Clinical and Microbial Study of Reinforced 3D Printed Maxillary Denture Base Resin (dimensions)

Microbial and Laboratory Study of 3D Printed Reinforced Acrylic Denture

Statement of problem: 3D printed denture base resin is needed to reinforce Purpose: To evaluate the effects of adding nano-ZrO2 and nano-TiO2 on microbial colonization and patient satisfaction with 3D-printed maxillary complete dentures.

Materials and Methods: Twenty-four patients who needed complete dentures were randomly distributed into three equal groups. Group I: Patients used maxillary complete dentures 3D printed without additives. Group II: Patients used maxillary complete dentures 3D after reinforcement by Nano-ZrO2 (0.4%) by Wt. Group III: Patients used maxillary complete dentures 3D printed after reinforcement by Nano-TiO2 (0.4%) by Wt. For microbial evaluation, a cotton swab was taken from the mucosa and the intaglio surface of maxillary dentures, and microbial colonization was evaluated by calculating the number of colony-forming units of S. aureus on mannitol salt agar plates and C. albicans on Sabouraud's dextrose agar plates after 48 hours of incubation at insertion, 6 months, 12 months and 18 months. Patient satisfaction was evaluated 15 days after insertion and at 6, 12, and 18 months. The values of microbial colonization and patient satisfaction were analyzed via repeated-measures ANOVA followed by Tukey's multiple comparison test.

Study Overview

• Status: Completed
• Conditions: Denture Stomatitis
• Intervention / Treatment: Combination product: antimicrobial agent

Detailed Description

This study aims to compare the effect of 3D printed denture base without nanoparticles and 3D printed denture base reinforced with ZrO2 and TiO2 nanoparticles on completely edentulous patients, as regards:

1. Microbial colonization.
2. Patient satisfaction.

The following steps will be carried out for all patients:

1. Conventional primary and final impressions will be made for each patient
2. Master casts (upper and lower) and occlusion blocks will be scanned by an extra-oral scanner.
3. Files in standard tessellation language (STL) format of master casts and jaw relation records will be imported to the software platform. The software will enable virtually simultaneous mounting and aligning. Each denture will have two STL files that will be printed separately: one for the denture base and one for the teeth, using a 3D printer.29
4. For Group Ι, the designed dentures STL files will be sent to the 3D printer software. Pink denture base resin will be used to print denture bases without nanoparticles.
5. For Group II, Pink denture base resin reinforced by Nanoparticles (ZrO2) will be used to print denture bases.
6. For Group Ш, Pink denture base resin reinforced by Nanoparticles (TiO2) will be used to print denture bases.
7. White teeth resin will be utilized for teeth printing for all groups. Finally, teeth will be attached to recessed pockets in the dentures bases via resin. Followed by finishing. Eventually, dentures will be placed in the post-curing unit.

All patients will be given similar post insertion instructions and a regular oral and denture hygiene protocol.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Faculty of dentistry Tanta university Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Completely edentulous patients with good local and systemic health.
• Patients' ages range from 50 to 70 years old.
• Must have adequate interarch space and class Ⅰ angle classification.
• Must have a reasonable neuromuscular control. Patient exclusion criteria
• Patients with any diseases that may affect denture construction
• Patients with oral parafunctional habits.
• Patients with tempromandibular disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nanoparticles; Group II: Patients used maxillary complete dentures 3D after reinforcement by Nano-ZrO2 (0.4%) by Wt. Group III: Patients used maxillary complete dentures 3D printed after reinforcement by Nano-TiO2 (0.4%) by Wt	Combination product: antimicrobial agent; Adding nanoparticles to 3Dprinted denture base resin improve the properties of the material; Other Names: antimcrobial ffect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antimicrobial effect	Cotton swabs were taken from the mucosa and the intaglio surface of maxillary dentures, and microbial colonization was evaluated by calculating the number of colony-forming units of S. aureus on mannitol salt agar plates and C. albicans on Sabouraud's dextrose agar plates after 48 hours of incubation at insertion, 6 months, 12 months and 18 months.	18 months
Patient satisfaction	Patient satisfaction was evaluated 15 days after insertion and at 6, 12, and 18 months. Patients were requested to assess their overall satisfaction with their dentures through the visual analog scale. The patients were asked five questions: "How satisfied were you with your prosthesis considering aesthetics, speech, masticatory efficiency, hygiene, and comfort?" A ten-point scale was used to evaluate each question; the minimum score is zero, while the maximum score is ten. Higher scores mean a better outcome.	18 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Director: Houda MA Rashad, professor, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): July 20, 2024
• Study Completion (Actual): August 10, 2024

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: antimicrobial effect; nanoparticles; 3Dprinted resin
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatitis; Stomatitis, Denture; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: RP 2-23 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the guidelines of human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No