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Completed

NCT Number: NCT06588140

Conventional Versus 3D Printing Duplication Techniques of Complete Denture

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.

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Key information

Conditions

Denture,Complete Edentulous Alveolar Ridge

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The presence of ridge or soft tissue pathology.
  • Diminished saliva production.
  • A history of medications affecting saliva quantity or quality.
  • Patients with temporomandibular joint problems.
  • The presence of sever ridge undercut.
  • Debilitated patients

Treatment and study plan

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

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.

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

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.

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

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.

Primary outcomes

  1. Assessment of Retention of maxillary complete denture

    Time frame: at the time of denture insertion

    The retention of a maxillary complete denture will be assessed using a digital force gauge meter, with retention measurements recorded in Newtons.

Secondary outcomes

  1. Evaluation of occlusal force distribution between right and left side

    Time frame: at the time of denture insertion

    Occlusal force distribution will be assessed using the T-Scan III, with the results expressed as a percentage.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Comparison of Retention Between Different Duplication Techniques of Complete Dentures: Conventional Versus CAD/CAM: A Within Subject Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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