Prosthesis UserNCT07522671
Clinical Performance of 3D-Printed Resin and Zirconia Implant Restorations
A study testing 3D-Printed Resin Restoration (CROWNTEC) in people with Prosthesis User, run by Menoufia University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial evaluates the clinical performance of 3D-printed resin restorations compared with milled monolithic zirconia in implant-supported single crowns and short-span fixed partial dentures (FPDs). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prosthesis User
- What is being tested?
- 3D-Printed Resin Restoration (CROWNTEC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Nov 2028
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following:
- Age ≥18 years.
- Have one or two osseointegrated dental implants requiring prosthetic restoration.
- Demonstrate stable peri-implant tissues with no signs of inflammation or implant mobility.
- Maintain good oral hygiene and controlled periodontal status.
- Require either:
- A single implant-supported crown, or
- A short-span (maximum 3-unit) implant-supported fixed partial denture (FPD) supported by two implants in the mandibular anterior region.
Who cannot join
- Participants are excluded if they have any of the following:
- Severe parafunctional habits (e.g., bruxism).
- Uncontrolled systemic diseases affecting bone metabolism or healing.
- Peri-implantitis or compromised implant stability.
- Requirement for cantilever prostheses or long-span restorations, or FPDs in areas other than the mandibular anterior region.
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, 1 recruiting
- Recruiting
Mohammed Elsawy
Shibīn al Kawm, 2266166
Mohammed Elsawy, PhD, 00201061314522, mohamed.elsawy@dent.menofia.edu.eg
About this study
Official title: Clinical Performance of 3D-Printed Resin Versus Milled Monolithic Zirconia in Implant-Supported Single Crowns and Short-Span Fixed Partial Dentures: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial evaluates the clinical performance of 3D-printed resin restorations compared with milled monolithic zirconia in implant-supported single crowns and short-span fixed partial dentures (FPDs). A total of patients requiring one or two implant-supported restorations in the mandibular anterior region were randomly allocated to receive either 3D-printed permanent resin restorations (CROWNTEC) or conventionally milled zirconia prostheses.
All restorations were fabricated using a standardized digital workflow and assessed over a 12-month follow-up period. The primary outcome was restoration survival rate, while secondary outcomes included technical complications, peri-implant biological parameters, marginal bone level changes, and patient-reported satisfaction.
This study aims to provide clinical evidence regarding the viability of 3D-printed definitive resin materials as an alternative to zirconia in implant prosthodontics.
Read the detailed description
This study was designed as a parallel-arm randomized controlled clinical trial to compare the clinical performance of implant-supported restorations fabricated using a novel 3D-printed resin material (CROWNTEC) with that of conventionally milled monolithic zirconia. The investigation focused on single crowns and short-span fixed partial dentures (FPDs) in the mandibular anterior region, where functional and esthetic demands are critical.
Participants meeting predefined inclusion criteria were randomly assigned into two intervention groups: a 3D-printed resin group and a zirconia group. All restorations were produced using a fully digital workflow, including intraoral scanning, CAD design, and standardized manufacturing protocols. Prostheses were delivered as either screw-retained or cement-retained restorations, with careful control of occlusion and prosthetic design parameters.
Patients were followed at baseline, 3, 6, and 12 months, with extended follow-up planned up to 24 months. The primary outcome measure was restoration survival, defined as the absence of failure requiring replacement. Secondary outcomes included technical complications such as fracture, chipping, and screw loosening; biological parameters including plaque index, bleeding on probing, and probing depth; and radiographic assessment of marginal bone level changes. Patient-reported outcomes were also evaluated using a visual analog scale to assess satisfaction with esthetics, comfort, and masticatory function.
By directly comparing a novel additive manufacturing material with an established reference standard, this study addresses a critical gap in the literature regarding the clinical applicability of 3D-printed definitive restorations in implant dentistry. The findings are expected to contribute valuable evidence on the performance, limitations, and potential role of 3D-printed resin materials in modern prosthodontic practice.
- Conditions
- Prosthesis User
- Being tested
- 3D-Printed Resin Restoration (CROWNTEC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Printed Resin Restoration (CROWNTEC)Device
Also called Milled Zirconia Restorations
Implant-supported single crowns or short-span fixed partial dentures fabricated using 3D-printed permanent resin (CROWNTEC). Restorations are produced using a standardized digital workflow, including intraoral scanning, CAD design, 3D printing at 50 µm layer thickness, post-processing (isopropyl alcohol cleaning, post-curing), finishing, and polishing. Restorations are delivered as screw- or cement-retained prostheses. In addition, Other participants will receive implant-supported single crowns or short-span fixed partial dentures fabricated from monolithic zirconia using CAD-CAM milling. Restorations undergo sintering, finishing, and polishing, and are delive
| Study group | Role | What they receive |
|---|---|---|
| 3D-Printed Resin Restoration | Experimental | Participants will receive implant-supported single crowns or short-span fixed partial dentures fabricated using 3D-printed permanent resin (CROWNTEC). Restorations are produced via a fully digital workflow, including intraoral scanning, CAD design, 3D printing, post-processing, and finishing, and delivered as screw- or cement-retained prostheses. Receives: Device: 3D-Printed Resin Restoration (CROWNTEC) |
| Milled Zirconia Restorations | Active comparator | Participants will receive implant-supported single crowns or short-span fixed partial dentures fabricated from monolithic zirconia using CAD-CAM milling. Restorations undergo sintering, finishing, and polishing, and are delivered as screw- or cement-retained prostheses. Receives: Device: 3D-Printed Resin Restoration (CROWNTEC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration Survival Rate
The proportion of implant-supported single crowns and short-span fixed partial dentures that remain functional without fracture, loss, or need for replacement over the follow-up period. Survival is defined as the restoration remaining in situ, fully functional, and free of catastrophic failure requiring intervention.
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 posted13 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis UserStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Model description
- Parallel-group randomized clinical trial comparing 3D-printed resin and zirconia implant-supported restorations, with participants assigned to one intervention and followed over time.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522671
- Sponsor's protocol ID
- ADMNF-00326
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of 3D-Printed Resin Versus Milled Monolithic Zirconia in Implant-Supported Single Crowns and Short-Span Fixed Partial Dentures: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07522671
- Acronym / sponsor ID
- ADMNF-00326
- Conditions
- Prosthesis User
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 13 Apr 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.
This randomized controlled clinical trial evaluates the clinical performance of 3D-printed resin restorations compared with milled monolithic zirconia in implant-supported single crowns and short-span fixed partial dentures (FPDs). A total of patients requiring one or two implant-supported restorations in the mandibular anterior region were randomly allocated to receive either 3D-printed permanent resin restorations (CROWNTEC) or conventionally milled zirconia prostheses.
All restorations were fabricated using a standardized digital workflow and assessed over a 12-month follow-up period. The primary outcome was restoration survival rate, while secondary outcomes included technical complications, peri-implant biological parameters, marginal bone level changes, and patient-reported satisfaction.
This study aims to provide clinical evidence regarding the viability of 3D-printed definitive resin materials as an alternative to zirconia in implant prosthodontics.
Detailed description
This study was designed as a parallel-arm randomized controlled clinical trial to compare the clinical performance of implant-supported restorations fabricated using a novel 3D-printed resin material (CROWNTEC) with that of conventionally milled monolithic zirconia. The investigation focused on single crowns and short-span fixed partial dentures (FPDs) in the mandibular anterior region, where functional and esthetic demands are critical.
Participants meeting predefined inclusion criteria were randomly assigned into two intervention groups: a 3D-printed resin group and a zirconia group. All restorations were produced using a fully digital workflow, including intraoral scanning, CAD design, and standardized manufacturing protocols. Prostheses were delivered as either screw-retained or cement-retained restorations, with careful control of occlusion and prosthetic design parameters.
