Badly Decayed MolarsNCT06774560
Clinical Evaluation of 3D Printed Versus CAD/CAM Milled Onlays
A study testing CAD/Cam milled onlays and 3D printed onlays in people with Badly Decayed Molars, run by Cairo University.
Trial summary
The digital workflow in dentistry has proven in the past decades to be a time-efficient, multifunctional, effortless, and accessible approach. The inherited shortages milling machines represented by the incapability to produce accurate complex hollow structures may give preference to modern 3D ceramic printing. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Badly Decayed Molars
- What is being tested?
- CAD/Cam milled onlays and 3D printed onlays
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Dec 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 25-45 years.
- Males or females.
- Participants with carious vital ower molars indicated for onlay (one or two missing cusps)
- Patients with at least 20 teeth under occlusion.
- Good oral hygiene.
- Co-operative patients approving to participate in the trial.
- Have sufficient cognitive ability to understand consent procedures.
Who cannot join
- Participants with parafunctional habits or bruxism.
- Participants with systemic diseases or disabilities that may affect participation.
- Heavy smoking.
- Pregnancy.
- Lack of compliance.
- Severe or active periodontal disease.
- Cognitive impairment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of 3D Printed Versus CAD/CAM Milled Onlays Over a Period of One Year: a Randomized Clinical Trial
The digital workflow in dentistry has proven in the past decades to be a time-efficient, multifunctional, effortless, and accessible approach. The inherited shortages milling machines represented by the incapability to produce accurate complex hollow structures may give preference to modern 3D ceramic printing.
Computer-aided-design/computer-aided-manufacturing (CAD/CAM) in dentistry is a digital subtractive approach for manufacturing indirect restorations. Nevertheless, waste materials and milling burs wearing are considered as key disadvantages of CAD/CAM technology, and are the main drive to improve 3D printing technology (additive manufacturing) as the latter has shown considerable efficiency in minimising wasted materials.
Although additive manufacturing has been known since the 1980s, its application in dentistry is relatively new and not fully studied with limited research and in vivo studies on their clinical performance.
- Conditions
- Badly Decayed Molars
- Being tested
- CAD/Cam milled onlays, 3D printed onlays
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/Cam milled onlaysOther
The digital workflow in dentistry has proven in the past decades to be a time-efficient, multifunctional, effortless, and accessible approach. The inherited shortages milling machines represented by the incapability to produce accurate complex hollow structures may give preference to modern 3D ceramic printing.
Computer-aided-design/computer-aided-manufacturing (CAD/CAM) in dentistry is a digital subtractive approach for manufacturing indirect restorations. Nevertheless, waste materials and milling burs wearing are considered as key disadvantages of CAD/CAM technology, and are the main drive to improve 3D printing technology (additive manufacturing) as the latter has shown considerable efficiency in minimising wasted materials.
3D printed onlaysOther
3D printing technologies are developing more intensively in dentistry as this technology has the capacity to produce shapes or models with high accuracy and in a short time. This method of fabrication takes less time and money and saves on materials compared to CAD/CAM.
Although it seems that digital manufacturing technology has made great changes in the restorative dentistry field, this technology is still not fully in use. This is possibly because of the lack of studies and research on this technology, particularly in terms of clinical performance and patient-centred outcomes. 3D printing technologies are novel technologies with a lack of research; therefore, the processing of 3D printing materials is still controversial.
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM milled onlays | Active comparator | CAD/CAM has had a lasting impact on the dental market for decades. Its clinical reliability compared to any other dental material has been well documented. Several clinical studies proved its high clinical performance and survival rate. As CAD/CAM systems have become established in producing indirect restorations, it is considered the gold standard of digital manufacturing technology in dentistry. Receives: Other: CAD/Cam milled onlays |
| 3D printed onlays | Experimental | 3D-printed restorations have shown several advantages. Some studies have shown that the edge and internal gap values of 3D printing restorations are significantly lower than those of milling restorations. Receives: Other: 3D printed onlays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted
Measured: One Year
Secondary outcomes (7)
Retention
This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted
Measured: One Year
Marginal adaptation
This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted
Measured: One Year
Marginal discoloration
This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted
Measured: One Year
Secondary caries
This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted
Measured: One Year
Post-operative hypersensitivity
This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted
Measured: One Year
Surface texture
This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted
Measured: One Year
Anatomic form
This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Badly Decayed MolarsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Sameh Ahmed Farouk, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774560
- Sponsor's protocol ID
- 3DP_CAD/CAMM
- Status last verified
- Dec 2024
- First submitted
- 28 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 3D Printed Versus CAD/CAM Milled Onlays Over a Period of One Year: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06774560
- Acronym / sponsor ID
- 3DP_CAD/CAMM
- Conditions
- Badly Decayed Molars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Jan 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 digital workflow in dentistry has proven in the past decades to be a time-efficient, multifunctional, effortless, and accessible approach. The inherited shortages milling machines represented by the incapability to produce accurate complex hollow structures may give preference to modern 3D ceramic printing.
Computer-aided-design/computer-aided-manufacturing (CAD/CAM) in dentistry is a digital subtractive approach for manufacturing indirect restorations. Nevertheless, waste materials and milling burs wearing are considered as key disadvantages of CAD/CAM technology, and are the main drive to improve 3D printing technology (additive manufacturing) as the latter has shown considerable efficiency in minimising wasted materials.
Although additive manufacturing has been known since the 1980s, its application in dentistry is relatively new and not fully studied with limited research and in vivo studies on their clinical performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM milled onlays | Active comparator | Other: CAD/Cam milled onlaysCAD/CAM has had a lasting impact on the dental market for decades. Its clinical reliability compared to any other dental material has been well documented. Several clinical studies proved its high clinical performance and survival rate. As CAD/CAM systems have become established in producing indirect restorations, it is considered the gold standard of digital manufacturing technology in dentistry. |
| 3D printed onlays | Experimental | Other: 3D printed onlays3D-printed restorations have shown several advantages. Some studies have shown that the edge and internal gap values of 3D printing restorations are significantly lower than those of milling restorations. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 25-45 years.
- Males or females.
- Participants with carious vital ower molars indicated for onlay (one or two missing cusps)
- Patients with at least 20 teeth under occlusion.
- Good oral hygiene.
Key exclusion criteria (7 listed)
- Participants with parafunctional habits or bruxism.
- Participants with systemic diseases or disabilities that may affect participation.
- Heavy smoking.
- Pregnancy.
- Lack of compliance.
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 milled onlaysThe digital workflow in dentistry has proven in the past decades to be a time-efficient, multifunctional, effortless, and accessible approach. The inherited shortages milling machines represented by the incapability to produce accurate complex hollow structures may give preference to modern 3D ceramic printing. Computer-aided-design/computer-aided-manufacturing (CAD/CAM) in dentistry is a digital subtractive approach for manufacturing indirect restorations. Nevertheless, waste materials and milling burs wearing are considered as key disadvantages of CAD/CAM technology, and are the main drive to improve 3D printing technology (additive manufacturing) as the latter has shown considerable efficiency in minimising wasted materials. | Other | CAD/CAM milled onlays |
| 3D printed onlays3D printing technologies are developing more intensively in dentistry as this technology has the capacity to produce shapes or models with high accuracy and in a short time. This method of fabrication takes less time and money and saves on materials compared to CAD/CAM. Although it seems that digital manufacturing technology has made great changes in the restorative dentistry field, this technology is still not fully in use. This is possibly because of the lack of studies and research on this technology, particularly in terms of clinical performance and patient-centred outcomes. 3D printing technologies are novel technologies with a lack of research; therefore, the processing of 3D printing materials is still controversial. | Other | 3D printed onlays |
Primary outcome
Fracture
Time frame: One Year
This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted
7 secondary outcomes
Retention
Time frame: One Year
Marginal adaptation
Time frame: One Year
Marginal discoloration
Time frame: One Year
Secondary caries
Time frame: One Year
Post-operative hypersensitivity
Time frame: One Year
Surface texture
Time frame: One Year
Anatomic form
Time frame: One Year
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 14 Jan 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.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/Cam milled onlays and 3D printed onlays in people with Badly Decayed Molars, run by Cairo University.
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 7 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: opening soon, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Contact Nada Sameh assistant lecturer (00201065228277, nada.farouk@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture (time frame: One Year). 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 14 Jan 2025.