Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations

NCT03814070 | Unknown

• 1 other identifier: Nermeen Ahmed Hassan
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Completely Edentulous Patients

Outcome Measures

Primary Outcomes (1)

• Prosthesis survival

  Clinical evaluation of any fracture in the prosthesis

  4 months

Secondary Outcomes (2)

• Implant survival

  4 months

• Peri-implant crestal bone loss during healing

  4 months

Study Arms (2)

Non-reinforced full arch acrylic restorations

ACTIVE COMPARATOR

Procedure: No framework

full arch acrylic restorations with fiber-reinforced framework

EXPERIMENTAL

Procedure: Fiber-reinforced framework

Interventions

Fiber-reinforced framework PROCEDURE

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

full arch acrylic restorations with fiber-reinforced framework

No framework PROCEDURE

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

Non-reinforced full arch acrylic restorations

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous patients.
• Patients with proper amount of attached gingiva (≥2 mm)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nermeen Ahmed Hassan: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: February 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: March 1, 2020
• Last Updated: January 23, 2019

Record last verified: 2019-01