Faculty of Dentistry, Ain shams University
Cairo, 11566, Egypt
NCT Number: NCT05845099
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.
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Notify Me45 year–60 year
Male
Interventional
Not applicable
Cairo, 11566, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patients will receive Complete Removable Dentures processed by Heat cured acrylic resin.
Other names: Complete Removable Denture manufacturing
The patients will receive a 3D-printed removable denture digitally manufactured using a 3d printer device with light polymerized resin.
Other names: 3D printed Removable Denture manufacturing
Time frame: 3 months
Assessment of oral microorganism proliferation by talking swab from the internal surface of both types of CRD to asses the affinity of oral microorganisms.
Time frame: 3 months
Evaluation of patients' satisfaction with both types of the Complete Removable Dentures by using Patient's Denture Assessment questionnaire (PDA) and interpreting it by using Likert scale (higher score (scale no.5) indicates good outcome and lower score (scale no.1)indicates bad outcome)
Ain Shams University
Other
Assessment of Microbial Adherence and Patients' Satisfaction in Conventional and Digital 3D Printed Complete Removable Dentures: A Cross Over Randomized Controlled Clinical Trial
Acronym: CRD
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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