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
About this trial
This is an interventional treatment trial for Completely Edentulous Patients
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
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
NCT ID
NCT03814070
First Posted
January 18, 2019
Last Updated
January 22, 2019
Sponsor
Nermeen Ahmed Hassan
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
Learn more about this trial
Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations
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