Dental Caries3DRSCVSSSCNCT07648979
3D-Printed Resin Crowns vs Stainless Steel Crowns in Pulpotomized Primary Molars.
A study testing 3D printed resin based crowns and Prefabricated stainless steel crowns in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn whether 3D-printed resin-based crowns are an effective alternative to stainless steel crowns for restoring pulpotomized primary mandibular molars in children. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- 3D printed resin based crowns and Prefabricated stainless steel crowns
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2026to 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 8 years. Cooperative children who are able to accept dental treatment. Teeth diagnosed with reversible pulpitis. Children in good general health with no systemic conditions affecting oral health.
- Parents/guardians willing to provide written informed consent and attend follow-up visits.
Who cannot join
- Teeth deemed non-restorable (e.g., gross carious destruction or fractures beyond restoration).
- Parents/guardians unwilling to participate in the study or provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of 3D Printed Resin Based Crowns Versus Stainless Steel Crowns in Pulpotomized Primary Mandibular Molars : A Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn whether 3D-printed resin-based crowns are an effective alternative to stainless steel crowns for restoring pulpotomized primary mandibular molars in children. The main questions it aims to answer are:
Do 3D-printed resin-based crowns provide better gingival health than stainless steel crowns? Are there differences in plaque accumulation, crown retention, and child and parent satisfaction between the two crown types?
Participants will:
Receive either a 3D-printed resin-based crown or a stainless steel crown after pulpotomy.
Attend follow-up visits for clinical evaluation over 12 months.
Read the detailed description
primary mandibular molars will be randomly assigned to receive either 3D-printed resin-based crowns or stainless steel crowns. Following pulp therapy and crown placement, participants will attend follow-up visits over a 12-month period. Clinical evaluation will be performed to assess gingival health, plaque accumulation, crown retention, and child and parent satisfaction, in order to determine whether 3D-printed resin-based crowns can be an effective esthetic alternative to stainless steel crowns.
- Conditions
- Dental Caries
- Being tested
- 3D printed resin based crowns, Prefabricated stainless steel crowns
- Keywords
- Dental caries, 3D-Printed Resin Crowns, Primary Molars, Pulpotomy, Stainless Steel Crowns, crown retention, Gingival Health
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed resin based crownsDevice
1-Select an appropriately sized resin-based prefabricated crown based on the mesio-distal width of the tooth. 2-Perform occlusal reduction of approximately 1.5-2.0 mm following the natural occlusal anatomy. 3-Reduce buccal and lingual cusps, central groove, and marginal ridges to achieve adequate occlusal clearance. 4-Perform proximal reduction using a tapered fissure or diamond bur to eliminate mesial and distal contacts by approximately 1.0 mm. 5-Avoid creating ledges or damaging adjacent teeth during proximal reduction. 6-Slightly reduce buccal and lingual surfaces to eliminate undercuts and facilitate crown seating. 7-Round and smooth all sharp line angles and points of the preparation. 8-In cases with adjacent teeth, perform additional interproximal reduction if required for proper seating.9-Try-in the crown intraorally and seat it using firm pressure from lingual to buccal direction. 10-Check marginal adaptation, ensuring slight subgingival extension (approximately 0.5-1.0 mm).
Prefabricated stainless steel crownsDevice
1-Select an appropriately sized stainless steel crown based on the mesiodistal width of the tooth. 2-Perform minimal occlusal reduction (approximately 1.0-1.5 mm) following the anatomical occlusal contour to create suficient space for crown placement. 3-Lightly reduce proximal contacts to allow crown seating, without creating steps or excessive taper. 4-Perform minimal buccal and lingual reduction only if required to eliminate undercuts and facilitate passive seating. 5-Round sharp line angles and smooth rough surfaces to allow proper adaptation. 5-Verify adequate occlusal clearance and passive path of insertion. 6-Try-in the crown and adjustsize if necessary to ensure proper fit. 7-Trim and contour crown margins to achieve optimal gingival adaptation (if needed). 8-Seat the crown firmly using finger pressure to confirm complete seating. 9-Cement the crown with glass ionomer cement and remove excess cement after initial setting.
| Study group | Role | What they receive |
|---|---|---|
| 3D printed resin crowns | Experimental | Children will receive indirect restorations using 3D-printed resin crowns on primary molars affected by reversible pulpitis Receives: Device: 3D printed resin based crowns |
| Stainless steel crowns | Active comparator | Children will receive stainless steel crowns on primary molars affected by reversible pulpitis Receives: Device: Prefabricated stainless steel crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival index
The GI was measured by passing an explorer tip gently within the sulcus mesial, distal, buccal, and lingual surface of each crowned molar. it was scored on a scale of 0 to 3 0= no bleeding
- only one bleeding point appearing someseconds after probing
- bleeding points appearing immediately after probing
- profuse bleeding appearing immediately after probing spreading towards the marginal gingiva
Measured: baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcomes (3)
Plaque accumulation
Silness \&Löe plaque index 0: no plaque. 1: film at gingival margin. 2: moderate accumulation. 3: abundance of plaque.
