Effect of PEEK and Co-Cr Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles. A Randomized Controlled Clinial Trial

NCT ID: NCT06591611

Last Updated: 2024-09-19

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-03-30

Brief Summary

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A fixed all-on-four prosthesis will be fabricated for the mandibular arch for each patient and the marginal bone loss will be evaluated at baseline, 3,6,9 and 12 months

Detailed Description

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Conditions

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All on Four, Marginal Bone Loss, PEEK

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Co-Cr reinforced fixed all-on-four prosthesis

Group Type ACTIVE_COMPARATOR

PEEK reinforced fixed all-on-four prosthesis

Intervention Type OTHER

Fabricating a fixed prosthesis for patients with completely edentulous mandibles reinforced with PEEK

PEEK reinforced fixed all-on-four prosthesis

Group Type EXPERIMENTAL

PEEK reinforced fixed all-on-four prosthesis

Intervention Type OTHER

Fabricating a fixed prosthesis for patients with completely edentulous mandibles reinforced with PEEK

Interventions

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PEEK reinforced fixed all-on-four prosthesis

Fabricating a fixed prosthesis for patients with completely edentulous mandibles reinforced with PEEK

Intervention Type OTHER

Other Intervention Names

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Dental Prosthesis

Eligibility Criteria

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Inclusion Criteria

* Completely edentulous patient with old satisfactory maxillary and mandibular dentures requiring an implant supported restoration
* Implant sites must allow for implant placement
* Patients with no systemic conditions that may interfere with implant placement

Exclusion Criteria

* General contraindications for implant surgery( Poor oral hygiene- diabetes- pregnancy or nursing- drug abusers)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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shereen ismail

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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21223

Identifier Type: -

Identifier Source: org_study_id

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