Caries,DentalNCT05943782
Evaluation of CAD/CAM Onlays Fabricated by Subtractive Versus Additive Digital Manufacturing Techniques.
A study testing onlay manufactured by milling and Onlay manufactured by 3D printing in people with Caries,Dental and Broken Teeth, run by Ain Shams University at 1 site in Egypt.
Trial summary
Aim of the study: The aim of this RCT is to evaluate CAD/CAM onlays fabricated by subtractive technique (brilliant crios) versus additive technique (varseosmile crown plus material), in terms of clinical functional evaluation following the FDI criteria and three-dimensional digital evaluation of the marginal and… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental, Broken Teeth, Fracture Tooth
- What is being tested?
- onlay manufactured by milling and Onlay manufactured by 3D printing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2024to 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of caries lesion, defective amalgam, or composite restorations in posterior dentition (molars), suitable for the restoration with ceramic onlays.
- Presence of antagonist tooth.
- Adult patients (age: 18-50 years) of both genders.
- Good general and oral health; Able to tolerate necessary restorative procedures and willing to sign an informed consent.
- Absence of orthodontic appliances.
- Absence of malocclusion and tooth malformation.
Who cannot join
- Presence of non-carious cervical lesions.
- Pregnant women.
- Allergy to any of the restorative materials.
- Mobile teeth, indicating periodontal disease or trauma.
- External or internal resorption.
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: Functional Evaluation of CAD/CAM Onlays Fabricated by Subtractive Versus Additive Digital Manufacturing Techniques. A One Year Randomized Clinical Trial.
Aim of the study: The aim of this RCT is to evaluate CAD/CAM onlays fabricated by subtractive technique (brilliant crios) versus additive technique (varseosmile crown plus material), in terms of clinical functional evaluation following the FDI criteria and three-dimensional digital evaluation of the marginal and internal fit by triple scan protocol.
Materials and methods: A total of 30 patients will be enrolled in the clinical trial following the eligibility criteria. Then, the patients will be randomly allocated to receive either 3D printed onlays or milled ones. A blinded operator will prepare a standardized cavity for the restoration and an impression will be performed. After designing the restoration on the Exocad software, A dentist not involved in the clinical part of the study will receive the STL file of the design and envelopes containing the information necessary only to manufacture the restorations (tooth numbers and restorative materials) to proceed with either the milling or printing procedures. Try in and cementation procedures will be similarly performed for both groups by a blinded operator. Finally, the marginal and internal fit will be evaluated by using the triple scan protocol for digital 3D assessment.
Also, a baseline, six months and 12 months assessments will be performed by a blinded examiner, not involved in the clinical part for assessing the functional clinical performance of the re3stprations using the FDI criteria. Finally, the data will be statistically analyzed.
Read the detailed description
Statement of the problem: Several randomized clinical trials (RCT) investigated the clinical performance of milled ceramic and composite posterior indirect adhesive restorations. However, none investigated that of 3D printed ones and the differences in their fabrication process and material properties of these restorations may impact their clinical performance. Therefore, clinical assessment of that novel additive technique is required.
Aim of the study: The aim of this RCT is to evaluate CAD/CAM onlays fabricated by subtractive technique (brilliant crios) versus additive technique (varseosmile crown plus material), in terms of clinical functional evaluation following the FDI criteria and three-dimensional digital evaluation of the marginal and internal fit by triple scan protocol.
Materials and methods: A total of 30 patients will be enrolled in the clinical trial following the eligibility criteria. Then, the patients will be randomly allocated to receive either 3D printed onlays or milled ones. A blinded operator will prepare a standardized cavity for the restoration and an impression will be performed. After designing the restoration on the Exocad software, A dentist not involved in the clinical part of the study will receive the STL file of the design and envelopes containing the information necessary only to manufacture the restorations (tooth numbers and restorative materials) to proceed with either the milling or printing procedures. Try in and cementation procedures will be similarly performed for both groups by a blinded operator. Finally, the marginal and internal fit will be evaluated by using the triple scan protocol for digital 3D assessment.
Also, a baseline, six months and 12 months assessments will be performed by a blinded examiner, not involved in the clinical part for assessing the functional clinical performance of the re3stprations using the FDI criteria. Finally, the data will be statistically analyzed.
- Conditions
- Caries,Dental, Broken Teeth, Fracture Tooth, Defective Dentition
- Being tested
- onlay manufactured by milling, Onlay manufactured by 3D printing
- Medical subject headings
- Dental Caries, Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onlay manufactured by millingProcedure or surgery
indirect restorations for treating mutilated molars manufactured by CAD/CAM subtractive technique
Onlay manufactured by 3D printingProcedure or surgery
indirect restorations for treating mutilated molars manufactured by CAD/CAM additive technique
| Study group | Role | What they receive |
|---|---|---|
| additive manufacturing of onlays | Experimental | additive CAD/CAM manufacturing of dental restorations by 3D printing Receives: Procedure: Onlay manufactured by 3D printing |
| subtractive manufacturing of onlays | Active comparator | subtractive CAD/CAM manufacturing of dental restorations by milling Receives: Procedure: onlay manufactured by milling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal and internal fit.
three-dimensional digital evaluation by triple scan protocol in microns
Measured: Immediate after treatment
Secondary outcomes (1)
clinical functional evaluation .
clinical functional evaluation following the FDI criteria by clinical examination performed by trained investigators
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 posted13 Jul 2023
- Study start10 Sep 2024
- Primary completion1 Dec 2026 (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 Caries,DentalStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943782
- Sponsor's protocol ID
- 052308
- Status last verified
- Apr 2026
- First submitted
- 6 Jul 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Evaluation of CAD/CAM Onlays Fabricated by Subtractive Versus Additive Digital Manufacturing Techniques. A One Year Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05943782
- Acronym / sponsor ID
- 052308
- Conditions
- Caries,Dental, Broken Teeth, Fracture Tooth, Defective Dentition
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Jul 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.
Aim of the study: The aim of this RCT is to evaluate CAD/CAM onlays fabricated by subtractive technique (brilliant crios) versus additive technique (varseosmile crown plus material), in terms of clinical functional evaluation following the FDI criteria and three-dimensional digital evaluation of the marginal and internal fit by triple scan protocol.
Materials and methods: A total of 30 patients will be enrolled in the clinical trial following the eligibility criteria. Then, the patients will be randomly allocated to receive either 3D printed onlays or milled ones. A blinded operator will prepare a standardized cavity for the restoration and an impression will be performed. After designing the restoration on the Exocad software, A dentist not involved in the clinical part of the study will receive the STL file of the design and envelopes containing the information necessary only to manufacture the restorations (tooth numbers and restorative materials) to proceed with either the milling or printing procedures. Try in and cementation procedures will be similarly performed for both groups by a blinded operator. Finally, the marginal and internal fit will be evaluated by using the triple scan protocol for digital 3D assessment.
Also, a baseline, six months and 12 months assessments will be performed by a blinded examiner, not involved in the clinical part for assessing the functional clinical performance of the re3stprations using the FDI criteria. Finally, the data will be statistically analyzed.
Detailed description
Statement of the problem: Several randomized clinical trials (RCT) investigated the clinical performance of milled ceramic and composite posterior indirect adhesive restorations. However, none investigated that of 3D printed ones and the differences in their fabrication process and material properties of these restorations may impact their clinical performance. Therefore, clinical assessment of that novel additive technique is required.
Aim of the study: The aim of this RCT is to evaluate CAD/CAM onlays fabricated by subtractive technique (brilliant crios) versus additive technique (varseosmile crown plus material), in terms of clinical functional evaluation following the FDI criteria and three-dimensional digital evaluation of the marginal and internal fit by triple scan protocol.
Materials and methods: A total of 30 patients will be enrolled in the clinical trial following the eligibility criteria. Then, the patients will be randomly allocated to receive either 3D printed onlays or milled ones. A blinded operator will prepare a standardized cavity for the restoration and an impression will be performed. After designing the restoration on the Exocad software, A dentist not involved in the clinical part of the study will receive the STL file of the design and envelopes containing the information necessary only to manufacture the restorations (tooth numbers and restorative materials) to proceed with either the milling or printing procedures. Try in and cementation procedures will be similarly performed for both groups by a blinded operator. Finally, the marginal and internal fit will be evaluated by using the triple scan protocol for digital 3D assessment.
Also, a baseline, six months and 12 months assessments will be performed by a blinded examiner, not involved in the clinical part for assessing the functional clinical performance of the re3stprations using the FDI criteria. Finally, the data will be statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| additive manufacturing of onlays | Experimental | Procedure: Onlay manufactured by 3D printingadditive CAD/CAM manufacturing of dental restorations by 3D printing |
| subtractive manufacturing of onlays | Active comparator | Procedure: onlay manufactured by millingsubtractive CAD/CAM manufacturing of dental restorations by milling |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Presence of caries lesion, defective amalgam, or composite restorations in posterior dentition (molars), suitable for the restoration with ceramic onlays.
- Presence of antagonist tooth.
- Adult patients (age: 18-50 years) of both genders.
- Good general and oral health; Able to tolerate necessary restorative procedures and willing to sign an informed consent.
- Absence of orthodontic appliances.
Key exclusion criteria (5 listed)
- Presence of non-carious cervical lesions.
- Pregnant women.
- Allergy to any of the restorative materials.
- Mobile teeth, indicating periodontal disease or trauma.
- External or internal resorption.
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 |
|---|---|---|
| onlay manufactured by millingindirect restorations for treating mutilated molars manufactured by CAD/CAM subtractive technique | Procedure or surgery | subtractive manufacturing of onlays |
| Onlay manufactured by 3D printingindirect restorations for treating mutilated molars manufactured by CAD/CAM additive technique | Procedure or surgery | additive manufacturing of onlays |
Primary outcome
Marginal and internal fit.
Time frame: Immediate after treatment
three-dimensional digital evaluation by triple scan protocol in microns
1 secondary outcome
clinical functional evaluation .
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 6 Apr 2026.
- Individual participant dataSharing planned: No
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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 onlay manufactured by milling and Onlay manufactured by 3D printing in people with Caries,Dental and Broken Teeth, run by Ain Shams 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 6 inclusion and 5 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 6 Apr 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. 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?
Marginal and internal fit. (time frame: Immediate after treatment). 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 6 Apr 2026.