- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06395116
Microbial Adhesion and Biofilm Formation on Denture Base Materials
"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
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Mansoura, Egypt, 12345
- Mohammed A. El-Sawy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Study Director: Mohammed A. El-Sawy, PhD, Menoufia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-RP-1-24-3091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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