Conventional Versus Digital 3D Printed Complete Removable Dentures

Ain Shams University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Denture, Complete

Interventions

Polymethyl Methacrylate-Based Complete Removable Dentures.DEVICE

The patients will receive Complete Removable Dentures processed by Heat cured acrylic resin.

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.

Eligibility

Sex: MALEMin age: 45 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who have been completely edentulous in both jaws (maxilla and mandible) for at least a year and require treatment with complete dentures. 2. The age of patients ranges from 45 to 60 years old. 3. Patients with a Class I maxillo-mandibular relationship. 4. Patients with adequate inter-arch space. 5. Patients with good neuromuscular control. 6. Patients without any temporomandibular joint disorder. Exclusion Criteria: 1. Patients with any oral diseases that may affect complete denture construction. 2. Patients with bad oral hygiene. 3. Patients with oral parafunctional habits. 4. Hysterical patients. 5. Patients will undergo or have previously received chemotherapy or radiotherapy. 6. Smokers or drug- addicted patients

Locations (1)

Faculty of Dentistry, Ain shams University

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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)

Time frame: 3 months

Data from ClinicalTrials.gov

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