Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631573
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Prosthetic Complications in Fixed All-On-Four Prosthesis Reinforced with Poly Ether Ether Ketone PEEK Versus Cobalt Chromium Co-Cr Framework
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prosthetic Complications in Fixed All-On-Four Prosthesis Reinforced with Poly Ether Ether Ketone PEEK Versus Cobalt Chromium Co-Cr Framework in Completely Edentulous Mandibular Arches Randomized Controlled Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prosthetic complication will be measured for all-on-four fixed prosthesis in the mandibular arch in completely edentulous patients
Detailed Description:
Four implants will be placed in the edentulous mandible following all on four surgical protocol After 3 months as a healing phase a definitive prosthesis will be fabricated after ensuring the complete osseointegration of all implants Provisional restorations will be removed and final impressions will be taken for each patient using addition silicon impression materials Framework will be constructed using either Cobalt Chromium Co-Cr or Poly Ether Ether Ketone PEEK according to the randomization process Jaw relation and try-in will be done to ensure the correct centric relation Final prosthesis is then screwed to the abutments and the screw hole channels are closed with composite resin restorations Occlusal adjustments will be done after the delivery and in the subsequent follow up visit Prosthetic complications primary outcome and biological considerations secondary outcome will be measured every 3 months along the follow up period which is one year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None