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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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
Conditions the study is for
Denture, CAD/CAM, Stability
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.

Egypt1 site
  • Menoufia University

    Shibīn al Kawm

Other trials in Egypt

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 groups in NCT07672847
Study groupRoleWhat they receive
M0 groupPlacebo comparatorMaterial used is PMMA Distilled water - control group Disinfection method :Immersed in distilled water at 37 c for 6 months
Receives: Other: M0 group
M1 groupExperimentalMaterial 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 GroupExperimentalMaterial: PMMA Type of cleanser :Chlorhexidine (CHX) Disinfection method :Immersed in 0.2% chlorhexidine solution for 6 months
Receives: Other: M2 group: PMMA+ Chlorhexidine
M3 groupExperimentalMaterial 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 comparatorMaterial: 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 groupExperimentalMaterial : 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 groupExperimentalMaterial : 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 groupExperimentalMaterial : 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.

  1. 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)
  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.

  1. First posted29 Jun 2026
  2. Study start31 Jan 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

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)
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

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.

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