Denture StomatitisdimensionsNCT06921577
Clinical and Microbial Study of Reinforced 3D Printed Maxillary Denture Base Resin
A study testing antimicrobial agent in people with Denture Stomatitis, run by Tanta University at 1 site in Egypt.
Trial summary
Statement of problem: 3D printed denture base resin is needed to reinforce Purpose: To evaluate the effects of adding nano-ZrO2 and nano-TiO2 on microbial colonization and patient satisfaction with 3D-printed maxillary complete dentures. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Denture Stomatitis
- What is being tested?
- antimicrobial agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2023to 10 Aug 2024
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous patients with good local and systemic health.
- Patients' ages range from 50 to 70 years old.
- Must have adequate interarch space and class Ⅰ angle classification.
- Must have a reasonable neuromuscular control. Patient exclusion criteria
- Patients with any diseases that may affect denture construction
- Patients with oral parafunctional habits.
- Patients with tempromandibular disorders
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbial and Laboratory Study of 3D Printed Reinforced Acrylic Denture
Statement of problem: 3D printed denture base resin is needed to reinforce Purpose: To evaluate the effects of adding nano-ZrO2 and nano-TiO2 on microbial colonization and patient satisfaction with 3D-printed maxillary complete dentures.
Materials and Methods: Twenty-four patients who needed complete dentures were randomly distributed into three equal groups. Group I: Patients used maxillary complete dentures 3D printed without additives. Group II: Patients used maxillary complete dentures 3D after reinforcement by Nano-ZrO2 (0.4%) by Wt. Group III: Patients used maxillary complete dentures 3D printed after reinforcement by Nano-TiO2 (0.4%) by Wt. For microbial evaluation, a cotton swab was taken from the mucosa and the intaglio surface of maxillary dentures, and microbial colonization was evaluated by calculating the number of colony-forming units of S. aureus on mannitol salt agar plates and C. albicans on Sabouraud's dextrose agar plates after 48 hours of incubation at insertion, 6 months, 12 months and 18 months. Patient satisfaction was evaluated 15 days after insertion and at 6, 12, and 18 months. The values of microbial colonization and patient satisfaction were analyzed via repeated-measures ANOVA followed by Tukey's multiple comparison test.
Read the detailed description
This study aims to compare the effect of 3D printed denture base without nanoparticles and 3D printed denture base reinforced with ZrO2 and TiO2 nanoparticles on completely edentulous patients, as regards:
- Microbial colonization.
- Patient satisfaction.
The following steps will be carried out for all patients:
- Conventional primary and final impressions will be made for each patient
- Master casts (upper and lower) and occlusion blocks will be scanned by an extra-oral scanner.
- Files in standard tessellation language (STL) format of master casts and jaw relation records will be imported to the software platform. The software will enable virtually simultaneous mounting and aligning. Each denture will have two STL files that will be printed separately: one for the denture base and one for the teeth, using a 3D printer.29
- For Group Ι, the designed dentures STL files will be sent to the 3D printer software. Pink denture base resin will be used to print denture bases without nanoparticles.
- For Group II, Pink denture base resin reinforced by Nanoparticles (ZrO2) will be used to print denture bases.
- For Group Ш, Pink denture base resin reinforced by Nanoparticles (TiO2) will be used to print denture bases.
- White teeth resin will be utilized for teeth printing for all groups. Finally, teeth will be attached to recessed pockets in the dentures bases via resin. Followed by finishing. Eventually, dentures will be placed in the post-curing unit.
All patients will be given similar post insertion instructions and a regular oral and denture hygiene protocol.
