Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations

Not Applicable

• Conditions: Completely Edentulous Patients
• Interventions: Procedure: No framework; Procedure: Fiber-reinforced framework

• Registration Number: NCT03814070
• Lead Sponsor: Nermeen Ahmed Hassan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-22
• Last Update Submitted: 2019-01-22
• Study First Posted: 2019-01-23
• Last Update Posted: 2019-01-23
• Study Start: 2019-02
• Primary Completion: 2019-10
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-reinforced full arch acrylic restorations	No framework	-
full arch acrylic restorations with fiber-reinforced framework	Fiber-reinforced framework	-

Primary Outcome Measures

Name	Time	Method
Prosthesis survival	4 months	Clinical evaluation of any fracture in the prosthesis

Secondary Outcome Measures

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