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Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations

Primary Purpose

Completely Edentulous Patients

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fiber-reinforced framework
No framework
Sponsored by
Nermeen Ahmed Hassan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Completely Edentulous Patients

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Non-reinforced full arch acrylic restorations

    full arch acrylic restorations with fiber-reinforced framework

    Arm Description

    Outcomes

    Primary Outcome Measures

    Prosthesis survival
    Clinical evaluation of any fracture in the prosthesis

    Secondary Outcome Measures

    Implant survival
    Clinical evaluation of implant loss
    Peri-implant crestal bone loss during healing
    Crestal bone loss around implants is to be measured using periapical x ray with parallel technique in millemeters

    Full Information

    First Posted
    January 18, 2019
    Last Updated
    January 22, 2019
    Sponsor
    Nermeen Ahmed Hassan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03814070
    Brief Title
    Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations
    Official Title
    Prosthesis and Implant Survival in Immediately Loaded Full Arch Restorations Using Fiber Reinforced Versus Non-reinforced Temporary Frameworks: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    October 2019 (Anticipated)
    Study Completion Date
    March 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nermeen Ahmed Hassan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Completely Edentulous Patients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    114 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-reinforced full arch acrylic restorations
    Arm Type
    Active Comparator
    Arm Title
    full arch acrylic restorations with fiber-reinforced framework
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Fiber-reinforced framework
    Intervention Description
    Glass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations
    Intervention Type
    Procedure
    Intervention Name(s)
    No framework
    Intervention Description
    Non-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments.
    Primary Outcome Measure Information:
    Title
    Prosthesis survival
    Description
    Clinical evaluation of any fracture in the prosthesis
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Implant survival
    Description
    Clinical evaluation of implant loss
    Time Frame
    4 months
    Title
    Peri-implant crestal bone loss during healing
    Description
    Crestal bone loss around implants is to be measured using periapical x ray with parallel technique in millemeters
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

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