Inflammatory ResponseNCT06395116
Microbial Adhesion and Biofilm Formation on Denture Base Materials
An observational study of Inflammatory Response and Microbial Colonization, run by Menoufia University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response, Microbial Colonization, Denture Stomatitis
- What is being tested?
- Denture base material
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2023to 5 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Completely edentulous population who attended at the faculty of Dentistry, Menoufia University
Who may be able to join
- Completely edentulous populations.
- Good physical and mental health.
- No systemic disease
Who cannot join
- Partially edentulous populations.
- Patients with smoking more than 10 citrates day.
- Patients with systemic diseases.
- Patients undergrown radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
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.
- Being tested
- Denture base material
- Keywords
- Microbial adhesion, Biofilm formation, Denture base
- Medical subject headings
- Communicable Diseases, Stomatitis, Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denture base materialOther
Denture base material constructed with different techniques for completely edentulous populations
| Study group | Role | What they receive |
|---|---|---|
| Conventionl self cure acrylic group | Constructed from heat cured acrylic resin Receives: Other: Denture base material | |
| 3D printed acrylis resin group | Manufactured by additive manufacturing technique Receives: Other: Denture base material | |
| Milled acrylic resin group | Manufactured by milled technique Receives: Other: Denture base material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biofilm formation
such as Candida Albian's and Staphylococcus Aureus colonies per ml
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start20 Jan 2023
- Primary completion4 Jul 2024 (estimated)
- Study completion5 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University, Misr University for Science and Technology
- Responsible party
- Principal investigator, Mohammed Elsawy, Menoufia University
- Investigators
- Mohammed A. El-Sawy, PhD, Study director, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395116
- Sponsor's protocol ID
- R-RP-1-24-3091
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only with permission from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Influence of Fabrication Technique on Microbial Adhesion and Biofilm Formation to Conventional, Milled, and 3D-Printed Resin Denture Base Materials
- ClinicalTrials.gov ID
- NCT06395116
- Acronym / sponsor ID
- R-RP-1-24-3091
- Keywords
- Microbial adhesion, Biofilm formation, Denture base
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Tanta University, Misr University for Science and Technology
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 4 Jul 2024 (estimated)
- Study completion
- 5 Sep 2024 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventionl self cure acrylic group | – | Other: Denture base materialConstructed from heat cured acrylic resin |
| 3D printed acrylis resin group | – | Other: Denture base materialManufactured by additive manufacturing technique |
| Milled acrylic resin group | – | Other: Denture base materialManufactured by milled technique |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Completely edentulous population who attended at the faculty of Dentistry, Menoufia University
Key inclusion criteria (3 listed)
- Completely edentulous populations.
- Good physical and mental health.
- No systemic disease
Key exclusion criteria (4 listed)
- Partially edentulous populations.
- Patients with smoking more than 10 citrates day.
- Patients with systemic diseases.
- Patients undergrown radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denture base materialDenture base material constructed with different techniques for completely edentulous populations | Other | 3D printed acrylis resin group, Conventionl self cure acrylic group, Milled acrylic resin group |
Primary outcome
Biofilm formation
Time frame: 3 years
such as Candida Albian's and Staphylococcus Aureus colonies per ml
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No. Only with permission from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed A. El-Sawy, PhD study director
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Response and Microbial Colonization, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biofilm formation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.