To Evaluate the Complete Mandibular Dentures Produced Via 3D Printing in Comparison to Those Constructed From Metal-reinforced Acrylic Resin Regarding Their Retention

NCT ID: NCT07061860

Last Updated: 2025-07-18

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-07

Study Completion Date

2025-01-07

Brief Summary

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in this study we will construct denture for patient by different way and material one of this denture constructed digitally and the other one constructed in conventional way with metal reinforced. then we will measure the retention of the dentures

Detailed Description

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the complete denture is constructed for completely edentulous patient. the different technique of construction aim to increase retention of denture to prevent dislodgment during mastication

Conditions

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Edentulous Alveolar Ridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomozied controlled parallel double blinding study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
blinding to patient and operator in intervention from begining

Study Groups

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complete edentulous patient receive 3D printed denture

group 1: 10 patients: Complete dentures constructed from poly-methyl methacrylate resin were used to create the mandibular and maxillary 3D-printed dentures

Group Type EXPERIMENTAL

digital complete denture

Intervention Type DEVICE

different method of denture construction

complete edentulous patient receive metal reinforced denture

group 2: 10 patients: complete denture constructed from metal reinforced acrylic denture

Group Type ACTIVE_COMPARATOR

metal reinforced complete denture

Intervention Type DEVICE

different method of denture construction

Interventions

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digital complete denture

different method of denture construction

Intervention Type DEVICE

metal reinforced complete denture

different method of denture construction

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Class I maxillary-mandibular relationship
* well-maintained oral mucosa
* normal salivary flow

Exclusion Criteria

* smokers patient
* patient had any abnormalities in hard or soft tissues
* severe ridge undercut
* patient received radiation therapy to the head and neck region
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Ayman Fathy Farouk El-Awadi

assistant professor in Prosthodontics Department, Oral and Dental Research Institution, National Research Centre, Cairo, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman F Elawady, Ass prof

Role: PRINCIPAL_INVESTIGATOR

National research center, cairo, Egypt

Locations

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National Resaerch Center

Cairo, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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8887082022

Identifier Type: -

Identifier Source: org_study_id

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