Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2020-03-31

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.

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Detailed Description

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Conditions

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Completely Edentulous Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-reinforced full arch acrylic restorations

Group Type ACTIVE_COMPARATOR

No framework

Intervention Type PROCEDURE

Non-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments.

full arch acrylic restorations with fiber-reinforced framework

Group Type EXPERIMENTAL

Fiber-reinforced framework

Intervention Type PROCEDURE

Glass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations

Interventions

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Fiber-reinforced framework

Glass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations

Intervention Type PROCEDURE

No framework

Non-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments.

Intervention Type PROCEDURE

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes