Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations

Study Overview
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Brief Summary
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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.

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

Conditions
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Completely Edentulous Patients

Intervention / Treatment
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* Procedure: Fiber-reinforced framework
* Procedure: No framework


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival | Clinical evaluation of implant loss | 4 months | 
| 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 | 4 months |