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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polymethyl Methacrylate-Based Complete Removable Dentures. | Active Comparator | The patient will be provided by a CRD to restore his missing teeth which will be manufactured by heat curing processing technique |
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| Photopolymerized Methacrylate- Based Complete Removable Dentures. | Experimental | The patient will be provided by a CRD to restore his missing teeth which will be manufactured by 3D-printed (Digital Light Processing). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymethyl Methacrylate-Based Complete Removable Dentures. | Device | The patients will receive Complete Removable Dentures processed by Heat cured acrylic resin. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of oral microorganism proliferation by talking swab from | Assessment of oral microorganism proliferation by talking swab from the internal surface of both types of CRD to asses the affinity of oral microorganisms. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of patients' satisfaction with both types of the Complete Removable Dentures | 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) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
This study will include male patients only as old female patients can suffer from menopause and decreased immunity
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| Name | Affiliation | Role |
|---|---|---|
| Omnia MS Refai, PHD | lecturer of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry , Ain Shams University | Study Chair |
| Heba RF Elsarrif, PHD | Lecturer of Oral and Maxillofacial Prosthodontics College of oral and dental surgery Misr University for science and technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Ain shams University | Cairo | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34637889 | Background | Srinivasan M, Kalberer N, Fankhauser N, Naharro M, Maniewicz S, Muller F. CAD-CAM complete removable dental prostheses: A double-blind, randomized, crossover clinical trial evaluating milled and 3D-printed dentures. J Dent. 2021 Dec;115:103842. doi: 10.1016/j.jdent.2021.103842. Epub 2021 Oct 9. | |
| 27814252 | Background |
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double blind single center crossover design
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neither the patients nor the operator know which type of denture will be inserted
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| Photopolymerized Methacrylate- Based Complete Removable Dentures. | Device | The patients will receive a 3D-printed removable denture digitally manufactured using a 3d printer device with light polymerized resin. |
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| Baba NZ, AlRumaih HS, Goodacre BJ, Goodacre CJ. Current techniques in CAD/CAM denture fabrication. Gen Dent. 2016 Nov-Dec;64(6):23-28. |