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

NCT ID: NCT06111391

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2023-04-02

Brief Summary

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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

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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

Conditions

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Patient Satisfaction Prosthetic Complication Clinical Outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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maxillary titanium zirconium full arch fixed prosthesis

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

Group Type ACTIVE_COMPARATOR

Osstell® device (Integration Diagnostics Ltd.).

Intervention Type DEVICE

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.).

maxillary peek composite full arch fixed prosthesis

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

Group Type ACTIVE_COMPARATOR

Osstell® device (Integration Diagnostics Ltd.).

Intervention Type DEVICE

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.).

Interventions

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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.).

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

58 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marwa Aboelez, Phd

Role: STUDY_DIRECTOR

Mansoura University

Locations

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Mansoura university

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 34588401 (View on PubMed)

Other Identifiers

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A27080622

Identifier Type: -

Identifier Source: org_study_id

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