Conventional Versus Digital 3D Printed Complete Removable Dentures (CRD)

September 2, 2024 updated by: Omnia M Refai, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Faculty of dentistry, ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Device: Polymethyl Methacrylate-Based Complete Removable Dentures.
The patients will receive Complete Removable Dentures processed by Heat cured acrylic resin.
Other Names:
  • Complete Removable Denture manufacturing
Experimental: 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).
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.
Other Names:
  • 3D printed Removable Denture manufacturing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of oral microorganism proliferation by talking swab from
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of patients' satisfaction with both types of the Complete Removable Dentures
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Omnia MS Refai, PHD, lecturer of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry , Ain Shams University
  • Study Director: Heba RF Elsarrif, PHD, Lecturer of Oral and Maxillofacial Prosthodontics College of oral and dental surgery Misr University for science and technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Estimated)

September 5, 2024

Last Update Submitted That Met QC Criteria

September 2, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDASU-Re IR112224

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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