Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations

Completely Edentulous Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03814070
• Other study ID #: Nermeen Ahmed Hassan
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: March 2020

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: March 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Completely Edentulous Patients

Intervention

Procedure:
• Fiber-reinforced framework
Glass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations
• No framework
Non-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nermeen Ahmed Hassan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthesis survival	Clinical evaluation of any fracture in the prosthesis	4 months
Secondary	Implant survival	Clinical evaluation of implant loss	4 months
Secondary	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