Patient Satisfaction , Prosthetic Complications and Clinical Outcomes of PEEK Composite Versus Titanium Zirconium
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2023
CompletedFirst Submitted
Initial submission to the registry
October 20, 2023
CompletedFirst Posted
Study publicly available on registry
November 1, 2023
CompletedNovember 1, 2023
February 1, 2022
11 months
October 20, 2023
October 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
maxillary titanium zirconium full arch fixed prosthesis
ACTIVE COMPARATORmaxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture.
maxillary peek composite full arch fixed prosthesis
ACTIVE COMPARATORmaxillary peek composite full arch fixed prosthesis and mandibular distal extension partial denture.
Interventions
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.).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university
Al Mansurah, 35516, Egypt
Related 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.
PMID: 34588401BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marwa Aboelez, Phd
Mansoura University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2023
First Posted
November 1, 2023
Study Start
April 15, 2022
Primary Completion
March 12, 2023
Study Completion
April 2, 2023
Last Updated
November 1, 2023
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share