Microbial Adhesion and Biofilm Formation on Denture Base Materials

April 29, 2024 updated by: Mohammed Elsawy, Menoufia University

"Influence of Fabrication Technique on Microbial Adhesion and Biofilm Formation to Conventional, Milled, and 3D-Printed Resin Denture Base Materials

Polymethylmethacrylate (PMMA) has been the material of choice for fabricating complete dentures for more than 80 years now.(1,2) As a material it is easy to handle and can be easily repaired and polished. PMMA while being a low-cost material has good esthetics. Some disadvantages of PMMA as a material are surface roughness and porosities which lead to staining, plaque accumulation and bacterial adhesion over time.

Among the various factors that can influence microbial attachment to surfaces, surface roughness, hydrophilicity and free surface energy of PMMA are most important. Carboxylate and methyl ester groups found in PMMA make it a very hydrophilic material with a large amount of free surface energy. Despite the influence of the chemical composition, processing methods play the most important role in developing surface roughness.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

PMMA for dentures may be processed by conventional techniques like compression moulding or injection moulding with the conventional pack and press technique being considered the 'gold standard' when it comes to processing methods as it has successfully withstood the test of time. With the advent of technology CAD/CAM milling is now being used to mill dentures from pre-polymerized blocks of acrylic resin. At the same time 3D printing/Rapid prototyping technology is also being used to print denture bases with acrylic resins. Both these technologies eliminate the need for conventional flasking and processing methods. The rapid prototyping technique involves serial apposition of resin layers on a custom designed support structure. These layers are hardened by curing with either visible light, UV Light, heat or laser depending upon the technique used. This process is repeated until the designed structure is completely formed. The milling or subtractive technique on the other hand uses pre-polymerized commercially manufactured PMMA blanks (Pucks) which are made under high pressure. This technique allows for the material to have superior mechanical properties.

In reviewing the literature, no clinical studies were performed to compare which method of PMMA denture construction can reduce the amount of microbial colonization while there are a lot of invitro studies was performed.

Study Type

Observational

Enrollment (Estimated)

60

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

      • Mansoura, Egypt, 12345
        • Mohammed A. El-Sawy

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Completely edentulous population who attended at the faculty of Dentistry, Menoufia University

Description

Inclusion Criteria:

  • Completely edentulous populations.
  • Good physical and mental health.
  • No systemic disease

Exclusion Criteria:

  • Partially edentulous populations.
  • Patients with smoking more than 10 citrates day.
  • Patients with systemic diseases.
  • Patients undergrown radiotherapy.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conventionl self cure acrylic group
Constructed from heat cured acrylic resin
Denture base material constructed with different techniques for completely edentulous populations
3D printed acrylis resin group
Manufactured by additive manufacturing technique
Denture base material constructed with different techniques for completely edentulous populations
Milled acrylic resin group
Manufactured by milled technique
Denture base material constructed with different techniques for completely edentulous populations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biofilm formation
Time Frame: 3 years
such as Candida Albian's and Staphylococcus Aureus colonies per ml
3 years

Collaborators and Investigators

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

Investigators

  • Study Director: Mohammed A. El-Sawy, PhD, Menoufia 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 (Actual)

January 20, 2023

Primary Completion (Estimated)

July 4, 2024

Study Completion (Estimated)

September 5, 2024

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only with permission from the corresponding author

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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