Conventional Versus 3D Printing Duplication Techniques of Complete Denture

NCT ID: NCT06588140

Last Updated: 2025-03-06

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

2024-09-01

Study Completion Date

2024-11-01

Brief Summary

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Twenty completely edentulous patients with old, removable dentures with ill-fitting maxillary dentures, proper vertical dimension, and proper occlusion will be recruited for this trial. They will be rehabilitated with duplicated complete dentures manufactured by conventional and two different 3D-printed CAD-CAM Complete Removable Dentures techniques.

Outcomes will be evaluated, including denture retention, which will be evaluated using a digital force gauge, and occlusal force distribution by using a t-scan.

Detailed Description

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The study will be conducted at the outpatient clinic of the Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University. This within-subject controlled clinical trial will involve twenty completely edentulous patients with old, ill-fitting maxillary complete dentures, who will be selected and recruited following approval by the Research Ethics Committee of the Faculty of Dentistry, Ain Shams University (FDASU-REC). These patients will be rehabilitated with duplicated complete dentures produced through conventional methods and two distinct 3D-printed CAD/CAM techniques.

Group I: The duplication of a refitted complete removable denture will be performed using the conventional heat-cured technique.

Group II: The refitted complete denture will be duplicated using a 3D-printed CAD/CAM technique, where the denture base will be printed separately with pink resin, and the teeth will be printed as a single unit in tooth-colored resin, followed by assembly of the two components.

Group III: The refitted complete denture will be duplicated using a 3D-printed CAD/CAM technique, with the entire denture printed as a single unit in tooth-colored resin, and the denture flange veneered with pink resin.

Outcomes will be evaluated by measuring denture retention with a digital force gauge and occlusal force distribution using the T-Scan system. The collected data will be recorded, tabulated, and subjected to statistical analysis using appropriate tests for group comparisons.

Conditions

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Denture,Complete Edentulous Alveolar Ridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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conventional heat-cured duplication technique.

Duplication of refitted complete removable dentures by conventional heat-cured technique from heat-cured polymethyl methacrylate resin.

Group Type ACTIVE_COMPARATOR

Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate.

Intervention Type DEVICE

The duplication of a refitted complete removable denture will be performed using conventional heat-cured polymethyl methacrylate through the conventional heat-cured polymerization technique.

3d Printed CAD/CAM duplication technique from Pink polymethyl methacrylate base resin

Duplication of a refitted complete removable denture will be produced using a 3D-printed CAD/CAM technique where the denture base will be printed separately using pink base polymethyl methacrylate resin, and the teeth will be printed as one unit using tooth-colored resin, followed by assembling the two components.

Group Type EXPERIMENTAL

Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin.

Intervention Type DEVICE

The duplication of a refitted complete removable denture will be performed using a 3D-printed CAD/CAM technique, where the denture base is printed separately with pink polymethyl methacrylate resin, and the teeth are printed as a single unit using tooth-colored resin, followed by the assembly of the two components.

3d Printed CAD/CAM duplication technique from white polymethyl methacrylate base resin

Duplication of a refitted complete removable denture will be produced using a 3D-printed CAD/CAM technique where the denture will be printed as a single unit using tooth-colored resin, and the denture flange will be veneered with pink resin.

Group Type EXPERIMENTAL

Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin.

Intervention Type DEVICE

The duplication of a refitted complete removable denture will be performed using a 3D-printed CAD/CAM technique, where the denture base is printed as a single unit using tooth-colored resin, and the denture flange will be veneered with pink polymethyl methacrylate resin.

Interventions

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Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate.

The duplication of a refitted complete removable denture will be performed using conventional heat-cured polymethyl methacrylate through the conventional heat-cured polymerization technique.

Intervention Type DEVICE

Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin.

The duplication of a refitted complete removable denture will be performed using a 3D-printed CAD/CAM technique, where the denture base is printed separately with pink polymethyl methacrylate resin, and the teeth are printed as a single unit using tooth-colored resin, followed by the assembly of the two components.

Intervention Type DEVICE

Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin.

The duplication of a refitted complete removable denture will be performed using a 3D-printed CAD/CAM technique, where the denture base is printed as a single unit using tooth-colored resin, and the denture flange will be veneered with pink polymethyl methacrylate resin.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with old complete dentures without lost vertical dimension.
2. Patients with correct centric occluding relation.
3. The dentures should be esthetically and functionally satisfactory and exhibit reasonable retention and stability

Exclusion Criteria

1. The presence of ridge or soft tissue pathology.
2. Diminished saliva production.
3. A history of medications affecting saliva quantity or quality.
4. Patients with temporomandibular joint problems.
5. The presence of sever ridge undercut.
6. Debilitated patients
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Omnia M. Refai

Lecturer of Oral and Maxillofacial Prosthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amany M Saad Farahat, PHD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams Univeristy

Yasmine S Elsherbeeny, PHD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams Univeristy

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FDASU-Rec IR032421

Identifier Type: -

Identifier Source: org_study_id

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