Patient Satisfaction , Prosthetic Complications and Clinical Outcomes of PEEK Composite Versus Titanium Zirconium

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate patient satisfaction (VAS) , prosthetic outcomes and clinical outcomes of polyether ether ketone (PEEK) Versus Titanium Zirconium fixed prostheses supported by six maxillary implants and opposed by distal extension removable partial denture.

Detailed Description
-----------------
thirty patients were selected for this study from a previous study who have already received previous implants in the maxillary arch. The patients were divided into two groups: Group1 received maxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture, Group 2 received maxillary PEEK composite full arch fixed prosthesis and mandibular distal extension partial denture Patient satisfaction was evaluated using visual analogue scale (VAS) after one year months , Prosthetic complications were measured on the patient and implant levels after one year

Official Title
-----------------
Patient Satisfaction , Prosthetic Complication and Clinical Outcomes of PEEK Composite Versus Titanium Zirconium Maxillary Fixed Full Arch Prosthetic Opposing Mandibular Distal Extension Partial Denture

Conditions
-----------------
Patient Satisfaction, Prosthetic Complication, Clinical Outcomes

Intervention / Treatment
-----------------
* Device: Osstell® device (Integration Diagnostics Ltd.).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal jaw relation Good oral hygiene Patient with class I or class II inter-rach space in order to have sufficient restoration space to construct FP3 prosthesis. Exclusion Criteria: Patients with TMJ disorder and heavy smokers for more than 10 cigarettes per day. Uncooperative patient. Unfavorable occlusion. Limited restoration space (less than 12 mm).

Ages Eligible for Study
-----------------
Minimum Age: 58 Years
Maximum Age: 68 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: maxillary titanium zirconium full arch fixed prosthesis<br>maxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture. | Device: Osstell® device (Integration Diagnostics Ltd.).<br>* After trans-mucosal abutments were removed and the smart pegs were attached to the fixtures, resonance frequency analysis was done to assess implant stability.The implant stability quotient (ISQ) was used to quantify stability via the Osstell® device (Integration Diagnostics Ltd.).<br>|
| Active Comparator: maxillary peek composite full arch fixed prosthesis<br>maxillary peek composite full arch fixed prosthesis and mandibular distal extension partial denture. | Device: Osstell® device (Integration Diagnostics Ltd.).<br>* After trans-mucosal abutments were removed and the smart pegs were attached to the fixtures, resonance frequency analysis was done to assess implant stability.The implant stability quotient (ISQ) was used to quantify stability via the Osstell® device (Integration Diagnostics Ltd.).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant stability | After transmucosal abutments were removed and the smart pegs were attached to the fixtures, resonance frequency analysis was done to assess implant stability.The implant stability quotient (ISQ) was used to quantify stability via the Osstell® device (Integration Diagnostics Ltd.). | 12 months |