- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04421144
Accuracy of CAD/CAM Cutting Guides and Customized Titanium Plates for Virtual Planning Transfer in Bimaxillary Orthognathic Surgeries
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Intervention:
Diagnostic procedure:
All Patients will be selected according to inclusion and exclusion criteria & Comprehensive clinical examination and understanding of patients' chief complains and needs will be carried out.
Preoperative patient photographs (Frontal, Profile, 45°, smile, and dental occlusion).
Alginate Impressions of upper & lower jaws will be taken for acquiring diagnostic dental casts.
A heat-cured acrylic resin stent will be constructed on the stone model. Using the stent, a radiographic stent will be constructed for imaging and planning procedures.
Cone Beam Computed Topography (CBCT) for the patients will be carried out. All patients will be referred to an orthodontist for presurgical phase of orthodontic treatment for decompensation and to attain stable occlusion in three points in the surgery.
Planning procedure:
All planning procedures are carried out by MZ and under the supervision of AH and MH.
Computer-aided planning & MCROS design for all patients: All planning will be done using specialized software .
One virtual 3D anatomic model of the patient will be constructed through thresholding & image fusion.
Virtual Le Fort I osteotomy and then the maxilla will be virtually adjusted according to the facial symmetry planes and clinical anthropometric analysis. Virtual simulation of the sagittal split of the mandible will be performed and the mandible position adjusted according to the bite registered.
After settling on the optimum virtual plan, designing of the cutting guides and titanium plates will then be started.
Intra-operative procedures:
The surgical procedures will be carried out by MZ under the supervisor of AH in the Oral & Maxillofacial operating floor on the 8th floor of the faculty of Oral & Dental Medicine new building.
Scrubbing and draping of the patient will be carried out in a standard fashion according to Anon 2006.
Local anaesthesia (lidocaine 2%, 1/100000 adrenaline) will be injected intraorally along the incision lines for hemostasis.
Access through a vestibular intraoral incision for maxilla & Sagittal split incision for mandible will be carried out. Dissection and reflection to reach the bone will be carried out.
Le Fort I Maxillary & Bilateral Sagittal split mandibular osteotomies will be carried out using the osteotomy cutting guides.
Complete mobilization of maxillary and mandibular segments. Reposition and fixation of the maxillary & mandibular segments using customized titanium plates.
The incisions will be closed with continuous mattress resorbable sutures .
Post-operative care:
Patients will start antibiotics 4 hours after the last intraoperative dose (Amoxicillin / Clavulanic acid 625 mg every 8 hours) for 5 days Patients will start analgesics (NSAIDs every 6 hours) for 3 days Mouthwash (Chlorhexidine 0.12%) will be prescribed for 2 more weeks.
Criteria for discontinuing or modifying intervention:
- Difficulty with the use of cutting guides and customized titanium plates.
- Inaccurate translation of the surgical plan.
Strategies to improve adherence to intervention:
Postoperative orthodontic treatment is necessary after the operation to obtain the final stable occlusion.
Concomitant care:
Not needed.
- Follow up & Evaluation:
Post-operative treatment will start immediately postoperative (4 hours). The patients will be scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months.
Within the first week postoperatively CBCT using same parameters will be ordered to calculate the difference between surgical plan and actual outcome will be evaluated.
Patient will be referred back to the orthodontist to receive his postsurgical orthodontics 4-6 weeks postoperatively.
The technique will be evaluated by applying hard tissue parameters to compare the virtual orthognathic planning (P0) with the postoperative result (P1) using 3D cephalometry and image fusion.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Exclusion Criteria:
- Patients who refused to be included in the research.
- Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: study group
using CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches.
|
patients with maxillofacial disharmony will undergo orthognathic surgery using CAD/CAM Cutting Guides and Customized Titanium Plates.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy of the surgical transfer
Tidsramme: within first week postoperatively
|
Computer software on pre/postoperative CBCT
|
within first week postoperatively
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient satisfaction: Visual analog scale (questionnaire)
Tidsramme: one week postoperative
|
Visual analog scale (questionnaire)
|
one week postoperative
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Dr.Zain protocol
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med orthognathic surgery
-
Assiut UniversityIkke rekrutterer endnuOrtognatisk kirurgi | Maxillær Hypoplasi | Læbespalte
-
Clinique Victor PauchetRekruttering
-
Diakonessenhuis, UtrechtRekrutteringLivskvalitet | Søvnapnø, obstruktivHolland
-
Instituto de Investigación Sanitaria de la Fundación...RekrutteringPtosis, øjenlågSpanien
-
Royal Surrey County Hospital NHS Foundation TrustUkendtLivmoderhalskræft | Æggelederkræft | Peritoneal kræft | Neoplasma i æggestokkene | Ovarie neoplasma epitelialDet Forenede Kongerige
-
University of Colorado, DenverRekrutteringForbedret restitution efter operation | Gynækologisk sygdomForenede Stater
-
University Hospital, GrenobleAfsluttet
-
The Second Hospital of Shandong UniversityRekrutteringLungekræft | Kirurgi | ERASKina
-
Grupo Español de Rehabilitación MultimodalInstituto de Salud Carlos III; Instituto de Investigación Sanitaria AragónRekrutteringStørre operationSpanien
-
ARCAGY/ GINECO GROUPAfsluttetOvariekræft Stadium IIIC | Ovariekræft Stadium IV | Ovariekræft Stadium IIIbFrankrig