Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations

January 22, 2019 updated by: Nermeen Ahmed Hassan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non-reinforced full arch acrylic restorations
Procedure: No framework
Non-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments.
Experimental: full arch acrylic restorations with fiber-reinforced framework
Procedure: Fiber-reinforced framework
Glass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthesis survival
Time Frame: 4 months
Clinical evaluation of any fracture in the prosthesis
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival
Time Frame: 4 months
Clinical evaluation of implant loss
4 months
Peri-implant crestal bone loss during healing
Time Frame: 4 months
Crestal bone loss around implants is to be measured using periapical x ray with parallel technique in millemeters
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nermeen Ahmed Hassan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2019

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

January 18, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nermeen Ahmed Hassan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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