Microbial Adhesion and Biofilm Formation on Denture Base Materials

NCT ID: NCT06395116

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-20

Study Completion Date

2024-09-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Inflammatory Response Microbial Colonization Denture Stomatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventionl self cure acrylic group

Constructed from heat cured acrylic resin

Denture base material

Intervention Type OTHER

Denture base material constructed with different techniques for completely edentulous populations

3D printed acrylis resin group

Manufactured by additive manufacturing technique

Denture base material

Intervention Type OTHER

Denture base material constructed with different techniques for completely edentulous populations

Milled acrylic resin group

Manufactured by milled technique

Denture base material

Intervention Type OTHER

Denture base material constructed with different techniques for completely edentulous populations

Interventions

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Denture base material

Denture base material constructed with different techniques for completely edentulous populations

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role collaborator

Misr University for Science and Technology

OTHER

Sponsor Role collaborator

Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Elsawy

lecturer, Department of prosthodontics, principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed A. El-Sawy, PhD

Role: STUDY_DIRECTOR

Menoufia University

Locations

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Mohammed A. El-Sawy

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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R-RP-1-24-3091

Identifier Type: -

Identifier Source: org_study_id

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