Caries, DentalNCT07091331
3D-printed Ceromer Crowns Versus Stainless Steel in Posterior Primary Molars
A study testing Personalized 3D-printed pediatric ceromer crown and Prefabricated stainless steel crown group in people with Caries, Dental and Caries; Dentin, run by Universidad Autonoma de Baja California at 1 site in Mexico.
Trial summary
The aim of the study is to compare preformed metal crowns and 3D-printed ceromer crowns in primary molars of 4-9 years old children. The main questions it aims to answer are: How does 3D-printed ceromer crowns compare clincally to stainless steel crowns when restoring posterior molars? What is the level of… Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Caries, Dental, Caries; Dentin, Dental Caries in Children
- What is being tested?
- Personalized 3D-printed pediatric ceromer crown and Prefabricated stainless steel crown group
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 30 Jul 2025to 15 Jun 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 9 years with at least 2 primary molars affected by deep occlusoproximal caries.
- Teeth may require pulp therapy (pulpotomy or pulpectomy) and be suitable for full-coverage restoration.
- Teeth must have an antagonist and be located in opposing hemiarches.
- The affected primary molars must be expected to remain in the mouth for at least 12 months.
- The child must be in general good health.
- Parents or legal guardians must sign informed consent, and the child must provide assent.
- Patient does not come to control appointment or does not want to continue research.
Who cannot join
- Children with systemic diseases or medical conditions affecting oral health.
- Uncooperative behavior (Frankl scale 3 or 4).
- Temporomandibular joint disorders or parafunctional habits (e.g., bruxism).
- Absence of antagonist or adjacent teeth in the selected quadrants.
- Children on long-term medication.
- Patient with allergy to local anesthetic, nickel or chromium.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Facultad de Odontología
Tijuana, Estado de Baja California, 22427
Patricia Preciado, DDS, MPH
Alan Velazquez, DDS, MPH
About this study
Official title: Clinical Evaluation of 3D-printed Ceromer Crowns Versus Stainless Steel in Posterior Primary Molars
The aim of the study is to compare preformed metal crowns and 3D-printed ceromer crowns in primary molars of 4-9 years old children. The main questions it aims to answer are:
- How does 3D-printed ceromer crowns compare clincally to stainless steel crowns when restoring posterior molars?
- What is the level of satisfaction of the patient with both materials?
- What is the level of parental satisfaction with both materials?
Study methodology:
This study is a split-mouth clinical trial where participants will receive at least one of each materials in different quadrants of the mouth.
Read the detailed description
This randomized clinical trial is designed following the Consolidated Standards of Reporting Trials (CONSORT) guidelines and will adopt a prospective, split-mouth approach. The objective is to compare the clinical performance of crowns fabricated with three-dimensional (3D) printed ceromer material against conventional preformed stainless steel crowns in extensively decayed primary posterior teeth. The unit of observation will be gingival inflammation in the area surrounding the restorations, evaluated at specific time points over a 12-month follow-up period (3, 6 and 12 months).
Each eligible participant will receive both types of crowns, with assignments made to contralateral quadrants of the mouth to allow for within-subject comparison. This methodology minimizes inter-individual variability and strengthens internal validity. The ceromer crowns will be fabricated via additive manufacturing (3D printing), while the stainless steel crowns will follow the conventional selection and crimping technique.
Written informed consent will be obtained from their guardians or parents. An expected total of 50 primary molars of healthy participants will be restored.
- Conditions
- Caries, Dental, Caries; Dentin, Dental Caries in Children
- Being tested
- Personalized 3D-printed pediatric ceromer crown, Prefabricated stainless steel crown group
- Keywords
- Printing, Three-dimensional, Pediatric Dentistry, Tooth, Deciduous, Esthetics, Dental
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized 3D-printed pediatric ceromer crownProcedure or surgery
After primary molar crown preparation, digital impression using intraoral scanner (i700, Medit, Seoul, South Korea), crown will be designed with CAD software (CliniCAD, medit, South Korea) and fabricated using a 3D printer, (Sonic mini 4k, Phrozen, Taipei, Taiwan). Crown will be cemented by passive seating using a self-adhesive dual cure cement (Beauticem, shofu, San Marcos, CA, USA)
Prefabricated stainless steel crown groupDevice
Stainless steel crown application: After preparation of the tooth, the crown will be filled and cemented with type-1 glass ionomer cement (Ketac Cem easymix, 3M ESPE, Minnesota, USA)
| Study group | Role | What they receive |
|---|---|---|
| 3D-printed ceromer crown | Experimental | Group A: 3D-printed ceromer crown (Sculpture, Rodin Resins, La Brea, CA, USA) Receives: Procedure: Personalized 3D-printed pediatric ceromer crown |
| Stainless steel crown | Active comparator | Group B: Stainless steel crown (3M Espe, Saint Paul, MN, USA) Receives: Device: Prefabricated stainless steel crown group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index (PI) (Silness and Loe, 1964)
0- No plaque in the area adjacent to the gingiva
- There is a thin film on the edge of the gingival margin. (detected with the help of a probe)
- There is presence of plaque in the gingival pocket and gingival margin at a level that can be determined by eye. There is no plaque in the proximal area.
- A large amount of plaque layer is observed in the gingival pocket and gingival margin. Interdental area is filled with plaque.
Measured: 12 months
Gingival Index (GI) (Loe & Silness, 1963)
0- Healthy gingiva, no inflammation
- Mild inflammation, discoloration and mild edema of the gums, no bleeding on probing.
- Moderate inflammation, redness and edema in gums, bleeding on probing.
- Advanced inflammation, redness, edema in gums, spontaneous bleeding is observed.
Measured: 12 months
International Dental Federation (FDI) criteria used for clinical evaluation of indirect restorations
Functional, Biological and Esthetic properties, scored from 1-5 (higher score meaning worse result.
Measured: 12 months
Secondary outcomes (2)
Patient satisfaction
A 5 question satisfaction questionnaire with 5 point lykert scale questions
Measured: 6 months
Parental satisfaction
A 5 question satisfaction questionnaire with 5 point lykert scale questions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion15 Jun 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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Velazquez, Universidad Autonoma de Baja California
- Investigators
- Alan Velazquez, DDS, MPH, Principal investigator, Universidad Autonoma de Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091331
- Sponsor's protocol ID
- 2735
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD will be shared to with
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 3D-printed Ceromer Crowns Versus Stainless Steel in Posterior Primary Molars
- ClinicalTrials.gov ID
- NCT07091331
- Acronym / sponsor ID
- 2735
- Conditions
- Caries, Dental, Caries; Dentin, Dental Caries in Children
- Keywords
- Printing, Three-dimensional, Pediatric Dentistry, Tooth, Deciduous, Esthetics, Dental
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 29 Jul 2025 (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 the study is to compare preformed metal crowns and 3D-printed ceromer crowns in primary molars of 4-9 years old children. The main questions it aims to answer are:
- How does 3D-printed ceromer crowns compare clincally to stainless steel crowns when restoring posterior molars?
- What is the level of satisfaction of the patient with both materials?
- What is the level of parental satisfaction with both materials?
Study methodology:
This study is a split-mouth clinical trial where participants will receive at least one of each materials in different quadrants of the mouth.
Detailed description
This randomized clinical trial is designed following the Consolidated Standards of Reporting Trials (CONSORT) guidelines and will adopt a prospective, split-mouth approach. The objective is to compare the clinical performance of crowns fabricated with three-dimensional (3D) printed ceromer material against conventional preformed stainless steel crowns in extensively decayed primary posterior teeth. The unit of observation will be gingival inflammation in the area surrounding the restorations, evaluated at specific time points over a 12-month follow-up period (3, 6 and 12 months).
Each eligible participant will receive both types of crowns, with assignments made to contralateral quadrants of the mouth to allow for within-subject comparison. This methodology minimizes inter-individual variability and strengthens internal validity. The ceromer crowns will be fabricated via additive manufacturing (3D printing), while the stainless steel crowns will follow the conventional selection and crimping technique.
