CAD/CAMNCT07853118
Clinical Evaluation of 3D-Printed Resin Versus CAD/CAM-Milled Lithium Disilicate Overlay Restorations
A study testing 3D-printed ODYX-CR ceramic-filled resin and CAD/CAM-milled lithium disilicate ceramic in people with CAD/CAM and 3D-printed, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to clinically evaluate the performance of 3D-printed resin and CAD/CAM lithium disilicate overlay restorations. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- CAD/CAM, 3D-printed, Lithium Disilicate
- What is being tested?
- 3D-printed ODYX-CR ceramic-filled resin and CAD/CAM-milled lithium disilicate ceramic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jul 2026to 10 Aug 2027
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health.
- Good oral hygiene.
- Molars requiring overlay restorations with at least one cusp thickness ≤2 mm
Who cannot join
- Bruxism or parafunctional habits.
- Severe periodontal disease.
- Pregnancy or lactation.
- Severe malocclusion
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
Restorative Department, Faculty of Dentistry, Tanta University
Tanta, Tanta, 31527
About this study
The aim of this study is to clinically evaluate the performance of 3D-printed resin and CAD/CAM lithium disilicate overlay restorations.
Read the detailed description
Overlay restorations provide cuspal coverage while preserving cervical tooth structure and maximizing the remaining enamel available for adhesive bonding. Their conservative preparation makes them increasingly suitable for restoring extensively damaged posterior teeth while maintaining sound tooth tissue. Lithium disilicate glass-ceramic is widely used for indirect restorations because of its favorable mechanical strength, durability, and esthetic properties. However, conventional CAD/CAM milling is a subtractive process that removes material from prefabricated blocks, resulting in considerable material waste. Additive manufacturing, or three-dimensional (3D) printing, has emerged as an alternative approach that fabricates restorations layer by layer directly from digital designs. Unlike milling, 3D printing deposits material selectively according to the planned restoration, reducing waste and potentially improving manufacturing efficiency while allowing accurate reproduction of complex anatomical structures.
- Conditions
- CAD/CAM, 3D-printed, Lithium Disilicate, Overlay Restorations
- Being tested
- 3D-printed ODYX-CR ceramic-filled resin, CAD/CAM-milled lithium disilicate ceramic
- Keywords
- Clinical, 3D-Printed, FDI criteria, Overlay, CAD/CAM, Restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed ODYX-CR ceramic-filled resinOther
The ODYX-CR restorations will be fabricated using digital light processing (DLP) 3D printing; restorations will be adhesively cemented using preheated resin composite following the respective manufacturer's recommended surface-treatment protocols. Clinical performance will be evaluated at baseline (24 hours), 6, 12, months using Fédération Dentaire Internationale (FDI) clinical criteria, including functional, biological, and esthetic properties.
CAD/CAM-milled lithium disilicate ceramicOther
The comparator restorations will be fabricated by milling lithium disilicate CAD/CAM blocks. Both restorations will be adhesively cemented using preheated resin composite following the respective manufacturer's recommended surface-treatment protocols. Clinical performance will be evaluated at baseline (24 hours), 6, 12, months using Fédération Dentaire Internationale (FDI) clinical criteria, including functional, biological, and esthetic properties.
| Study group | Role | What they receive |
|---|---|---|
| 3D-Printed Ceramic-Filled Resin Overlay | Experimental | Participants allocated to this group will receive posterior molar overlay restorations fabricated from ODYX-CR ceramic-filled composite resin using a digital light processing (DLP) three-dimensional printing workflow Receives: Other: 3D-printed ODYX-CR ceramic-filled resin |
| CAD/CAM-Milled Lithium Disilicate Overlay | Experimental | Participants allocated to this group will receive posterior molar overlay restorations fabricated from CAD/CAM-milled lithium disilicate ceramic blocks. Receives: Other: CAD/CAM-milled lithium disilicate ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture of restoration
Clinical evaluation of restorations using the FDI criteria. Scores 1-3 will be classified as clinically acceptable, whereas scores 4-5 will be classified as clinically unacceptable and requiring repair or replacement.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start26 Jul 2026
- Primary completion29 Jul 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CAD/CAMStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abd El Ghany Mohammed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853118
- Sponsor's protocol ID
- 3D-Printed Versus CAD/CAM
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelgawad AHY, Hamed NHM, Soliman ZDE, Kamel MA. Fracture resistance of structurally compromised maxillary premolars restored with different bulk-fill base materials and CAD/CAM milled and 3D printed hybrid composite overlays: an in vitro study. Odontology. 2026 May 13. doi: 10.1007/s10266-026-01404-5. Online ahead of print.
PubMed 42126495Sonkaya E, Zeliha Bek Kurklu G. Additively Manufactured Definitive Crown Resins on Premolar and Molar Teeth: 2-Year Results of a Prospective Clinical Study. Int J Prosthodont. 2025 May 21;38(3):279-289. doi: 10.11607/ijp.9200.
PubMed 39486004Rachiotis I, Pachiou A, Salem M, Karasan D, Sailer I, Rahiotis C. Three-Dimensional Printed Materials for Definitive Ceramic and Resin Restorations: A Scoping Review. Materials (Basel). 2026 Sep 1;19(17):3728. doi: 10.3390/ma19173728.
PubMed 42738164Alghauli MA, Alqutaibi AY. 3D-printed intracoronal restorations, occlusal and laminate veneers: Clinical relevance, properties, and behavior compared to milled restorations; a systematic review and meta-analysis. J Esthet Restor Dent. 2024 Aug;36(8):1153-1170. doi: 10.1111/jerd.13228. Epub 2024 Mar 29.
PubMed 38551205
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 3D-Printed Resin Versus CAD/CAM-Milled Lithium Disilicate Overlay Restorations
- ClinicalTrials.gov ID
- NCT07853118
- Acronym / sponsor ID
- 3D-Printed Versus CAD/CAM
- Conditions
- CAD/CAM, 3D-printed, Lithium Disilicate, Overlay Restorations
- Keywords
- Clinical, 3D-Printed, FDI criteria, Overlay, CAD/CAM, Restorations
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 26 Jul 2026 (actual)
- Primary completion
- 29 Jul 2027 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 1 Oct 2026 (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 this study is to clinically evaluate the performance of 3D-printed resin and CAD/CAM lithium disilicate overlay restorations.
Detailed description
Overlay restorations provide cuspal coverage while preserving cervical tooth structure and maximizing the remaining enamel available for adhesive bonding. Their conservative preparation makes them increasingly suitable for restoring extensively damaged posterior teeth while maintaining sound tooth tissue. Lithium disilicate glass-ceramic is widely used for indirect restorations because of its favorable mechanical strength, durability, and esthetic properties. However, conventional CAD/CAM milling is a subtractive process that removes material from prefabricated blocks, resulting in considerable material waste. Additive manufacturing, or three-dimensional (3D) printing, has emerged as an alternative approach that fabricates restorations layer by layer directly from digital designs. Unlike milling, 3D printing deposits material selectively according to the planned restoration, reducing waste and potentially improving manufacturing efficiency while allowing accurate reproduction of complex anatomical structures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-Printed Ceramic-Filled Resin Overlay | Experimental | Other: 3D-printed ODYX-CR ceramic-filled resinParticipants allocated to this group will receive posterior molar overlay restorations fabricated from ODYX-CR ceramic-filled composite resin using a digital light processing (DLP) three-dimensional printing workflow |
| CAD/CAM-Milled Lithium Disilicate Overlay | Experimental | Other: CAD/CAM-milled lithium disilicate ceramicParticipants allocated to this group will receive posterior molar overlay restorations fabricated from CAD/CAM-milled lithium disilicate ceramic blocks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good general health.
- Good oral hygiene.
- Molars requiring overlay restorations with at least one cusp thickness ≤2 mm
Key exclusion criteria (4 listed)
- Bruxism or parafunctional habits.
- Severe periodontal disease.
- Pregnancy or lactation.
- Severe malocclusion
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 |
|---|---|---|
| 3D-printed ODYX-CR ceramic-filled resinThe ODYX-CR restorations will be fabricated using digital light processing (DLP) 3D printing; restorations will be adhesively cemented using preheated resin composite following the respective manufacturer's recommended surface-treatment protocols. Clinical performance will be evaluated at baseline (24 hours), 6, 12, months using Fédération Dentaire Internationale (FDI) clinical criteria, including functional, biological, and esthetic properties. | Other | 3D-Printed Ceramic-Filled Resin Overlay |
| CAD/CAM-milled lithium disilicate ceramicThe comparator restorations will be fabricated by milling lithium disilicate CAD/CAM blocks. Both restorations will be adhesively cemented using preheated resin composite following the respective manufacturer's recommended surface-treatment protocols. Clinical performance will be evaluated at baseline (24 hours), 6, 12, months using Fédération Dentaire Internationale (FDI) clinical criteria, including functional, biological, and esthetic properties. | Other | CAD/CAM-Milled Lithium Disilicate Overlay |
Primary outcome
Fracture of restoration
Time frame: 12 months
Clinical evaluation of restorations using the FDI criteria. Scores 1-3 will be classified as clinically acceptable, whereas scores 4-5 will be classified as clinically unacceptable and requiring repair or replacement.
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 8 Oct 2026.
- Results publication: PubMed 42126495Abdelgawad AHY, Hamed NHM, Soliman ZDE, Kamel MA. Fracture resistance of structurally compromised maxillary premolars restored with different bulk-fill base materials and CAD/CAM milled and 3D printed hybrid composite overlays: an in vitro study. Odontology. 2026 May 13. doi: 10.1007/s10266-026-01404-5. Online ahead of print.
- Results publication: PubMed 39486004Sonkaya E, Zeliha Bek Kurklu G. Additively Manufactured Definitive Crown Resins on Premolar and Molar Teeth: 2-Year Results of a Prospective Clinical Study. Int J Prosthodont. 2025 May 21;38(3):279-289. doi: 10.11607/ijp.9200.
- Results publication: PubMed 42738164Rachiotis I, Pachiou A, Salem M, Karasan D, Sailer I, Rahiotis C. Three-Dimensional Printed Materials for Definitive Ceramic and Resin Restorations: A Scoping Review. Materials (Basel). 2026 Sep 1;19(17):3728. doi: 10.3390/ma19173728.
- Results publication: PubMed 38551205Alghauli MA, Alqutaibi AY. 3D-printed intracoronal restorations, occlusal and laminate veneers: Clinical relevance, properties, and behavior compared to milled restorations; a systematic review and meta-analysis. J Esthet Restor Dent. 2024 Aug;36(8):1153-1170. doi: 10.1111/jerd.13228. Epub 2024 Mar 29.
- 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 3D-printed ODYX-CR ceramic-filled resin and CAD/CAM-milled lithium disilicate ceramic in people with CAD/CAM and 3D-printed, run by Tanta 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 3 inclusion and 4 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 8 Oct 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?
Fracture of restoration (time frame: 12 months). 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 NCT07853118, which also lists 4 linked publications.
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 8 Oct 2026.