NCT05845099

Conventional Versus Digital 3D Printed Complete Removable Dentures

Assessment of Microbial Adherence and Patients' Satisfaction in Conventional and Digital 3D Printed Complete Removable Dentures: A Cross Over Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Male
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The study is a crossover, randomised, controlled clinical trial that will compare and evaluate patients' satisfaction and oral microbiota proliferation in two groups. Group I: Conventionally manufactured CRD Group II: 3D-printed (three-dimensionally printed) CAD/CAM (computer-aided design/computer-aided manufacturing) manufactured CRD, The participants will be selected according to inclusion and exclusion criteria and will be randomly allocated into both groups and then shuffled to the other group using the Research Randomizer Program.

Detailed description

The study will be performed at the outpatient clinic of the Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University. Eleven edentulous male patients will be selected and recruited for this clinical trial after the informed consent provided by Faculty of Dentistry Ain Shams University-Research Ethics Committee (FDASU-REC) is assigned. They will be rehabilitated with Conventional and 3D-printed CAD-CAM (computer-aided design/computer-aided manufacturing) CRD. Participants will be randomly assigned to receive either Conventional or 3D-Printed CAD/CAM-manufactured CRD for three months before crossing over to the other set. care provider , investigator and participants will be blinded to the group allocation. Outcomes will be evaluated, including patient satisfaction with dentures and oral microbial adherence. The outcomes will be measured at baseline and at 1 and 3 months. The obtained data will be recorded, tabulated, and statistically analyzed using the appropriate tests for comparison between each group.

Conditions

• Denture, Complete

Interventions

Type	Name	Description
DEVICE	Polymethyl Methacrylate-Based Complete Removable Dentures.	The patients will receive Complete Removable Dentures processed by Heat cured acrylic resin.
DEVICE	Photopolymerized Methacrylate- Based Complete Removable Dentures.	The patients will receive a 3D-printed removable denture digitally manufactured using a 3d printer device with light polymerized resin.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-03-01
• Completion: 2024-05-01
• First posted: 2023-05-06
• Last updated: 2024-09-05

Locations

1 site across 1 country: Egypt