DentureNCT07672847
Effect of Certain Denture Disinfectants on Surface Topography, Microhardness and Dimensional Stability of CAD/CAM Milled Polymethyl Methacrylate and Polyether Ether Ketone Denture Base Materials
A study testing M0 group, M1 group : PMMA+ Sodium hypochlorite and M2 group: PMMA+ Chlorhexidine in people with Denture and CAD/CAM, run by Menoufia University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare the influence of different denture cleansing methods using 1% sodium hypochlorite solution, 0.2% chlorhexidine solution and effervescent alkaline peroxide tablet solution -according to manufacturer's instructions- on surface roughness , microhardness and dimensional stability… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- M0 group, M1 group : PMMA+ Sodium hypochlorite and M2 group: PMMA+ Chlorhexidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Used prefabricated CAD-CAM blocks (PMMA and PEEK, dental grade)
- All specimens milled using standardized CAD-CAM protocols
- Materials from same brand, batch and shade per group
- All specimens polished to a clinical high gloss standard
- Used standardized specimen geometry
Who cannot join
- Specimens fabricated using a method other than CAD-CAM milling
- Use blocks from different manufacturer, batches or shades within the same test group
- Use specimens with fabrication defects (visible porosity, cracks, internal voids) or obvious milling errors (tool chattering marks, incomplete milling)
- Specimens with dimensional inaccuracy
- Specimens subjected to incorrect immersion time, temp or concentration of disinfectant
- Use contaminated, not freshly prepared or expired disinfectant solutions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Effect of Certain Denture Disinfectants on Surface Topography, Microhardness and Dimensional Stability of CAD/CAM Milled Polymethyl Methacrylate (PMMA) and Polyether Ether Ketone (PEEK) Denture Base Materials: An In Vitro Study
This study aims to evaluate and compare the influence of different denture cleansing methods using 1% sodium hypochlorite solution, 0.2% chlorhexidine solution and effervescent alkaline peroxide tablet solution -according to manufacturer's instructions- on surface roughness , microhardness and dimensional stability (%) of CAD-CAM Milled both Polymethyl methacrylate and Polyether Ether Ketone denture base materials.
Read the detailed description
Dentures are custom-made medical devices prescribed by dentists and clinical dental technicians to replace oral hard and soft tissue structures. Dentures consist of the denture base and denture teeth. Denture bases can be fabricated using acrylic (polymethylmethacrylate [PMMA]), metal alloys (cobalt-chromium) and polymers, such as nylon-based thermoplastic resins, polyether ether ketone [PEEK] and aryl ketone polymer. Heat-cured PMMA is the most commonly used denture base; this is inherently porous, non shedding and readily aggregates denture plaque. Denture teeth can be fabricated from acrylic, composite resin, or porcelain as these are significantly smoother surfaces; however, denture plaque can grow around the 'tooth-gingivae' interface, which represents the interface between the denture teeth and pink resin of the denture, representing the gingival tissue.
Denture plaque contains pathogenic microbes including, Candida albicans (linked with denture stomatitis) and Streptococcus mutans (linked with caries development). Methicillin resistant Staphylococcus aureus has been previously isolated from denture patients in general practice and the general hospital setting; however, it is unknown whether cross contamination or infection can occur when handling dentures. Most patients exhibit poor denture hygiene due to inadequate knowledge of optimal/correct cleaning techniques1 and a lack of standardization in denture hygiene assessments; dentists infrequently assess and record patients' denture hygiene status. Poor denture hygiene leads to increased risk of dental caries, periodontal disease, denture stomatitis and halitosis. Improper denture care negatively impacts denture clinical longevity and increases denture plaque aggregation. For example, scratches due to improper brushing technique, such as brushing with too hard a brush, can increase microbial growth, while inappropriate denture cleaner use can permanently damage a denture beyond clinical use. A working knowledge of denture base/tooth materials and denture cleaning methods should ensure optimal denture cleanliness without compromising material integrity and clinical longevity. Therefore, clinician-assisted patient education can improve patients' denture hygiene. The dental team is best suited to help provide patients with the necessary oral and denture hygiene education. The incorporation of CAD/CAM technology into complete denture design and fabrication streamlines the clinical and laboratory processes and provides improved physical properties that enhance denture quality. Studies have shown that CAD-CAM milled resins typically outperform 3D-printed materials in thermal stress resistance. Also, surface properties such as roughness, microhardness, and color stability are crucial determinants of durability and patient satisfaction. For instance, rougher surfaces can promote microbial adhesion, leading to biofilm formation and staining, while smoother, harder surfaces resist wear and microbial colonization. CAD-CAM milled PMMA showed significantly less C adherence. 3 and superior dimensional accuracy and stability compared with 3D printing and conventional methods. It remains the superior choice for long-term denture durability due to its high mechanical strength and wear resistance.
This study aims to evaluate and compare the influence of different denture cleansing methods using 1% sodium hypochlorite solution, 0.2% chlorhexidine solution and effervescent alkaline peroxide tablet solution -according to manufacturer's instructions- on surface roughness , microhardness and dimensional stability (%) of CAD-CAM Milled both Polymethyl methacrylate and Polyether Ether Ketone denture base materials.
- Being tested
- M0 group, M1 group : PMMA+ Sodium hypochlorite, M2 group: PMMA+ Chlorhexidine, M3 group : PMMA + Effervescent Alkaline Peroxide Tablet, E0 group : PEEK control group
- Keywords
- Dimensional Stability, CAD/CAM, Polyether Ether Ketone, PMMA, Topography, Microhardness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M0 groupOther
Immersed in distilled water at 37 c for 6 months
M1 group : PMMA+ Sodium hypochloriteOther
Immersed in 1% sodium hypochlorite solution for 6 months
M2 group: PMMA+ ChlorhexidineOther
Immersed in 0.2% chlorhexidine solution for 6 months
M3 group : PMMA + Effervescent Alkaline Peroxide TabletOther
Immersed in Effervescent tablet denture cleanser solution for 6 months
E0 group : PEEK control groupOther
Immersed in distilled water at 37 c for 6 months
E1 group : PEEK + Sodium hypochloriteOther
Immersed in 1% sodium hypochlorite solution for 6 months
E2 group : PEEK +Chlorhexidine groupOther
Immersed in 0.2% chlorhexidine solution for 6 months
E3 group: PEEK + Effervescent Alkaline Peroxide TabletOther
Immersed in Effervescent tablet denture cleanser solution for 6 months
| Study group | Role | What they receive |
|---|---|---|
| M0 group | Placebo comparator | Material used is PMMA Distilled water - control group Disinfection method :Immersed in distilled water at 37 c for 6 months Receives: Other: M0 group |
| M1 group | Experimental | Material used (PMMA) Type of cleanser: Sodium hypochlorite (NaOCl) Disinfection method :immersed in 1% sodium hypochlorite solution for 6 months Receives: Other: M1 group : PMMA+ Sodium hypochlorite |
| M2 Group | Experimental | Material: PMMA Type of cleanser :Chlorhexidine (CHX) Disinfection method :Immersed in 0.2% chlorhexidine solution for 6 months Receives: Other: M2 group: PMMA+ Chlorhexidine |
| M3 group | Experimental | Material used : PMMA Type of cleanser: Effervescent Alkaline Peroxide Tablet Disinfection method :Immersed in Effervescent tablet denture cleanser solution for 6 months Receives: Other: M3 group : PMMA + Effervescent Alkaline Peroxide Tablet |
| E0 group: (PEEK Control group) | Placebo comparator | Material: PEEK Distilled water : control group Disinfection method: Immersed in distilled water at 37 c for 6 months Receives: Other: E0 group : PEEK control group |
| E1 group | Experimental | Material : PEEK Type of cleanser :Sodium hypochlorite (NaOCl) Disinfection method :Immersed in 1% sodium hypochlorite solution for 6 months Receives: Other: E1 group : PEEK + Sodium hypochlorite |
| E2 group | Experimental | Material : PEEK Type of cleanser :Chlorhexidine (CHX) Disinfection method :Immersed in 0.2% chlorhexidine solution for 6 months Receives: Other: E2 group : PEEK +Chlorhexidine group |
| E3 group | Experimental | Material : PEEK Type of cleanser : Effervescent Alkaline Peroxide Tablet Disinfection method : Immersed in Effervescent tablet denture cleanser solution for 6 months Receives: Other: E3 group: PEEK + Effervescent Alkaline Peroxide Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Roughness Measurement
Surface roughness (Ra) was measured using a profilometer. Each specimen was scanned at three random locations, and the mean value was recorded. The device was calibrated using the manufacturer's reference standard prior to each measurement session.
Measured: 6 months
Secondary outcomes (1)
Microhardness Evaluation
Surface hardness was determined by loading each specimen for 15 s with a force of 50 g, after mounting it on the microhardness tester. A rhomboid-shaped indentation was obtained on each specimen and its image was transferred to the computer monitor with the help of a microscope present along with the microhardness tester. The longest diagonal of the diamond indentation was marked and Vickers hardness number was calculated with the help of the software
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start31 Jan 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DentureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa zain, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672847
- Sponsor's protocol ID
- DP-01-26-106
- Status last verified
- Jan 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effect of Certain Denture Disinfectants on Surface Topography, Microhardness and Dimensional Stability of CAD/CAM Milled Polymethyl Methacrylate (PMMA) and Polyether Ether Ketone (PEEK) Denture Base Materials: An In Vitro Study
- ClinicalTrials.gov ID
- NCT07672847
- Acronym / sponsor ID
- DP-01-26-106
- Keywords
- Dimensional Stability, CAD/CAM, Polyether Ether Ketone, PMMA, Topography, Microhardness
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 29 Jun 2026 (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.
This study aims to evaluate and compare the influence of different denture cleansing methods using 1% sodium hypochlorite solution, 0.2% chlorhexidine solution and effervescent alkaline peroxide tablet solution -according to manufacturer's instructions- on surface roughness , microhardness and dimensional stability (%) of CAD-CAM Milled both Polymethyl methacrylate and Polyether Ether Ketone denture base materials.
Detailed description
Dentures are custom-made medical devices prescribed by dentists and clinical dental technicians to replace oral hard and soft tissue structures. Dentures consist of the denture base and denture teeth. Denture bases can be fabricated using acrylic (polymethylmethacrylate [PMMA]), metal alloys (cobalt-chromium) and polymers, such as nylon-based thermoplastic resins, polyether ether ketone [PEEK] and aryl ketone polymer. Heat-cured PMMA is the most commonly used denture base; this is inherently porous, non shedding and readily aggregates denture plaque. Denture teeth can be fabricated from acrylic, composite resin, or porcelain as these are significantly smoother surfaces; however, denture plaque can grow around the 'tooth-gingivae' interface, which represents the interface between the denture teeth and pink resin of the denture, representing the gingival tissue.
Denture plaque contains pathogenic microbes including, Candida albicans (linked with denture stomatitis) and Streptococcus mutans (linked with caries development). Methicillin resistant Staphylococcus aureus has been previously isolated from denture patients in general practice and the general hospital setting; however, it is unknown whether cross contamination or infection can occur when handling dentures. Most patients exhibit poor denture hygiene due to inadequate knowledge of optimal/correct cleaning techniques1 and a lack of standardization in denture hygiene assessments; dentists infrequently assess and record patients' denture hygiene status. Poor denture hygiene leads to increased risk of dental caries, periodontal disease, denture stomatitis and halitosis. Improper denture care negatively impacts denture clinical longevity and increases denture plaque aggregation. For example, scratches due to improper brushing technique, such as brushing with too hard a brush, can increase microbial growth, while inappropriate denture cleaner use can permanently damage a denture beyond clinical use. A working knowledge of denture base/tooth materials and denture cleaning methods should ensure optimal denture cleanliness without compromising material integrity and clinical longevity. Therefore, clinician-assisted patient education can improve patients' denture hygiene. The dental team is best suited to help provide patients with the necessary oral and denture hygiene education. The incorporation of CAD/CAM technology into complete denture design and fabrication streamlines the clinical and laboratory processes and provides improved physical properties that enhance denture quality. Studies have shown that CAD-CAM milled resins typically outperform 3D-printed materials in thermal stress resistance. Also, surface properties such as roughness, microhardness, and color stability are crucial determinants of durability and patient satisfaction. For instance, rougher surfaces can promote microbial adhesion, leading to biofilm formation and staining, while smoother, harder surfaces resist wear and microbial colonization. CAD-CAM milled PMMA showed significantly less C adherence. 3 and superior dimensional accuracy and stability compared with 3D printing and conventional methods. It remains the superior choice for long-term denture durability due to its high mechanical strength and wear resistance.
This study aims to evaluate and compare the influence of different denture cleansing methods using 1% sodium hypochlorite solution, 0.2% chlorhexidine solution and effervescent alkaline peroxide tablet solution -according to manufacturer's instructions- on surface roughness , microhardness and dimensional stability (%) of CAD-CAM Milled both Polymethyl methacrylate and Polyether Ether Ketone denture base materials.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| M0 group | Placebo comparator | Other: M0 groupMaterial used is PMMA Distilled water - control group Disinfection method :Immersed in distilled water at 37 c for 6 months |
| M1 group | Experimental | Other: M1 group : PMMA+ Sodium hypochloriteMaterial used (PMMA) Type of cleanser: Sodium hypochlorite (NaOCl) Disinfection method :immersed in 1% sodium hypochlorite solution for 6 months |
| M2 Group | Experimental | Other: M2 group: PMMA+ ChlorhexidineMaterial: PMMA Type of cleanser :Chlorhexidine (CHX) Disinfection method :Immersed in 0.2% chlorhexidine solution for 6 months |
| M3 group | Experimental | Other: M3 group : PMMA + Effervescent Alkaline Peroxide TabletMaterial used : PMMA Type of cleanser: Effervescent Alkaline Peroxide Tablet Disinfection method :Immersed in Effervescent tablet denture cleanser solution for 6 months |
| E0 group: (PEEK Control group) | Placebo comparator | Other: E0 group : PEEK control groupMaterial: PEEK Distilled water : control group Disinfection method: Immersed in distilled water at 37 c for 6 months |
| E1 group | Experimental | Other: E1 group : PEEK + Sodium hypochloriteMaterial : PEEK Type of cleanser :Sodium hypochlorite (NaOCl) Disinfection method :Immersed in 1% sodium hypochlorite solution for 6 months |
| E2 group | Experimental | Other: E2 group : PEEK +Chlorhexidine groupMaterial : PEEK Type of cleanser :Chlorhexidine (CHX) Disinfection method :Immersed in 0.2% chlorhexidine solution for 6 months |
| E3 group | Experimental | Other: E3 group: PEEK + Effervescent Alkaline Peroxide TabletMaterial : PEEK Type of cleanser : Effervescent Alkaline Peroxide Tablet Disinfection method : Immersed in Effervescent tablet denture cleanser solution for 6 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Used prefabricated CAD-CAM blocks (PMMA and PEEK, dental grade)
- All specimens milled using standardized CAD-CAM protocols
- Materials from same brand, batch and shade per group
- All specimens polished to a clinical high gloss standard
- Used standardized specimen geometry
Key exclusion criteria (6 listed)
- Specimens fabricated using a method other than CAD-CAM milling
- Use blocks from different manufacturer, batches or shades within the same test group
- Use specimens with fabrication defects (visible porosity, cracks, internal voids) or obvious milling errors (tool chattering marks, incomplete milling)
- Specimens with dimensional inaccuracy
- Specimens subjected to incorrect immersion time, temp or concentration of disinfectant
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 |
|---|---|---|
| M0 groupImmersed in distilled water at 37 c for 6 months | Other | M0 group |
| M1 group : PMMA+ Sodium hypochloriteImmersed in 1% sodium hypochlorite solution for 6 months | Other | M1 group |
| M2 group: PMMA+ ChlorhexidineImmersed in 0.2% chlorhexidine solution for 6 months | Other | M2 Group |
| M3 group : PMMA + Effervescent Alkaline Peroxide TabletImmersed in Effervescent tablet denture cleanser solution for 6 months | Other | M3 group |
| E0 group : PEEK control groupImmersed in distilled water at 37 c for 6 months | Other | E0 group: (PEEK Control group) |
| E1 group : PEEK + Sodium hypochloriteImmersed in 1% sodium hypochlorite solution for 6 months | Other | E1 group |
| E2 group : PEEK +Chlorhexidine groupImmersed in 0.2% chlorhexidine solution for 6 months | Other | E2 group |
| E3 group: PEEK + Effervescent Alkaline Peroxide TabletImmersed in Effervescent tablet denture cleanser solution for 6 months | Other | E3 group |
Primary outcome
Surface Roughness Measurement
Time frame: 6 months
Surface roughness (Ra) was measured using a profilometer. Each specimen was scanned at three random locations, and the mean value was recorded. The device was calibrated using the manufacturer's reference standard prior to each measurement session.
1 secondary outcome
Microhardness Evaluation
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M0 group, M1 group : PMMA+ Sodium hypochlorite and M2 group: PMMA+ Chlorhexidine in people with Denture and CAD/CAM, 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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 29 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Surface Roughness Measurement (time frame: 6 months). 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 29 Jun 2026.