Effect of Printing Layer Thickness on Growth of Candida Albicans in Completely Edentulous Patients Rehabilitated With 3D-Printed Maxillary Complete Denture Bases.

December 22, 2025 updated by: ahmed abdelgawad mousa, Cairo University

Effect of Printing Layer Thickness on Growth of Candida Albicans in Completely Edentulous Patients Rehabilitated With 3D-Printed Maxillary Complete Denture Bases: A Randomized Cross-over Study

In completely edentulous patients rehabilitated with 3D-printed maxillary dentures bases, does the printing layer thickness affect candidal adherence and growth on the fitting surface of dentures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The trial will follow a cross-over design, where each participant will wear denture bases printed with three different layer thicknesses (25 µm, 50 µm, and 100 µm) at a random order. Each participant will wear each of the three dentures for an 8-week period, with a washout period of two weeks between each thickness.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Completely edentulous patients aged 30-80 years
  • Oral cavity is free from any mucosal lesions.
  • No systemic conditions that would contraindicate participation in the study.

Exclusion Criteria:

  • History of allergic reactions to denture materials.
  • Active mucosal lesions related to denture use.
  • Pregnancy or lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Crossover Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Candidal growth
Time Frame: 8-10 weeks
candidal growth over denture surface measured by colony-forming units (CFU)
8-10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2026

Primary Completion (Estimated)

December 5, 2026

Study Completion (Estimated)

January 5, 2027

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3354445

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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