Accuracy of 3D Printed Complete Dentures Using Two Impression Techniques: RCT

NCT ID: NCT04982510

Last Updated: 2024-02-08

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

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-06-27

Brief Summary

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the aim of this crossover randomized controlled clinical trial is comparing retention of 3D printed maxillary complete dentures produced from thermoplastic impression trays and conventional acrylic impression trays.

The research hypothesis is that there is no difference in patient satisfaction and retention of dentures constructed from definitive impression using the conventional tray and the prefabricated thermoplastic tray

Detailed Description

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Conditions

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Edentulism Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Thermoplastic tray definitive impression

Group Type EXPERIMENTAL

complete denture

Intervention Type DEVICE

3D printed complete denture

Conventional tray definitive impression

Group Type ACTIVE_COMPARATOR

complete denture

Intervention Type DEVICE

3D printed complete denture

Interventions

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complete denture

3D printed complete denture

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male edentulous patients.
* Cooperative and highly motivated patients.
* Patients with well or moderately developed ridges and healthy attached mucosa of appropriate thickness free from inflammation

Exclusion Criteria

* Patients with recent extraction less than 3 months ago
* Patients with Parkinson's disease
* Patients with xerostomia.
* Patients with allergy to resins.
* Pathological changes of residual ridges.
* Patient with sever undercuts, or irregular bony exostosis.
* Patients with flabby and flat ridges.
* Patients with medical or psychological conditions that hinder co-operation.
* Patients with class II or III jaw relation.
Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sonal Abdelbaseer

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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4421

Identifier Type: -

Identifier Source: org_study_id

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