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NCT06111391 Clinical Trial

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

Patient Satisfaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06111391
Other study ID # A27080622
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2022
Est. completion date April 2, 2023

Study information
Verified date February 2022
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 2, 2023
Est. primary completion date March 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 58 Years to 68 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Osstell® device (Integration Diagnostics Ltd.).
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.).

Locations
Country Name City State
Egypt Mansoura university Mansoura

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Wang J, Wu P, Liu HL, Zhang L, Liu LP, Ma CF, Chen JH. Polyetheretherketone versus titanium CAD-CAM framework for implant-supported fixed complete dentures: a retrospective study with up to 5-year follow-up. J Prosthodont Res. 2022 Apr 27;66(2):279-287. doi: 10.2186/jpr.JPR_D_20_00142. Epub 2021 Sep 30. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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