Microbial Adhesion and Biofilm Formation on Denture Base Materials

Inflammatory Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06395116
• Other study ID #: R-RP-1-24-3091
• Status: Active, not recruiting
• Start date: January 20, 2023
• Est. completion date: September 5, 2024

Study information

• Verified date: April 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 5, 2024
• Est. primary completion date: July 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Denture Stomatitis
• Infections
• Inflammatory Response
• Microbial Colonization
• Stomatitis
• Stomatitis, Denture
• Tissue Adhesions

Intervention

Other:
• Denture base material
Denture base material constructed with different techniques for completely edentulous populations

Locations

Country	Name	City	State
Egypt	Mohammed A. El-Sawy	Mansoura

Sponsors (3)

Lead Sponsor	Collaborator
Menoufia University	Misr University for Science and Technology, Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biofilm formation	such as Candida Albian's and Staphylococcus Aureus colonies per ml	3 years