Clinical trial NCT06588140: Conventional Versus 3D Printing Duplication Techniques of Complete Denture
Official title: Comparison of Retention Between Different Duplication Techniques of Complete Dentures: Conventional Versus CAD/CAM: A Within Subject Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Denture,Complete
Edentulous Alveolar Ridge
Keywords: CAD-CAM
Complete Dentures
Copying , Denture
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Retention of maxillary complete denture
timeFrame: at the time of denture insertion
Secondary outcomes:
measure: Evaluation of occlusal force distribution between right and left side
timeFrame: at the time of denture insertion
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams Univeristy
name: Amany M Saad Farahat, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams Univeristy
name: Yasmine S Elsherbeeny, PHD
role: PRINCIPAL_INVESTIGATOR
References: