Complete DentureNCT07091552
Clinical Assessment of CAD/CAM Monolithic Complete Denture
A study testing CAD/CAM monolithic denture and Conventional denture in people with Complete Denture, run by Eman Assam at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate trueness, tooth position, retention, and patient satisfaction of CAD/CAM monolithic complete denture Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complete Denture
- What is being tested?
- CAD/CAM monolithic denture and Conventional denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2024to 5 Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completely edentulous patients, and willing to participate and sign the informed consent.
- No cognitive or psychological deficits.
- Moderate arch size with moderate undercut.
- No retrognathic or prognathic jaw relationship. (Normal horizontal ridge relationship)
Who cannot join
- Participants having undercuts, flabby ridge, severely resorbed ridges.
- Participants with noticeably poor neuromuscular control, hyposalivation, general health, or other issues rendering repeated appointments difficult.
- Oral mucosa exhibits papillary hyperplasia or pathologic changes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of CAD/CAM Monolithic Complete Denture (Cross Over Controlled Clinical Trial)
The aim of the study is to evaluate trueness, tooth position, retention, and patient satisfaction of CAD/CAM monolithic complete denture
- Conditions
- Complete Denture
- Being tested
- CAD/CAM monolithic denture, Conventional denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM monolithic dentureDevice
Based on the workflow suggested by the Ivoclar digital denture, conventional complete dentures will be scanned by using desktop scanner (Medit T710). The cameo and intaglio surfaces of the complete dentures will be scanned, and the scanned data will be exported as Standard Tessellation Language (STL) file to start the milling process.
For the milling process, monolithic denture will be milled from a bicolored disk (Ivotion). One side is the denture base material made of high impact optimized polymethyl methacrylate (PMMA) while the other is the teeth material made of highly cross-linked PMMA with no filler. The bicolor disk is milled in a 5-axis milling machine in wet condition, through an uninterrupted milling process. Following the fast milling process the dentures will be finished and polished.
Conventional dentureDevice
The conventional set will be fabricated with the 5-appointment process: preliminary impressions (first appointment); definitive impressions (second appointment); interocclusal records and tooth selection (third appointment), the size of the teeth will be selected according to the library provided by 3Shape Dental System software to match the disc size; wax trial placement (fourth appointment); and denture adjustment and placement (fifth appointment). Conventional CD will be fabricated with the conventional lost wax technique and heat-polymerizing acrylic resin. The heat-polymerized CDs will be finished, and polished before placement. Adjustments will be made for the polished surface, tissue surface, borders, and occlusion. Occlusal errors will be adjusted through clinical remount of the finished dentures.
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM monolithic denture | Experimental | Not described Receives: Device: CAD/CAM monolithic denture |
| Conventional denture | Active comparator | Not described Receives: Device: Conventional denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trueness of CAD/CAM monolithic dentures
The CAD/CAM monolithic dentures will be scanned with laboratory scanner (Medit T710) . Data from the scans will be stored in a STL format. The scans of the conventional dentures will be considered the reference STL files. The scans of each denture base will be imported into an analytic software program. All the study denture file will be separated into cameo, and intaglio portions, according to the software program processing protocol. To determine the trueness (root mean square (RMS)), measured in mm of conventional and monolithic complete dentures, comparisons will be conducted for the cameo, and intaglio portions. All the study sample STL files will be superimposed to the corresponding reference STL files using voxel-based best-fit alignment in the surface matching software. Color maps will also be produced to demonstrate the qualitative three-dimensional differences between the test and reference files
Measured: Baseline (Day 1)
Accuracy of tooth position
Accuracy will be verified by superimposing the tooth region data from the heat-cured and monolithic dentures on the tooth region data from the wax dentures using best fit algorithm of 3D data analytical software and measuring the displacement of the tooth arrangement. In addition, colour maps will be created using the 3D comparison function to visually display the direction and amount of tooth displacement. Using the software, a total of 48 measurement points will be established for maxillary dentures. Twenty-four measurement points will be defined on the anterior teeth: at the cusp tip or center of the incisal edge; at the mesio- and disto-incisal angles; and at the center of the lingual face of each tooth. Similarly, 24 measurement points will be defined on the posterior teeth at the cusp tips of each tooth. The average value of the dentures will be calculated for each of the 48 measurement points, and this will be used as the representative value of the measurement point.
Measured: Baseline (Day 1)
Objective assessment of complete denture retention
Retention will be evaluated objectively by using digital force gauge that will be connected to a wire loop which is attached on the denture bases. This force will be measured in newtons (N) and recorded as the denture's retention. A total of 3 measurements will be made for each denture by the same investigator. The highest value will be recorded as the peak retention force and used for the analysis
Measured: Baseline (Day 1)
Subjective assessment of complete denture retention
Complete dentures for each subject will be subjectively evaluated for denture retention by the use of the scoring system described by Kapur. Each denture is scored on a scale from 0 to 6 based on clinical examination:
The total score (0-6) is used to classify denture performance as:
Clinically poor: <6 Clinically fair: 6-8 Clinically good: >8
Measured: up to 6 months
Patient satisfaction
A patient satisfaction questionnaire will be designed according to the Guckes questionnaires. Subjects will be asked eight questions that pertained to their satisfaction with their conventional or monolithic dentures. The responses: completely satisfied, partially satisfied, and dissatisfied were coded as 2, 1, and 0, respectively. The satisfaction variable was formed by adding the scores from the eight questions; the range was from 0 (very dissatisfied) to 16 (totally satisfied).
Measured: up to 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 Jul 2025
- Study start12 Jan 2024
- Primary completion5 Apr 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete DentureStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eman Assam
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Eman Assam, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091552
- Sponsor's protocol ID
- 9208697
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of CAD/CAM Monolithic Complete Denture (Cross Over Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07091552
- Acronym / sponsor ID
- 9208697
- Conditions
- Complete Denture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Eman AssamUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 29 Jul 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.
The aim of the study is to evaluate trueness, tooth position, retention, and patient satisfaction of CAD/CAM monolithic complete denture
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM monolithic denture | Experimental | Device: CAD/CAM monolithic denture |
| Conventional denture | Active comparator | Device: Conventional denture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Completely edentulous patients, and willing to participate and sign the informed consent.
- No cognitive or psychological deficits.
- Moderate arch size with moderate undercut.
- No retrognathic or prognathic jaw relationship. (Normal horizontal ridge relationship)
Key exclusion criteria (3 listed)
- Participants having undercuts, flabby ridge, severely resorbed ridges.
- Participants with noticeably poor neuromuscular control, hyposalivation, general health, or other issues rendering repeated appointments difficult.
- Oral mucosa exhibits papillary hyperplasia or pathologic changes
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 |
|---|---|---|
| CAD/CAM monolithic dentureBased on the workflow suggested by the Ivoclar digital denture, conventional complete dentures will be scanned by using desktop scanner (Medit T710). The cameo and intaglio surfaces of the complete dentures will be scanned, and the scanned data will be exported as Standard Tessellation Language (STL) file to start the milling process. For the milling process, monolithic denture will be milled from a bicolored disk (Ivotion). One side is the denture base material made of high impact optimized polymethyl methacrylate (PMMA) while the other is the teeth material made of highly cross-linked PMMA with no filler. The bicolor disk is milled in a 5-axis milling machine in wet condition, through an uninterrupted milling process. Following the fast milling process the dentures will be finished and polished. | Device | CAD/CAM monolithic denture |
| Conventional dentureThe conventional set will be fabricated with the 5-appointment process: preliminary impressions (first appointment); definitive impressions (second appointment); interocclusal records and tooth selection (third appointment), the size of the teeth will be selected according to the library provided by 3Shape Dental System software to match the disc size; wax trial placement (fourth appointment); and denture adjustment and placement (fifth appointment). Conventional CD will be fabricated with the conventional lost wax technique and heat-polymerizing acrylic resin. The heat-polymerized CDs will be finished, and polished before placement. Adjustments will be made for the polished surface, tissue surface, borders, and occlusion. Occlusal errors will be adjusted through clinical remount of the finished dentures. | Device | Conventional denture |
Primary outcome
Trueness of CAD/CAM monolithic dentures
Time frame: Baseline (Day 1)
The CAD/CAM monolithic dentures will be scanned with laboratory scanner (Medit T710) . Data from the scans will be stored in a STL format. The scans of the conventional dentures will be considered the reference STL files. The scans of each denture base will be imported into an analytic software program. All the study denture file will be separated into cameo, and intaglio portions, according to the software program processing protocol. To determine the trueness (root mean square (RMS)), measured in mm of conventional and monolithic complete dentures, comparisons will be conducted for the cameo, and intaglio portions. All the study sample STL files will be superimposed to the corresponding reference STL files using voxel-based best-fit alignment in the surface matching software. Color maps will also be produced to demonstrate the qualitative three-dimensional differences between the test and reference files
Accuracy of tooth position
Time frame: Baseline (Day 1)
Accuracy will be verified by superimposing the tooth region data from the heat-cured and monolithic dentures on the tooth region data from the wax dentures using best fit algorithm of 3D data analytical software and measuring the displacement of the tooth arrangement. In addition, colour maps will be created using the 3D comparison function to visually display the direction and amount of tooth displacement. Using the software, a total of 48 measurement points will be established for maxillary dentures. Twenty-four measurement points will be defined on the anterior teeth: at the cusp tip or center of the incisal edge; at the mesio- and disto-incisal angles; and at the center of the lingual face of each tooth. Similarly, 24 measurement points will be defined on the posterior teeth at the cusp tips of each tooth. The average value of the dentures will be calculated for each of the 48 measurement points, and this will be used as the representative value of the measurement point.
Objective assessment of complete denture retention
Time frame: Baseline (Day 1)
Retention will be evaluated objectively by using digital force gauge that will be connected to a wire loop which is attached on the denture bases. This force will be measured in newtons (N) and recorded as the denture's retention. A total of 3 measurements will be made for each denture by the same investigator. The highest value will be recorded as the peak retention force and used for the analysis
Subjective assessment of complete denture retention
Time frame: up to 6 months
Complete dentures for each subject will be subjectively evaluated for denture retention by the use of the scoring system described by Kapur. Each denture is scored on a scale from 0 to 6 based on clinical examination: The total score (0-6) is used to classify denture performance as: Clinically poor: <6 Clinically fair: 6-8 Clinically good: >8
Patient satisfaction
Time frame: up to 6 months
A patient satisfaction questionnaire will be designed according to the Guckes questionnaires. Subjects will be asked eight questions that pertained to their satisfaction with their conventional or monolithic dentures. The responses: completely satisfied, partially satisfied, and dissatisfied were coded as 2, 1, and 0, respectively. The satisfaction variable was formed by adding the scores from the eight questions; the range was from 0 (very dissatisfied) to 16 (totally satisfied).
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 29 Jul 2025.
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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.
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 CAD/CAM monolithic denture and Conventional denture in people with Complete Denture, run by Eman Assam 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 4 inclusion and 3 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 29 Jul 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?
Trueness of CAD/CAM monolithic dentures (time frame: Baseline (Day 1)). The study lists 5 primary outcomes in all. 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 Jul 2025.