Conventional Versus Digital 3D Printed Complete Removable Dentures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-05-01

Brief Summary

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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.

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Detailed Description

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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

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Denture, Complete

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

double blind single center crossover design

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

neither the patients nor the operator know which type of denture will be inserted

Study Groups

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Polymethyl Methacrylate-Based Complete Removable Dentures.

The patient will be provided by a CRD to restore his missing teeth which will be manufactured by heat curing processing technique

Group Type ACTIVE_COMPARATOR

Polymethyl Methacrylate-Based Complete Removable Dentures.

Intervention Type DEVICE

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

Photopolymerized Methacrylate- Based Complete Removable Dentures.

The patient will be provided by a CRD to restore his missing teeth which will be manufactured by 3D-printed (Digital Light Processing).

Group Type EXPERIMENTAL

Photopolymerized Methacrylate- Based Complete Removable Dentures.

Intervention Type DEVICE

The patients will receive a 3D-printed removable denture digitally manufactured using a 3d printer device with light polymerized resin.

Interventions

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Polymethyl Methacrylate-Based Complete Removable Dentures.

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

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Complete Removable Denture manufacturing 3D printed Removable Denture manufacturing

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes