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M

Mansoura University

Status and phase

Invitation-only
Phase 3
Phase 2

Conditions

Digital Intervention

Treatments

Device: Implant supported prosthesis

Study type

Interventional

Funder types

Other

Identifiers

NCT07091786
J0204023RP

Details and patient eligibility

About

This study will aim to clinical evaluation of titanium-zirconium and peek-composite of screw retained prosthesis used for rehabilitation of edentulous patients using Complete digital workflow for construction of full arch implant supported screw retained restoration.

Enrollment

15 estimated patients

Sex

All

Ages

45 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • i- Edentulous jaws ii- Good oral hygiene and good compliance. iii- Angel's class I maxillo-mandibular relationship and a minimum of 16mm mandibular restorative space at the estimated occlusal vertical dimension. This will be verified by recoding a tentative jaw relation iv- Adequate bone height and width for placement of standard diameter implants. A cone beam computerized tomographic scan will be taken prior to surgery to determine the bone quality and bone volume

Exclusion Criteria:i- Systemic disease: uncontrolled diabetes mellitus, cardiovascular disease, immunodeficiency disorders, blood disorders such as coagulation disorders, severe osteoporosis, and any metabolic disease that might influence the rate of bone resorption ii- Long-term medication use: steroid, anti-epileptic drugs, drugs favoring gingival overgrowth, bispho- sphonates (bisphosphonate injections or more than 4 years of oral bisphosphonate use), and any medi- cation that influences the rate of bone loss or sur- vival of dental implants. iii- Infection of human immunodeficiency virus, hepatitis B virus, or syphilis iv- Bruxism v- Maxillofacial tumor

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

15 participants in 2 patient groups

group1
Active Comparator group
Description:
• the titanium group involved patients who will be received ISFCDs with individual zirconium veneers
Treatment:
Device: Implant supported prosthesis
group 2
Active Comparator group
Description:
The PEEK group included patients who will be received ISFCDs with individual PMMA composite veneers cemented onto a CAD-CAM PEEK framework
Treatment:
Device: Implant supported prosthesis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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