Patients were followed at baseline, 3, 6, and 12 months, with extended follow-up planned up to 24 months. The primary outcome measure was restoration survival, defined as the absence of failure requiring replacement. Secondary outcomes included technical complications such as fracture, chipping, and screw loosening; biological parameters including plaque index, bleeding on probing, and probing depth; and radiographic assessment of marginal bone level changes. Patient-reported outcomes were also evaluated using a visual analog scale to assess satisfaction with esthetics, comfort, and masticatory function.
By directly comparing a novel additive manufacturing material with an established reference standard, this study addresses a critical gap in the literature regarding the clinical applicability of 3D-printed definitive restorations in implant dentistry. The findings are expected to contribute valuable evidence on the performance, limitations, and potential role of 3D-printed resin materials in modern prosthodontic practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group randomized clinical trial comparing 3D-printed resin and zirconia implant-supported restorations, with participants assigned to one intervention and followed over time.
| Arm | Type | Receives |
|---|---|---|
| 3D-Printed Resin Restoration | Experimental | Device: 3D-Printed Resin Restoration (CROWNTEC)Participants will receive implant-supported single crowns or short-span fixed partial dentures fabricated using 3D-printed permanent resin (CROWNTEC). Restorations are produced via a fully digital workflow, including intraoral scanning, CAD design, 3D printing, post-processing, and finishing, and delivered as screw- or cement-retained prostheses. |
| Milled Zirconia Restorations | Active comparator | Device: 3D-Printed Resin Restoration (CROWNTEC)Participants will receive implant-supported single crowns or short-span fixed partial dentures fabricated from monolithic zirconia using CAD-CAM milling. Restorations undergo sintering, finishing, and polishing, and are delivered as screw- or cement-retained prostheses. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants must meet all of the following:
- Age ≥18 years.
- Have one or two osseointegrated dental implants requiring prosthetic restoration.
- Demonstrate stable peri-implant tissues with no signs of inflammation or implant mobility.
- Maintain good oral hygiene and controlled periodontal status.
Key exclusion criteria (5 listed)
- Participants are excluded if they have any of the following:
- Severe parafunctional habits (e.g., bruxism).
- Uncontrolled systemic diseases affecting bone metabolism or healing.
- Peri-implantitis or compromised implant stability.
- Requirement for cantilever prostheses or long-span restorations, or FPDs in areas other than the mandibular anterior region.
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 Resin Restoration (CROWNTEC)Also: Milled Zirconia RestorationsImplant-supported single crowns or short-span fixed partial dentures fabricated using 3D-printed permanent resin (CROWNTEC). Restorations are produced using a standardized digital workflow, including intraoral scanning, CAD design, 3D printing at 50 µm layer thickness, post-processing (isopropyl alcohol cleaning, post-curing), finishing, and polishing. Restorations are delivered as screw- or cement-retained prostheses. In addition, Other participants will receive implant-supported single crowns or short-span fixed partial dentures fabricated from monolithic zirconia using CAD-CAM milling. Restorations undergo sintering, finishing, and polishing, and are delive | Device | 3D-Printed Resin Restoration, Milled Zirconia Restorations |
Primary outcome
Restoration Survival Rate
Time frame: 12 months
The proportion of implant-supported single crowns and short-span fixed partial dentures that remain functional without fracture, loss, or need for replacement over the follow-up period. Survival is defined as the restoration remaining in situ, fully functional, and free of catastrophic failure requiring intervention.
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 13 Apr 2026.
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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.
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 Resin Restoration (CROWNTEC) in people with Prosthesis User, run by Menoufia 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 8 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: looking for participants now, as of the sponsor's last update on 13 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?
Contact Mohammed A. Elsawy, PhD (00201061314522, mohamed.elsawy@dent.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration Survival Rate (time frame: 12 months). 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 13 Apr 2026.