Surface Hardness and Wear Resistance of Artificial TeethNCT06179615
Surface Hardness and Wear Characteristics of Prefabricated and CAD/CAM Milled Artificial Teeth
A study testing surface hardness test for denture teeth and wear resistance of denture teeth measurement in people with Surface Hardness and Wear Resistance of Artificial Teeth, run by Mansoura University at 1 site in Egypt.
Trial summary
Purpose: This study aimed to assess the 3-dimentional wear )3D) (volumetric loss) and 2-dimentional wear (2D) (vertical loss) and surface hardness of ready-made (prefabricated) and CAD/CAM milled artificial denture teeth. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surface Hardness and Wear Resistance of Artificial Teeth
- What is being tested?
- surface hardness test for denture teeth and wear resistance of denture teeth measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2022to 13 Sep 2023
- 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 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- completely edentulous
- angle class I maxillomandibular relations
Who cannot join
- Angle's class II, III maxillomandibular relation
- systemic disease that affect the bone and soft tissue health
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surface Hardness and Wear Resistance of Prefabricated and CAD/CAM Milled Artificial Teeth: A Cross-over Clinical Study
Purpose: This study aimed to assess the 3-dimentional wear )3D) (volumetric loss) and 2-dimentional wear (2D) (vertical loss) and surface hardness of ready-made (prefabricated) and CAD/CAM milled artificial denture teeth.
material and methods: In a cross-over study design, ten completely edentulous patients were randomly chosen for this study and given two complete dentures. The first complete denture was constructed with pre-fabricated teeth. The second complete denture was constructed with CAD\CAM milled teeth. The complete denture teeth were 3D scanned at the time of insertion (T0), after three months (T3), and after six months (T6) of denture insertion. Utilizing 3D surface superimposition techniques, the vertical (2D wear), and Volumatic (3D wear) material loss were measured. The hardness of the teeth were evaluated at the time of denture insertion (T0) then after 6 months (T6) of denture insertion by Vickers hardness test. Statistical analysis was done using SPSS software. Paired groups were compared by paired t test. Significant difference was considered if P ≤ 0.05.
- Being tested
- surface hardness test for denture teeth, wear resistance of denture teeth measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surface hardness test for denture teethOther
surface hardness test of denture teeth at insertion then after 6 months of use
wear resistance of denture teeth measurementOther
2D, Vertical wear, 3D Volumetric wear were measured for denture teeth
| Study group | Role | What they receive |
|---|---|---|
| complete denture with prefabricated artificial teeth | Other | complete denture constructed with prefabricated artificial teeth and inserted in the patient mouth to be used for 3, 6 months Receives: Other: surface hardness test for denture teeth; Other: wear resistance of denture teeth measurement |
| complete denture with CAD\CAM milled artificial teeth | Other | complete denture constructed with CAD\CAM Milled artificial teeth and inserted in the patient mouth to be used for 3, 6 months Receives: Other: surface hardness test for denture teeth; Other: wear resistance of denture teeth measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
wear resistance of denture artificial teeth
2D, 3D wear of denture teeth were measured using denture scanning and superimposition of the sanning at insertion to that after 3, 6 months using Exocad soft ware
Measured: 6 months after denture use
surface hardness of the denture artificial teeth
the measurement of surface hardness was done using Vickers's test. this measurements was done at insertion then after 6 months
Measured: 6 months after denture use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start10 Jun 2022
- Primary completion25 Jul 2023
- Study completion13 Sep 2023
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 Surface Hardness and Wear Resistance of Artificial TeethStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aisha Zakaria Hashem Mostafa, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179615
- Sponsor's protocol ID
- A11080622
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abozaed HW, Ali SA, Mostafa AZ. Patient satisfaction and oral health-related quality of life for prefabricated teeth versus CAD-CAM milled acrylic resin denture teeth. A crossover clinical trial. BMC Oral Health. 2025 Oct 10;25(1):1601. doi: 10.1186/s12903-025-06834-1.
PubMed 41073957
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surface Hardness and Wear Resistance of Prefabricated and CAD/CAM Milled Artificial Teeth: A Cross-over Clinical Study
- ClinicalTrials.gov ID
- NCT06179615
- Acronym / sponsor ID
- A11080622
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 22 Dec 2023 (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.
Purpose: This study aimed to assess the 3-dimentional wear )3D) (volumetric loss) and 2-dimentional wear (2D) (vertical loss) and surface hardness of ready-made (prefabricated) and CAD/CAM milled artificial denture teeth.
material and methods: In a cross-over study design, ten completely edentulous patients were randomly chosen for this study and given two complete dentures. The first complete denture was constructed with pre-fabricated teeth. The second complete denture was constructed with CAD\CAM milled teeth. The complete denture teeth were 3D scanned at the time of insertion (T0), after three months (T3), and after six months (T6) of denture insertion. Utilizing 3D surface superimposition techniques, the vertical (2D wear), and Volumatic (3D wear) material loss were measured. The hardness of the teeth were evaluated at the time of denture insertion (T0) then after 6 months (T6) of denture insertion by Vickers hardness test. Statistical analysis was done using SPSS software. Paired groups were compared by paired t test. Significant difference was considered if P ≤ 0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete denture with prefabricated artificial teeth | Other | Other: surface hardness test for denture teeth, Other: wear resistance of denture teeth measurementcomplete denture constructed with prefabricated artificial teeth and inserted in the patient mouth to be used for 3, 6 months |
| complete denture with CAD\CAM milled artificial teeth | Other | Other: surface hardness test for denture teeth, Other: wear resistance of denture teeth measurementcomplete denture constructed with CAD\CAM Milled artificial teeth and inserted in the patient mouth to be used for 3, 6 months |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- completely edentulous
- angle class I maxillomandibular relations
Key exclusion criteria (2 listed)
- Angle's class II, III maxillomandibular relation
- systemic disease that affect the bone and soft tissue health
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 |
|---|---|---|
| surface hardness test for denture teethsurface hardness test of denture teeth at insertion then after 6 months of use | Other | complete denture with CAD\CAM milled artificial teeth, complete denture with prefabricated artificial teeth |
| wear resistance of denture teeth measurement2D, Vertical wear, 3D Volumetric wear were measured for denture teeth | Other | complete denture with CAD\CAM milled artificial teeth, complete denture with prefabricated artificial teeth |
Primary outcome
wear resistance of denture artificial teeth
Time frame: 6 months after denture use
2D, 3D wear of denture teeth were measured using denture scanning and superimposition of the sanning at insertion to that after 3, 6 months using Exocad soft ware
surface hardness of the denture artificial teeth
Time frame: 6 months after denture use
the measurement of surface hardness was done using Vickers's test. this measurements was done at insertion then after 6 months
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 22 Dec 2023.
- Derived from this study: PubMed 41073957Abozaed HW, Ali SA, Mostafa AZ. Patient satisfaction and oral health-related quality of life for prefabricated teeth versus CAD-CAM milled acrylic resin denture teeth. A crossover clinical trial. BMC Oral Health. 2025 Oct 10;25(1):1601. doi: 10.1186/s12903-025-06834-1.
- Individual participant dataSharing planned: No
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.
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 surface hardness test for denture teeth and wear resistance of denture teeth measurement in people with Surface Hardness and Wear Resistance of Artificial Teeth, run by Mansoura 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 2 inclusion and 2 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 22 Dec 2023. 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?
wear resistance of denture artificial teeth (time frame: 6 months after denture use). 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 NCT06179615, 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 22 Dec 2023.