Conventional Versus Digital 3D Printed Complete Removable Dentures

NCT05845099 | Completed DMC

• 1 other identifier: FDASU-Re IR112224
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Denture, Complete

Keywords

3D printing; CAD/CAM; Complete dentures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of patients' satisfaction with both types of the Complete Removable Dentures

  3 months

Study Arms (2)

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

Device: Polymethyl Methacrylate-Based Complete Removable Dentures.

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).

Device: Photopolymerized Methacrylate- Based Complete Removable Dentures.

Interventions

Polymethyl Methacrylate-Based Complete Removable Dentures. DEVICE

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

Also known as: Complete Removable Denture manufacturing

Polymethyl Methacrylate-Based Complete Removable Dentures.

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.

Also known as: 3D printed Removable Denture manufacturing

Photopolymerized Methacrylate- Based Complete Removable Dentures.

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: This study will include male patients only as old female patients can suffer from menopause and decreased immunity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who have been completely edentulous in both jaws (maxilla and mandible) for at least a year and require treatment with complete dentures.
• The age of patients ranges from 45 to 60 years old.
• Patients with a Class I maxillo-mandibular relationship.
• Patients with adequate inter-arch space.
• Patients with good neuromuscular control.
• Patients without any temporomandibular joint disorder.

You may not qualify if:

• Patients with any oral diseases that may affect complete denture construction.
• Patients with bad oral hygiene.
• Patients with oral parafunctional habits.
• Hysterical patients.
• Patients will undergo or have previously received chemotherapy or radiotherapy.
• Smokers or drug- addicted patients

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain shams University

Cairo, 11566, Egypt

Location

Related Publications (2)

• 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.

  PMID: 34637889 BACKGROUND

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

  PMID: 27814252 BACKGROUND

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: neither the patients nor the operator know which type of denture will be inserted
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral and Maxillofacial Prosthodontics

Model Details: double blind single center crossover design

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 6, 2023
• Study Start: December 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

EG (1)