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

Not Applicable

Completed

• Conditions: Clinical Outcomes; Patient Satisfaction; Prosthetic Complication
• Interventions: Device: Osstell® device (Integration Diagnostics Ltd.).

• Registration Number: NCT06111391
• Lead Sponsor: Mansoura University

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

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-04-15
• Primary Completion: 2023-03-12
• Study Completion: 2023-04-02
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-26
• Last Update Submitted: 2023-10-26
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
maxillary titanium zirconium full arch fixed prosthesis	Osstell® device (Integration Diagnostics Ltd.).	maxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture.
maxillary peek composite full arch fixed prosthesis	Osstell® device (Integration Diagnostics Ltd.).	maxillary peek composite full arch fixed prosthesis and mandibular distal extension partial denture.

Primary Outcome Measures

Name	Time	Method
implant stability	12 months	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.).

Trial Locations

Locations (1)

Mansoura university; 🇪🇬 Mansoura, Egypt