Conventional Versus Digital 3D Printed Complete Removable Dentures

Denture, Complete Clinical Trial

— CRD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05845099
• Other study ID #: FDASU-Re IR112224
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: Omnia MS Refai, PHD
• Phone: +201202420046
• Email: omnia_refaie[@]dent.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Denture, Complete

Intervention

Device:
• Polymethyl Methacrylate-Based Complete Removable Dentures.
The patients will receive Complete Removable Dentures processed by Heat cured acrylic resin.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Ain shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Baba NZ, AlRumaih HS, Goodacre BJ, Goodacre CJ. Current techniques in CAD/CAM denture fabrication. Gen Dent. 2016 Nov-Dec;64(6):23-28. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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