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Clinical Trials/NCT03814070
NCT03814070
Unknown
Not Applicable

Prosthesis and Implant Survival in Immediately Loaded Full Arch Restorations Using Fiber Reinforced Versus Non-reinforced Temporary Frameworks: A Randomized Clinical Trial

Nermeen Ahmed Hassan0 sites114 target enrollmentFebruary 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Completely Edentulous Patients
Sponsor
Nermeen Ahmed Hassan
Enrollment
114
Primary Endpoint
Prosthesis survival
Last Updated
7 years ago

Overview

Brief Summary

In immediate loading of implants of completely edentulous patients, the most common post-surgical complication following the surgery noted in the dental literature is fracture of the provisional restoration with rates ranging from 4.17% to 41%. Most of these fractures occur because polymethyl methacrylate (PMMA) materials are inadequate and have low rigidity to withstand extended periods of heavy occlusal use.

Fractures of full arch provisional restorations during healing are concerning, because they eliminate cross-arch stabilization and disrupt stress distribution patterns which might jeopardize implant osseointegration affecting the survival rates for implants. Therefore, it is important to look for another material that has higher rigidity than PMMA and can withstand masticatory forces for extended periods without fractures or load concentration on the implants during the osseointegration period.

Registry
clinicaltrials.gov
Start Date
February 2019
End Date
March 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nermeen Ahmed Hassan
Responsible Party
Sponsor Investigator
Principal Investigator

Nermeen Ahmed Hassan

PhD candidate

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Completely edentulous patients.
  • Patients with proper amount of attached gingiva (≥2 mm)

Exclusion Criteria

  • Patients having a medical condition that absolutely contraindicates implant placement.
  • Patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin (HbA1c). (greater than 6.4 percent)
  • Potentially uncooperative patients who are not willing to go through the proposed interventions.
  • Moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day).
  • Patients with history of bruxism
  • If insertion torque for the implants is less than 35 Ncm

Outcomes

Primary Outcomes

Prosthesis survival

Time Frame: 4 months

Clinical evaluation of any fracture in the prosthesis

Secondary Outcomes

  • Peri-implant crestal bone loss during healing(4 months)
  • Implant survival(4 months)

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