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

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT06111391

Collaborator

(none)

Enrollment

Location

Arms

11.6

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction Prosthetic Complication Clinical Outcomes	Device: Osstell® device (Integration Diagnostics Ltd.).	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 15, 2022

Actual Primary Completion Date :

Mar 12, 2023

Actual Study Completion Date :

Apr 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: maxillary titanium zirconium full arch fixed prosthesis maxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture.	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.).
Active Comparator: maxillary peek composite full arch fixed prosthesis maxillary peek composite full arch fixed prosthesis and mandibular distal extension partial denture.	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.).

Arm

Intervention/Treatment

Active Comparator: maxillary titanium zirconium full arch fixed prosthesis

maxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture.

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.).

Active Comparator: maxillary peek composite full arch fixed prosthesis

maxillary peek composite full arch fixed prosthesis and mandibular distal extension partial denture.

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

Outcome Measures

Primary Outcome Measures

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.).

Eligibility Criteria

Criteria

Ages Eligible for Study:

58 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura university	Mansoura		Egypt	35516

Sponsors and Collaborators

Mansoura University

Investigators

Study Director: Marwa Aboelez, Phd, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Mansoura University

ClinicalTrials.gov Identifier:

NCT06111391

Other Study ID Numbers:

A27080622

First Posted:

Nov 1, 2023

Last Update Posted:

Nov 1, 2023

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 1, 2023