- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03533309
Accuracy of Computer Guided Versus Conventional Ridge Splitting of Horizontal Deficient in Maxillary Anterior Alveolar Ridge
Accuracy of Computer Guided Versus Conventional Ridge Splitting of Horizontal Deficient in Maxillary Anterior Alveolar Ridge (Randomized Clinical Trial)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PICO P- Horizontal deficient alveolar ridge in Anterior Maxillary Region I- Computer guided surgical cutting guide C- Conventional alveolar ridge splitting O- Clinical outcome and radiographic outcomes Primary outcome: Accuracy In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting.
In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm) Secondary outcome: Thickness of buccal cortical plate In both technique CBCT will performed and measuring the Both Buccal and palatal cortical bone in millimeter(mm)
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Partial edentulous in the aesthetic zone.
- Patient with bucco-lingual bone width is 3 mm or greater but < 6mm
- Normal alveolar bone height
- Adequate oral hygiene
- Free of soft tissue or dental pathology
- Patients accepting to participate in the study
Exclusion Criteria:
- Patient medically compromised.
- Uncooperative patient.
- Poor oral hygiene and periodontal disease.
- Patients who smoked and pregnant women
- Systemic disease directly affecting bone healing
- Atrophic ridges (1.5 mm or less)
- History of radiotherapy & treatment with bisphosphonates.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: computer guided
Group (A): comprised 6 patient undergoing surgical alveolar ridge splitting using computer guided surgical cutting stent. . |
comprised 6 patient undergoing surgical alveolar ridge splitting using computer guided surgical cutting stent
|
|
Aktiv komparator: conventional
Group (B) comprised 6 patient undergoing surgical alveolar ridge splitting using conventional technique
|
comprised 6 patient undergoing surgical alveolar ridge splitting using conventional technique.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy
Tidsramme: up to 4 months
|
In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting. In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm) In computer Guided: CBCT will performed pre-operative and post-operative for measure the difference of degree in superimposition after ridge splitting. In conventional method: Ridge mapping will applied in preoperative clinical evaluation, and measure in post-operative, the difference in splitting will calculate in millimeter (mm) |
up to 4 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Thickness of buccal cortical plate
Tidsramme: up to 4 months
|
In both technique CBCT will performed and measuring the Both Buccal and palatal cortical bone in millimeter(mm)
|
up to 4 months
|
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
- 152018
Plan for individuelle deltagerdata (IPD)
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