- Conditions
- Denture Stomatitis
- Being tested
- antimicrobial agent
- Keywords
- 3Dprinted resin, nanoparticles, antimicrobial effect
- Medical subject headings
- Stomatitis, Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antimicrobial agentCombination product
Also called antimcrobial ffect
Adding nanoparticles to 3Dprinted denture base resin improve the properties of the material
| Study group | Role | What they receive |
|---|---|---|
| Nanoparticles | Experimental | Group II: Patients used maxillary complete dentures 3D after reinforcement by Nano-ZrO2 (0.4%) by Wt. Group III: Patients used maxillary complete dentures 3D printed after reinforcement by Nano-TiO2 (0.4%) by Wt Receives: Combination Product: antimicrobial agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial effect
Cotton swabs were taken from the mucosa and the intaglio surface of maxillary dentures, and microbial colonization was evaluated by calculating the number of colony-forming units of S. aureus on mannitol salt agar plates and C. albicans on Sabouraud's dextrose agar plates after 48 hours of incubation at insertion, 6 months, 12 months and 18 months.
Measured: 18 months
Patient satisfaction
Patient satisfaction was evaluated 15 days after insertion and at 6, 12, and 18 months. Patients were requested to assess their overall satisfaction with their dentures through the visual analog scale. The patients were asked five questions: "How satisfied were you with your prosthesis considering aesthetics, speech, masticatory efficiency, hygiene, and comfort?" A ten-point scale was used to evaluate each question; the minimum score is zero, while the maximum score is ten. Higher scores mean a better outcome.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start10 Feb 2023
- Primary completion20 Jul 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Denture StomatitisStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This study aimed to compare the effects of adding nanoZrO2 (0.4% wt) and nanoTiO2 (0.4% wt) to 3D-printed acrylic resin dentures in complete edentulous patients on microbial colonization and patient satisfaction.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed Teama, Tanta University
- Investigators
- Houda MA Rashad, professor, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921577
- Sponsor's protocol ID
- RP 2-23 1
- Acronym
- dimensions
- Status last verified
- Apr 2025
- First submitted
- 14 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the guidelines of human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.
Publications
Ahmed Teama EM, Amin Rashad HM, Mohamed Shakal EAE, Hegazy EE. Clinical and microbial study of reinforced 3D-printed maxillary denture base resin: a randomized trial. BMC Oral Health. 2025 Jul 17;25(1):1192. doi: 10.1186/s12903-025-06601-2.
PubMed 40676540
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial and Laboratory Study of 3D Printed Reinforced Acrylic Denture
- ClinicalTrials.gov ID
- NCT06921577
- Acronym / sponsor ID
- dimensions / RP 2-23 1
- Conditions
- Denture Stomatitis
- Keywords
- 3Dprinted resin, nanoparticles, antimicrobial effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 10 Apr 2025 (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.
Statement of problem: 3D printed denture base resin is needed to reinforce Purpose: To evaluate the effects of adding nano-ZrO2 and nano-TiO2 on microbial colonization and patient satisfaction with 3D-printed maxillary complete dentures.
Materials and Methods: Twenty-four patients who needed complete dentures were randomly distributed into three equal groups. Group I: Patients used maxillary complete dentures 3D printed without additives. Group II: Patients used maxillary complete dentures 3D after reinforcement by Nano-ZrO2 (0.4%) by Wt. Group III: Patients used maxillary complete dentures 3D printed after reinforcement by Nano-TiO2 (0.4%) by Wt. For microbial evaluation, a cotton swab was taken from the mucosa and the intaglio surface of maxillary dentures, and microbial colonization was evaluated by calculating the number of colony-forming units of S. aureus on mannitol salt agar plates and C. albicans on Sabouraud's dextrose agar plates after 48 hours of incubation at insertion, 6 months, 12 months and 18 months. Patient satisfaction was evaluated 15 days after insertion and at 6, 12, and 18 months. The values of microbial colonization and patient satisfaction were analyzed via repeated-measures ANOVA followed by Tukey's multiple comparison test.
Detailed description
This study aims to compare the effect of 3D printed denture base without nanoparticles and 3D printed denture base reinforced with ZrO2 and TiO2 nanoparticles on completely edentulous patients, as regards:
- Microbial colonization.