Written informed consent will be obtained from their guardians or parents. An expected total of 50 primary molars of healthy participants will be restored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-printed ceromer crown | Experimental | Procedure: Personalized 3D-printed pediatric ceromer crownGroup A: 3D-printed ceromer crown (Sculpture, Rodin Resins, La Brea, CA, USA) |
| Stainless steel crown | Active comparator | Device: Prefabricated stainless steel crown groupGroup B: Stainless steel crown (3M Espe, Saint Paul, MN, USA) |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 4 to 9 years with at least 2 primary molars affected by deep occlusoproximal caries.
- Teeth may require pulp therapy (pulpotomy or pulpectomy) and be suitable for full-coverage restoration.
- Teeth must have an antagonist and be located in opposing hemiarches.
- The affected primary molars must be expected to remain in the mouth for at least 12 months.
- The child must be in general good health.
Key exclusion criteria (6 listed)
- Children with systemic diseases or medical conditions affecting oral health.
- Uncooperative behavior (Frankl scale 3 or 4).
- Temporomandibular joint disorders or parafunctional habits (e.g., bruxism).
- Absence of antagonist or adjacent teeth in the selected quadrants.
- Children on long-term medication.
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 |
|---|---|---|
| Personalized 3D-printed pediatric ceromer crownAfter primary molar crown preparation, digital impression using intraoral scanner (i700, Medit, Seoul, South Korea), crown will be designed with CAD software (CliniCAD, medit, South Korea) and fabricated using a 3D printer, (Sonic mini 4k, Phrozen, Taipei, Taiwan). Crown will be cemented by passive seating using a self-adhesive dual cure cement (Beauticem, shofu, San Marcos, CA, USA) | Procedure or surgery | 3D-printed ceromer crown |
| Prefabricated stainless steel crown groupStainless steel crown application: After preparation of the tooth, the crown will be filled and cemented with type-1 glass ionomer cement (Ketac Cem easymix, 3M ESPE, Minnesota, USA) | Device | Stainless steel crown |
Primary outcome
Plaque index (PI) (Silness and Loe, 1964)
Time frame: 12 months
0- No plaque in the area adjacent to the gingiva 1. There is a thin film on the edge of the gingival margin. (detected with the help of a probe) 2. There is presence of plaque in the gingival pocket and gingival margin at a level that can be determined by eye. There is no plaque in the proximal area. 3. A large amount of plaque layer is observed in the gingival pocket and gingival margin. Interdental area is filled with plaque.
Gingival Index (GI) (Loe & Silness, 1963)
Time frame: 12 months
0- Healthy gingiva, no inflammation 1. Mild inflammation, discoloration and mild edema of the gums, no bleeding on probing. 2. Moderate inflammation, redness and edema in gums, bleeding on probing. 3. Advanced inflammation, redness, edema in gums, spontaneous bleeding is observed.
International Dental Federation (FDI) criteria used for clinical evaluation of indirect restorations
Time frame: 12 months
Functional, Biological and Esthetic properties, scored from 1-5 (higher score meaning worse result.
2 secondary outcomes
Patient satisfaction
Time frame: 6 months
Parental satisfaction
Time frame: 6 months
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 29 Jul 2025.
- Individual participant dataSharing planned: Yes. IPD will be shared to with
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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.
Alan Velazquez, DDS, MPH principal investigator
Universidad Autonoma de Baja California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized 3D-printed pediatric ceromer crown and Prefabricated stainless steel crown group in people with Caries, Dental and Caries; Dentin, run by Universidad Autonoma de Baja California at 1 site in Mexico.
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 7 inclusion and 6 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 29 Jul 2025. 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 Mexico. 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 Alan Velazquez, DDS, MPH (+526644622237, avelazquez81@uabc.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (PI) (Silness and Loe, 1964) (time frame: 12 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?
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 29 Jul 2025.