-
Cairo, Nasr City, Egypt, 11765
- Faculty of Dental Medicine Alazhar University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University.
Exclusion Criteria:
- Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous fibrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
kontrollgruppe
pasienter med normal TMJ
|
MRI OF TMJ
|
Study group
patients with TMJ internal derangement
|
MRI OF TMJ
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
joint pain (VAS),
Tidsramme: pre treatment
|
pain index scores were measured using a 10-point visual analogue scale (VAS), with 0 indicating absence of pain and 10 indicating the worst pain.
|
pre treatment
|
(MVMO)
Tidsramme: pretreatment
|
mouth opening
|
pretreatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
joint sound
Tidsramme: pretreatment
|
joint sound was then determined by combining 3 means: (1) palpation of the TMJ zone by the clinician, (2) the patient's self-reporting regarding whether the joint sound could be heard, and (3) auscultation of the TMJ zone with the stethoscope.
|
pretreatment
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ayman Hegab, Phd, AlAzhar university
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- AUAREC20200501-12
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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