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Clinical Trials/NCT06111391
NCT06111391CompletedNot Applicable

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

Mansoura University1 site in 1 country30 target enrollmentStarted: April 15, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
implant stability

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
58 Years to 68 Years (Adult, Older Adult)
Sex
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).

Arms & Interventions

maxillary titanium zirconium full arch fixed prosthesis

Active Comparator

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

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

maxillary peek composite full arch fixed prosthesis

Active Comparator

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

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

Outcomes

Primary Outcomes

implant stability

Time Frame: 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.).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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