3D-PrintedNCT07861659
Clinical Evaluation of 3D-Printed Versus Direct Composite Restorations in Class II Cavities
A study testing PG4 Dentsprint 3D-printed composite resin and Filtek P60 (3M) Packable composite in people with 3D-Printed and Direct Composite, 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 composites compared to direct conventional composite restorations in Class II cavities Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- 3D-Printed, Direct Composite, Resin Restorations
- What is being tested?
- PG4 Dentsprint 3D-printed composite resin and Filtek P60 (3M) Packable composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 26 May 2026to 30 Nov 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have at least two Class II carious lesions corresponded to ICDAS scores 4 and 5, representing dentinal caries suitable for operative restorative treatment.
- The absence of ongoing orthodontic treatment or use of prostheses.
- Good general health without relevant disease.
Who cannot join
- Uncooperative patient.
- Any parafunctional habits such as tooth clenching or grinding.
- Chronic pulmonary diseases and blocked nasal passages.
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
aculty of Dentistry, Tanta University, Tanta, Tanta 31527
Tanta, Egypt, 31511
About this study
The aim of this study is to clinically evaluate the performance of 3D-printed composites compared to direct conventional composite restorations in Class II cavities
Read the detailed description
Resin-based composites are widely used for posterior restorations because of their esthetics, adhesion, and conservative preparation. However, Class II restorations remain challenging due to polymerization shrinkage, marginal gaps, postoperative sensitivity, and inadequate proximal contacts. Digital additive manufacturing has emerged as a promising approach, offering precise fabrication, reduced material waste, and customizable restorations. Although laboratory studies suggest favorable mechanical properties and marginal adaptation, clinical evidence for 3D-printed intracoronal restorations remains limited. Therefore, this randomized clinical trial will compare the clinical performance of 3D-printed composite inlays with conventional direct composite restorations in Class II cavities over 24 months.
- Conditions
- 3D-Printed, Direct Composite, Resin Restorations
- Being tested
- PG4 Dentsprint 3D-printed composite resin, Filtek P60 (3M) Packable composite
- Keywords
- Class II Cavities, Clinical, Evaluation, 3D-Printed, Direct Composite, Resin Restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG4 Dentsprint 3D-printed composite resinOther
Class II cavities will be restored with digitally designed and 3D-printed permanent composite inlays. The restorations will be post-cured and adhesively cemented according to the material manufacturer's recommendations
Filtek P60 (3M) Packable compositeOther
Class II cavities will be restored directly using a conventional light-cured resin-based composite placed with a standardized incremental technique and adhesive protocol
| Study group | Role | What they receive |
|---|---|---|
| 3D-Printed Composite Inlays | Experimental | Participants will receive Class II restorations fabricated from a commercially available 3D-printable permanent composite resin using a standardized digital workflow. The restorations will be adhesively bonded to the prepared cavities according to the manufacturer's instructions. Receives: Other: PG4 Dentsprint 3D-printed composite resin |
| Direct Composite Restorations | Active comparator | Participants will receive conventional direct Class II restorations using a commercially available resin-based composite. Restorations will be placed incrementally using a standardized adhesive protocol and light-curing procedure according to the manufacturer's recommendations. Both groups will be clinically evaluated at baseline and during the 18-month follow-up period using standardized clinical criteria. Receives: Other: Filtek P60 (3M) Packable composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture and retention
Description: Clinical evaluation of fracture and retentin was conducted in accordance with the World Dental Federation (FDI) criteria by two calibrated examiners at baseline and after 6, 12, and 18 months. Each restoration was evaluated according to the degree of conformity with the established criteria as follows: score 1, excellent; scores 2 and 3, satisfactory; and scores 4 and 5, inadequate. Scores of 1-3 were considered indicative of clinical success, whereas scores of 4 or 5 were considered indicative of failure.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start26 May 2026
- Primary completion28 Nov 2027 (estimated)
- Study completion30 Nov 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 3D-PrintedStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 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
- NCT07861659
- Sponsor's protocol ID
- 3D-Printed & Direct Composite
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duarte S Jr, Phark JH. Advances in Dental Restorations: A Comprehensive Review of Machinable and 3D-Printed Ceramic-Reinforced Composites. J Esthet Restor Dent. 2025 Jan;37(1):257-276. doi: 10.1111/jerd.13371. Epub 2024 Nov 18.
PubMed 39558703Tanaka LEB, da Silva Rodrigues C, Grangeiro MTV, Campos TMB, de Melo RM. Characterization of 3D printed composite for final dental restorations. Clin Oral Investig. 2024 Oct 31;28(11):617. doi: 10.1007/s00784-024-06003-8.
PubMed 39480538Peskersoy C, Oguzhan A. Evaluation of the Mechanical and Adhesion Characteristics of Indirect Restorations Manufactured with Three-Dimensional Printing. Polymers (Basel). 2024 Feb 23;16(5):613. doi: 10.3390/polym16050613.
PubMed 38475296Balestra D, Lowther M, Goracci C, Mandurino M, Cortili S, Paolone G, Louca C, Vichi A. 3D Printed Materials for Permanent Restorations in Indirect Restorative and Prosthetic Dentistry: A Critical Review of the Literature. Materials (Basel). 2024 Mar 18;17(6):1380. doi: 10.3390/ma17061380.
PubMed 38541534
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 3D-Printed Versus Direct Composite Restorations in Class II Cavities
- ClinicalTrials.gov ID
- NCT07861659
- Acronym / sponsor ID
- 3D-Printed & Direct Composite
- Conditions
- 3D-Printed, Direct Composite, Resin Restorations
- Keywords
- Class II Cavities, Clinical, Evaluation, 3D-Printed, Direct Composite, Resin Restorations
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- 28 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 6 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 composites compared to direct conventional composite restorations in Class II cavities
Detailed description
Resin-based composites are widely used for posterior restorations because of their esthetics, adhesion, and conservative preparation. However, Class II restorations remain challenging due to polymerization shrinkage, marginal gaps, postoperative sensitivity, and inadequate proximal contacts. Digital additive manufacturing has emerged as a promising approach, offering precise fabrication, reduced material waste, and customizable restorations. Although laboratory studies suggest favorable mechanical properties and marginal adaptation, clinical evidence for 3D-printed intracoronal restorations remains limited. Therefore, this randomized clinical trial will compare the clinical performance of 3D-printed composite inlays with conventional direct composite restorations in Class II cavities over 24 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-Printed Composite Inlays | Experimental | Other: PG4 Dentsprint 3D-printed composite resinParticipants will receive Class II restorations fabricated from a commercially available 3D-printable permanent composite resin using a standardized digital workflow. The restorations will be adhesively bonded to the prepared cavities according to the manufacturer's instructions. |
| Direct Composite Restorations | Active comparator | Other: Filtek P60 (3M) Packable compositeParticipants will receive conventional direct Class II restorations using a commercially available resin-based composite. Restorations will be placed incrementally using a standardized adhesive protocol and light-curing procedure according to the manufacturer's recommendations. Both groups will be clinically evaluated at baseline and during the 18-month follow-up period using standardized clinical criteria. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have at least two Class II carious lesions corresponded to ICDAS scores 4 and 5, representing dentinal caries suitable for operative restorative treatment.
- The absence of ongoing orthodontic treatment or use of prostheses.
- Good general health without relevant disease.
Key exclusion criteria (3 listed)
- Uncooperative patient.
- Any parafunctional habits such as tooth clenching or grinding.
- Chronic pulmonary diseases and blocked nasal passages.
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 |
|---|---|---|
| PG4 Dentsprint 3D-printed composite resinClass II cavities will be restored with digitally designed and 3D-printed permanent composite inlays. The restorations will be post-cured and adhesively cemented according to the material manufacturer's recommendations | Other | 3D-Printed Composite Inlays |
| Filtek P60 (3M) Packable compositeClass II cavities will be restored directly using a conventional light-cured resin-based composite placed with a standardized incremental technique and adhesive protocol | Other | Direct Composite Restorations |
Primary outcome
Fracture and retention
Time frame: 18 months
Description: Clinical evaluation of fracture and retentin was conducted in accordance with the World Dental Federation (FDI) criteria by two calibrated examiners at baseline and after 6, 12, and 18 months. Each restoration was evaluated according to the degree of conformity with the established criteria as follows: score 1, excellent; scores 2 and 3, satisfactory; and scores 4 and 5, inadequate. Scores of 1-3 were considered indicative of clinical success, whereas scores of 4 or 5 were considered indicative of failure.
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 Oct 2026.
- Results publication: PubMed 39558703Duarte S Jr, Phark JH. Advances in Dental Restorations: A Comprehensive Review of Machinable and 3D-Printed Ceramic-Reinforced Composites. J Esthet Restor Dent. 2025 Jan;37(1):257-276. doi: 10.1111/jerd.13371. Epub 2024 Nov 18.
- Results publication: PubMed 39480538Tanaka LEB, da Silva Rodrigues C, Grangeiro MTV, Campos TMB, de Melo RM. Characterization of 3D printed composite for final dental restorations. Clin Oral Investig. 2024 Oct 31;28(11):617. doi: 10.1007/s00784-024-06003-8.
- Results publication: PubMed 38475296Peskersoy C, Oguzhan A. Evaluation of the Mechanical and Adhesion Characteristics of Indirect Restorations Manufactured with Three-Dimensional Printing. Polymers (Basel). 2024 Feb 23;16(5):613. doi: 10.3390/polym16050613.
- Results publication: PubMed 38541534Balestra D, Lowther M, Goracci C, Mandurino M, Cortili S, Paolone G, Louca C, Vichi A. 3D Printed Materials for Permanent Restorations in Indirect Restorative and Prosthetic Dentistry: A Critical Review of the Literature. Materials (Basel). 2024 Mar 18;17(6):1380. doi: 10.3390/ma17061380.
- 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 PG4 Dentsprint 3D-printed composite resin and Filtek P60 (3M) Packable composite in people with 3D-Printed and Direct Composite, 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 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: enrolling by invitation, as of the sponsor's last update on 6 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 and retention (time frame: 18 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 NCT07861659, 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 6 Oct 2026.