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Active, not recruitingNCT06395116Updated May 1, 2024

Microbial Adhesion and Biofilm Formation on Denture Base Materials

An observational study in Inflammatory Response, Microbial Colonization and Denture Stomatitis, sponsored by Menoufia University. Active, not recruiting at 1 site in Egypt. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-01.

Sponsored by Menoufia University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 3 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
30 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Inflammatory Response
  • Microbial Colonization
  • Denture Stomatitis

Keywords

  • Microbial adhesion, Biofilm formation, Denture base
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's planned enrollment of 60 is below the median of 244 across 1,499 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Partially edentulous populations.
  • Patients with smoking more than 10 citrates day.
  • Patients with systemic diseases.
  • Patients undergrown radiotherapy.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Conventionl self cure acrylic group

    Constructed from heat cured acrylic resin

    Other: Denture base material

  • 3D printed acrylis resin group

    Manufactured by additive manufacturing technique

    Other: Denture base material

  • Milled acrylic resin group

    Manufactured by milled technique

    Other: Denture base material

Interventions

  • OtherDenture base material

    Denture base material constructed with different techniques for completely edentulous populations

06

What researchers measure

Primary outcomes

  1. Biofilm formation

    such as Candida Albian's and Staphylococcus Aureus colonies per ml

    Time frame: 3 years

07

Study locations

1 site
  • Mohammed A. El-Sawy
    Mansoura, 12345, Egypt
08

References and documents

Individual participant data

Plan to share: No — Only with permission from the corresponding author

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06395116
Lead sponsor
Menoufia University
Collaborators
Tanta University, Misr University for Science and Technology
Responsible party
Mohammed Elsawy (lecturer, Department of prosthodontics, principle investigator, Menoufia University) — Principal investigator
First posted
May 1, 2024
Start date
Jan 20, 2023
Primary completion
Jul 4, 2024 (estimated)
Completion
Sep 5, 2024 (estimated)
Last update
May 1, 2024

Study contacts

Mohammed A. El-Sawy, PhD
study director · Menoufia University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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