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

NCT06921577 | Completed DMC

• 1 other identifier: RP 2-23 1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Denture Stomatitis

Keywords

3Dprinted resin; nanoparticles; antimicrobial effect

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Nanoparticles

EXPERIMENTAL

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

Interventions

antimicrobial agent COMBINATION_PRODUCT

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

Also known as: antimcrobial ffect

Nanoparticles

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with any diseases that may affect denture construction
• Patients with oral parafunctional habits.
• Patients with tempromandibular disorders

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of dentistry Tanta university Egypt

Tanta, Egypt

Location

Related Publications (1)

• Ahmed Teama EM, Amin Rashad HM, Mohamed Shakal EAE, Hegazy EE. Clinical and microbial study of reinforced 3D-printed maxillary denture base resin: a randomized trial. BMC Oral Health. 2025 Jul 17;25(1):1192. doi: 10.1186/s12903-025-06601-2.

  PMID: 40676540 DERIVED

MeSH Terms

Conditions

Stomatitis, Denture

Interventions

Anti-Infective Agents

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Houda MA Rashad, professor

  Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturere in prosthodontics departement faculty of dentistry Tanta univrtsity

Model Details: This study aimed to compare the effects of adding nanoZrO2 (0.4% wt) and nanoTiO2 (0.4% wt) to 3D-printed acrylic resin dentures in complete edentulous patients on microbial colonization and patient satisfaction.

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 10, 2025
• Study Start: February 10, 2023
• Primary Completion: July 20, 2024
• Study Completion: August 10, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)