Class II LesionsNCT07429747
Performance of Reinforced 3D-Printed Versus Direct Bulk-Filled Resin Composites for Restoring Extensive Class II Cavities in Vital Molars
A study testing 3D-printed Ceramic reinforced resin restoration and bulk fill composite in people with Class II Lesions and 3D Printing, run by Ahmed Reda Abd EL Rahman.
Trial summary
Most published research on 3D-printed restorative materials is laboratory-based, focusing primarily on mechanical performance and material properties under controlled conditions. While such studies provide important foundational data, they do not fully replicate the complexity of the oral environment. Read more about this study
- Who is it for?
- Ages 22 to 45 years
- Conditions the study is for
- Class II Lesions, 3D Printing, Bulk Fill
- What is being tested?
- 3D-printed Ceramic reinforced resin restoration and bulk fill composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2026to 1 Oct 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 22 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient-related:
- Adults aged 22 to 45 years.
- Low to moderate caries risk.
- Normal occlusion.
- No signs or symptoms of temporomandibular joint disorders.
- Satisfactory oral hygiene.
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- Medically fit to receive routine restorative dental treatment.
- Lesion-related:
- Permanent molar requiring a compound Class II restoration.
- Primary carious lesion classified as ICDAS score 5.
- Presence of an adjacent tooth and a sound opposing tooth in occlusion.
- No clinical signs or symptoms of irreversible pulpitis in the involved, adjacent, or opposing teeth.
- No radiographic evidence of periapical pathology.
Who cannot join
- Patient-related:
- Bruxism.
- Poor cooperation.
- Inability or unwillingness to attend follow-up visits.
- Anticipated travel during the study period.
- Poor oral hygiene.
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- Chronic or advanced periodontitis.
- Known allergy to any study materials.
- Pregnant or breastfeeding women.
- Lesion-related:
- Teeth with visible fractures or cracks.
- Rampant caries.
- Defective restorations on adjacent or opposing teeth.
- Atypical extrinsic staining that may interfere with evaluation.
- Radiographic signs of apical pathology.
About this study
Official title: Performance of Reinforced 3D-Printed Versus Direct Bulk-Filled Resin Composites for Restoring Extensive Class II Cavities in Vital Molars: A Randomized Clinical Trial
Most published research on 3D-printed restorative materials is laboratory-based, focusing primarily on mechanical performance and material properties under controlled conditions. While such studies provide important foundational data, they do not fully replicate the complexity of the oral environment. Only a limited number of clinical investigations have directly compared 3D-printed restorations with conventional direct composite restorations in Class II cavities Furthermore, the integration of a digital workflow introduces additional costs and time requirements related to equipment, software, and training. These factors must be justified by demonstrable improvements in clinical outcomes or cost-effectiveness. By evaluating both clinical performance and economic impact, this trial aims to generate practical, real-world evidence that can guide clinicians in selecting appropriate restorative materials and techniques for routine dental practice.
- Conditions
- Class II Lesions, 3D Printing, Bulk Fill, Proximal Cavities of Posterior Teeth, Composite Restorations
- Being tested
- 3D-printed Ceramic reinforced resin restoration, bulk fill composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed Ceramic reinforced resin restorationOther
Tooth preparation for indirect inlay restorations follows conservative restorative principles, with the primary objective of eliminating carious tissue and unsupported enamel while preserving as much healthy tooth structure as possible. The preparation design emphasizes mechanical stability, stress distribution, and optimal seating of the final restoration. Cavity walls are shaped with a slight occlusal divergence of approximately 6-10°, facilitating proper insertion and seating of the inlay without compromising retention. The pulpal floor is prepared flat to enhance resistance form, and all internal line angles are rounded to minimize stress concentration within both the tooth and the restorative material. Cavosurface margins are ideally prepared as supragingival butt-joint margins whenever clinically feasible, promoting periodontal health, improved isolation, and easier finishing procedures.
Cuspal coverage is generally avoided in inlay preparations to maintain maximum tooth integrit
bulk fill compositeOther
For restoration of Class II cavity preparations, a sectional metal matrix system (TOR VM, Russia) will be used to properly reestablish proximal anatomy and contact. The system includes a round separation ring and a pre-contoured metal band designed to reproduce natural proximal contours. A properly sized wedge is inserted to ensure optimal gingival adaptation of the matrix band and to prevent overhangs. The cavity is thoroughly rinsed with water before proceeding with adhesive procedures.
Selective enamel etching is performed using 37% phosphoric acid gel applied to enamel margins for 15 seconds, followed by thorough rinsing and gentle air-drying. A universal adhesive system, Tetric N-Bond Universal (Ivoclar Vivadent AG), is then applied in two consecutive layers. Each layer is actively rubbed for 10 seconds, gently air-dried for 5 seconds, and light-cured for 20 seconds to ensure adequate polymerization and bond strength.
Restoration is completed using Tetric N-Ceram Bulk Fill resin c
| Study group | Role | What they receive |
|---|---|---|
| Bulk-filled resin composite | Active comparator | For restoration of Class II cavity preparations, a sectional metal matrix system (TOR VM, Russia) will be used to properly reestablish proximal anatomy and contact. The system includes a round separation ring and a pre-contoured metal band designed to reproduce natural proximal contours. A properly sized wedge is inserted to ensure optimal gingival adaptation of the matrix band and to prevent overhangs. The cavity is thoroughly rinsed with water before proceeding with adhesive procedures.
Selective enamel etching is performed using 37% phosphoric acid gel applied to enamel margins for 15 seconds, followed by thorough rinsing and gentle air-drying. A universal adhesive system, Tetric N-Bond Universal (Ivoclar Vivadent AG), is then applied in two consecutive layers. Each layer is actively rubbed for 10 seconds, gently air-dried for 5 seconds, and light-cured for 20 seconds to ensure adequate polymerization and bond strength.
Restoration is completed using Tetric N-Ceram Bulk Fill resin Receives: Other: bulk fill composite |
| 3D-printed Ceramic reinforced resin restoration | Experimental | Tooth preparation for indirect inlay restorations follows conservative restorative principles, with the primary objective of eliminating carious tissue and unsupported enamel while preserving as much healthy tooth structure as possible. The preparation design emphasizes mechanical stability, stress distribution, and optimal seating of the final restoration. Cavity walls are shaped with a slight occlusal divergence of approximately 6-10°, facilitating proper insertion and seating of the inlay without compromising retention. The pulpal floor is prepared flat to enhance resistance form, and all internal line angles are rounded to minimize stress concentration within both the tooth and the restorative material. Cavosurface margins are ideally prepared as supragingival butt-joint margins whenever clinically feasible, promoting periodontal health, improved isolation, and easier finishing procedures. Receives: Other: 3D-printed Ceramic reinforced resin restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a change in functional properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
Fracture of material, retention of the restoration, marginal adaptation, occlusal wear, proximal contact utilizing visual examination and radiographic assessment.
For each criterion, one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).
Measured: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
Number of participants with a change in Biological properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
(Postoperative hypersensitivity \& tooth vitality, Recurrence of caries, erosion \& abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth), Adjacent mucosa, Oral \& general health) utilizing visual examination.
For each criterion, one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).
Measured: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
Number of participants with a change in Esthetic properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
(Surface luster, Staining (surface \&margin),Color match \& translucency \& Esthetic anatomical form) utilizing visual examination
For each criterion, one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).
Measured: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start20 Feb 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Class II LesionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Reda Abd EL Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Reda Abd EL Rahman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429747
- Sponsor's protocol ID
- Cons334
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdelaziz MM, Fathy S, Alaraby AA, Shehab WI, Temirek MM. Clinical, radiographic and biochemical assessment of proximal cavities restored with composite resin using incremental vs. bulk packing techniques: One-year randomized clinical trial. BMC Oral Health. 2024 Sep 30;24(1):1162. doi: 10.1186/s12903-024-04746-0.
PubMed 39350180Duarte 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 39558703Balestra 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Reinforced 3D-Printed Versus Direct Bulk-Filled Resin Composites for Restoring Extensive Class II Cavities in Vital Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07429747
- Acronym / sponsor ID
- Cons334
- Conditions
- Class II Lesions, 3D Printing, Bulk Fill, Proximal Cavities of Posterior Teeth, Composite Restorations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ahmed Reda Abd EL RahmanUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 24 Feb 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.
Most published research on 3D-printed restorative materials is laboratory-based, focusing primarily on mechanical performance and material properties under controlled conditions. While such studies provide important foundational data, they do not fully replicate the complexity of the oral environment. Only a limited number of clinical investigations have directly compared 3D-printed restorations with conventional direct composite restorations in Class II cavities Furthermore, the integration of a digital workflow introduces additional costs and time requirements related to equipment, software, and training. These factors must be justified by demonstrable improvements in clinical outcomes or cost-effectiveness. By evaluating both clinical performance and economic impact, this trial aims to generate practical, real-world evidence that can guide clinicians in selecting appropriate restorative materials and techniques for routine dental practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bulk-filled resin composite | Active comparator | Other: bulk fill compositeFor restoration of Class II cavity preparations, a sectional metal matrix system (TOR VM, Russia) will be used to properly reestablish proximal anatomy and contact. The system includes a round separation ring and a pre-contoured metal band designed to reproduce natural proximal contours. A properly sized wedge is inserted to ensure optimal gingival adaptation of the matrix band and to prevent overhangs. The cavity is thoroughly rinsed with water before proceeding with adhesive procedures. Selective enamel etching is performed using 37% phosphoric acid gel applied to enamel margins for 15 seconds, followed by thorough rinsing and gentle air-drying. A universal adhesive system, Tetric N-Bond Universal (Ivoclar Vivadent AG), is then applied in two consecutive layers. Each layer is actively rubbed for 10 seconds, gently air-dried for 5 seconds, and light-cured for 20 seconds to ensure adequate polymerization and bond strength. Restoration is completed using Tetric N-Ceram Bulk Fill resin |
| 3D-printed Ceramic reinforced resin restoration | Experimental | Other: 3D-printed Ceramic reinforced resin restorationTooth preparation for indirect inlay restorations follows conservative restorative principles, with the primary objective of eliminating carious tissue and unsupported enamel while preserving as much healthy tooth structure as possible. The preparation design emphasizes mechanical stability, stress distribution, and optimal seating of the final restoration. Cavity walls are shaped with a slight occlusal divergence of approximately 6-10°, facilitating proper insertion and seating of the inlay without compromising retention. The pulpal floor is prepared flat to enhance resistance form, and all internal line angles are rounded to minimize stress concentration within both the tooth and the restorative material. Cavosurface margins are ideally prepared as supragingival butt-joint margins whenever clinically feasible, promoting periodontal health, improved isolation, and easier finishing procedures. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Adults aged 22 to 45 years.
- Low to moderate caries risk.
- Normal occlusion.
- No signs or symptoms of temporomandibular joint disorders.
- Satisfactory oral hygiene.
Key exclusion criteria (15 listed)
- Bruxism.
- Poor cooperation.
- Inability or unwillingness to attend follow-up visits.
- Anticipated travel during the study period.
- Poor oral hygiene.
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 Ceramic reinforced resin restorationTooth preparation for indirect inlay restorations follows conservative restorative principles, with the primary objective of eliminating carious tissue and unsupported enamel while preserving as much healthy tooth structure as possible. The preparation design emphasizes mechanical stability, stress distribution, and optimal seating of the final restoration. Cavity walls are shaped with a slight occlusal divergence of approximately 6-10°, facilitating proper insertion and seating of the inlay without compromising retention. The pulpal floor is prepared flat to enhance resistance form, and all internal line angles are rounded to minimize stress concentration within both the tooth and the restorative material. Cavosurface margins are ideally prepared as supragingival butt-joint margins whenever clinically feasible, promoting periodontal health, improved isolation, and easier finishing procedures. Cuspal coverage is generally avoided in inlay preparations to maintain maximum tooth integrit | Other | 3D-printed Ceramic reinforced resin restoration |
| bulk fill compositeFor restoration of Class II cavity preparations, a sectional metal matrix system (TOR VM, Russia) will be used to properly reestablish proximal anatomy and contact. The system includes a round separation ring and a pre-contoured metal band designed to reproduce natural proximal contours. A properly sized wedge is inserted to ensure optimal gingival adaptation of the matrix band and to prevent overhangs. The cavity is thoroughly rinsed with water before proceeding with adhesive procedures. Selective enamel etching is performed using 37% phosphoric acid gel applied to enamel margins for 15 seconds, followed by thorough rinsing and gentle air-drying. A universal adhesive system, Tetric N-Bond Universal (Ivoclar Vivadent AG), is then applied in two consecutive layers. Each layer is actively rubbed for 10 seconds, gently air-dried for 5 seconds, and light-cured for 20 seconds to ensure adequate polymerization and bond strength. Restoration is completed using Tetric N-Ceram Bulk Fill resin c | Other | Bulk-filled resin composite |
Primary outcome
Number of participants with a change in functional properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
Time frame: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
Fracture of material, retention of the restoration, marginal adaptation, occlusal wear, proximal contact utilizing visual examination and radiographic assessment. For each criterion, one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).
Number of participants with a change in Biological properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
Time frame: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
(Postoperative hypersensitivity \& tooth vitality, Recurrence of caries, erosion \& abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth), Adjacent mucosa, Oral \& general health) utilizing visual examination. For each criterion, one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).
Number of participants with a change in Esthetic properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
Time frame: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
(Surface luster, Staining (surface \&margin),Color match \& translucency \& Esthetic anatomical form) utilizing visual examination For each criterion, one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory \& poor).
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 4 Mar 2026.
- Results publication: PubMed 39350180Abdelaziz MM, Fathy S, Alaraby AA, Shehab WI, Temirek MM. Clinical, radiographic and biochemical assessment of proximal cavities restored with composite resin using incremental vs. bulk packing techniques: One-year randomized clinical trial. BMC Oral Health. 2024 Sep 30;24(1):1162. doi: 10.1186/s12903-024-04746-0.
- 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 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: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed Ceramic reinforced resin restoration and bulk fill composite in people with Class II Lesions and 3D Printing, run by Ahmed Reda Abd EL Rahman.
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 13 inclusion and 15 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 4 Mar 2026. 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?
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?
Number of participants with a change in functional properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations (time frame: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.). The study lists 3 primary outcomes in all. 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 NCT07429747, which also lists 3 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 4 Mar 2026.