Skip to main content
OpenTrials
Completed

NCT Number: NCT06921577

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Denture Stomatitis Mouth Diseases Stomatitis Stomatitis, Denture Stomatognathic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry Tanta university Egypt

Tanta, Egypt

About this study

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:

  • Microbial colonization.
  • Patient satisfaction.

The following steps will be carried out for all patients:

  • Conventional primary and final impressions will be made for each patient
  • Master casts (upper and lower) and occlusion blocks will be scanned by an extra-oral scanner.
  • 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
  • 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.
  • For Group II, Pink denture base resin reinforced by Nanoparticles (ZrO2) will be used to print denture bases.
  • For Group Ш, Pink denture base resin reinforced by Nanoparticles (TiO2) will be used to print denture bases.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antimicrobial agent

Combination Product

Adding nanoparticles to 3Dprinted denture base resin improve the properties of the material

Other names: antimcrobial ffect

Primary outcomes

  1. Antimicrobial effect

    Time frame: 18 months

    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.

  2. Patient satisfaction

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Microbial and Laboratory Study of 3D Printed Reinforced Acrylic Denture

Acronym: dimensions

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.