- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06588140
Conventional Versus 3D Printing Duplication Techniques of Complete Denture
Comparison of Retention Between Different Duplication Techniques of Complete Dentures: Conventional Versus CAD/CAM: A Within Subject Controlled Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Device: Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate.
- Device: Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin.
- Device: Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin.
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 12345
- Ain Shams University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: conventional heat-cured duplication technique.
Duplication of refitted complete removable dentures by conventional heat-cured technique from heat-cured polymethyl methacrylate resin.
|
The duplication of a refitted complete removable denture will be performed using conventional heat-cured polymethyl methacrylate through the conventional heat-cured polymerization technique.
|
|
Experimental: 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.
|
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.
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at the time of denture insertion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at the time of denture insertion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amany M Saad Farahat, PHD, Ain Shams Univeristy
- Principal Investigator: Yasmine S Elsherbeeny, PHD, Ain Shams Univeristy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDASU-Rec IR032421
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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