- Patient satisfaction.
The following steps will be carried out for all patients:
- Conventional primary and final impressions will be made for each patient
- Master casts (upper and lower) and occlusion blocks will be scanned by an extra-oral scanner.
- Files in standard tessellation language (STL) format of master casts and jaw relation records will be imported to the software platform. The software will enable virtually simultaneous mounting and aligning. Each denture will have two STL files that will be printed separately: one for the denture base and one for the teeth, using a 3D printer.29
- For Group Ι, the designed dentures STL files will be sent to the 3D printer software. Pink denture base resin will be used to print denture bases without nanoparticles.
- For Group II, Pink denture base resin reinforced by Nanoparticles (ZrO2) will be used to print denture bases.
- For Group Ш, Pink denture base resin reinforced by Nanoparticles (TiO2) will be used to print denture bases.
- White teeth resin will be utilized for teeth printing for all groups. Finally, teeth will be attached to recessed pockets in the dentures bases via resin. Followed by finishing. Eventually, dentures will be placed in the post-curing unit.
All patients will be given similar post insertion instructions and a regular oral and denture hygiene protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study aimed to compare the effects of adding nanoZrO2 (0.4% wt) and nanoTiO2 (0.4% wt) to 3D-printed acrylic resin dentures in complete edentulous patients on microbial colonization and patient satisfaction.
| Arm | Type | Receives |
|---|---|---|
| Nanoparticles | Experimental | Combination Product: antimicrobial agentGroup II: Patients used maxillary complete dentures 3D after reinforcement by Nano-ZrO2 (0.4%) by Wt. Group III: Patients used maxillary complete dentures 3D printed after reinforcement by Nano-TiO2 (0.4%) by Wt |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Completely edentulous patients with good local and systemic health.
- Patients' ages range from 50 to 70 years old.
- Must have adequate interarch space and class Ⅰ angle classification.
- Must have a reasonable neuromuscular control. Patient exclusion criteria
- Patients with any diseases that may affect denture construction
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| antimicrobial agentAlso: antimcrobial ffectAdding nanoparticles to 3Dprinted denture base resin improve the properties of the material | Combination product | Nanoparticles |
Primary outcome
Antimicrobial effect
Time frame: 18 months
Cotton swabs were taken from the mucosa and the intaglio surface of maxillary dentures, and microbial colonization was evaluated by calculating the number of colony-forming units of S. aureus on mannitol salt agar plates and C. albicans on Sabouraud's dextrose agar plates after 48 hours of incubation at insertion, 6 months, 12 months and 18 months.
Patient satisfaction
Time frame: 18 months
Patient satisfaction was evaluated 15 days after insertion and at 6, 12, and 18 months. Patients were requested to assess their overall satisfaction with their dentures through the visual analog scale. The patients were asked five questions: "How satisfied were you with your prosthesis considering aesthetics, speech, masticatory efficiency, hygiene, and comfort?" A ten-point scale was used to evaluate each question; the minimum score is zero, while the maximum score is ten. Higher scores mean a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 40676540Ahmed Teama EM, Amin Rashad HM, Mohamed Shakal EAE, Hegazy EE. Clinical and microbial study of reinforced 3D-printed maxillary denture base resin: a randomized trial. BMC Oral Health. 2025 Jul 17;25(1):1192. doi: 10.1186/s12903-025-06601-2.
- Individual participant dataSharing planned: No. According to the guidelines of human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.
Related trials for Denture Stomatitis
Not yet recruiting
Development of a Sanitizing Tablet for Removable Partial Dentures
Denture Stomatitis
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.
Houda MA Rashad, professor study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antimicrobial agent in people with Denture Stomatitis, run by Tanta 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 7 inclusion and 0 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: finished, as of the sponsor's last update on 10 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Antimicrobial effect (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06921577, which also lists 1 linked publication.
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 10 Apr 2025.