Conventional Versus Digital 3D Printed Complete Removable Dentures

Not Applicable

Recruiting

• Conditions: Denture, Complete
• Interventions: Device: Polymethyl Methacrylate-Based Complete Removable Dentures.; Device: Photopolymerized Methacrylate- Based Complete Removable Dentures.

• Registration Number: NCT05845099
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-05-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Polymethyl Methacrylate-Based Complete Removable Dentures.	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
Photopolymerized Methacrylate- Based Complete Removable Dentures.	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).

Primary Outcome Measures

Name	Time	Method
Assessment of oral microorganism proliferation by talking swab from	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of patients' satisfaction with both types of the Complete Removable Dentures	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)

Trial Locations

Locations (1)

Faculty of Dentistry, Ain shams University; 🇪🇬 Cairo, Egypt