Measured: baseline, 3 months, 6 months, 9 months, 12 months
Child and parent satisfaction
Child and parent satisfaction will be assessed using a structured questionnaire based on a Likert scale. Participants (children and their parents/guardians) will rate their satisfaction with the treatment experience, comfort, aesthetics, and overall acceptance. Responses will be recorded on a 5-point Likert scale ranging from "very dissatisfied" to "very satisfied." The scores will be analyzed to compare satisfaction between study groups.
Measured: Immediately post operative
Crown retention
Using United States Public Health Service (USPHS) criteria Alpha : intact Bravo : chipped or loss of material Charlie : complete loss of crown
Measured: baseline, 3 months, 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Participants will be randomly assigned to one of two parallel groups. One group will receive 3D-printed resin-based crowns, while the other group will receive stainless steel crowns following pulpotomy of primary mandibular molars.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nariman osama Mohamed, Cairo University
- Investigators
- Sherine Badr, PHD, Study chair, Cairo UniversityNariman Osama, BDS, Principal investigator, Cairo UniversityHanna Abdel Moneim, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648979
- Sponsor's protocol ID
- FDCU-2026-01
- Acronym
- 3DRSCVSSSC
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared. The study is conducted as part of a master's degree project, and participant confidentiality and privacy will be maintained according to institutional ethical guidelines. Only aggregated and anonymized study results may be published or presented
Publications
Flores F, Silva A, Willig R, Reyes A, Serpa J, Marconcin P, Vieira F, Soares D, Casanova N. Exergames as an Effective Alternative to Real Environmental Tennis Training for Adolescents. Sports (Basel). 2024 Jun 17;12(6):168. doi: 10.3390/sports12060168.
PubMed 38921862
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 3D Printed Resin Based Crowns Versus Stainless Steel Crowns in Pulpotomized Primary Mandibular Molars : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07648979
- Acronym / sponsor ID
- 3DRSCVSSSC / FDCU-2026-01
- Conditions
- Dental Caries
- Keywords
- Dental caries, 3D-Printed Resin Crowns, Primary Molars, Pulpotomy, Stainless Steel Crowns, crown retention, Gingival Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Jun 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 goal of this clinical trial is to learn whether 3D-printed resin-based crowns are an effective alternative to stainless steel crowns for restoring pulpotomized primary mandibular molars in children. The main questions it aims to answer are:
Do 3D-printed resin-based crowns provide better gingival health than stainless steel crowns? Are there differences in plaque accumulation, crown retention, and child and parent satisfaction between the two crown types?
Participants will:
Receive either a 3D-printed resin-based crown or a stainless steel crown after pulpotomy.
Attend follow-up visits for clinical evaluation over 12 months.
Detailed description
primary mandibular molars will be randomly assigned to receive either 3D-printed resin-based crowns or stainless steel crowns. Following pulp therapy and crown placement, participants will attend follow-up visits over a 12-month period. Clinical evaluation will be performed to assess gingival health, plaque accumulation, crown retention, and child and parent satisfaction, in order to determine whether 3D-printed resin-based crowns can be an effective esthetic alternative to stainless steel crowns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. One group will receive 3D-printed resin-based crowns, while the other group will receive stainless steel crowns following pulpotomy of primary mandibular molars.
| Arm | Type | Receives |
|---|---|---|
| 3D printed resin crowns | Experimental | Device: 3D printed resin based crownsChildren will receive indirect restorations using 3D-printed resin crowns on primary molars affected by reversible pulpitis |
| Stainless steel crowns | Active comparator | Device: Prefabricated stainless steel crownsChildren will receive stainless steel crowns on primary molars affected by reversible pulpitis |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 4 to 8 years. Cooperative children who are able to accept dental treatment. Teeth diagnosed with reversible pulpitis. Children in good general health with no systemic conditions affecting oral health.
- Parents/guardians willing to provide written informed consent and attend follow-up visits.
Key exclusion criteria (2 listed)
- Teeth deemed non-restorable (e.g., gross carious destruction or fractures beyond restoration).
- Parents/guardians unwilling to participate in the study or provide informed consent.
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 based crowns1-Select an appropriately sized resin-based prefabricated crown based on the mesio-distal width of the tooth. 2-Perform occlusal reduction of approximately 1.5-2.0 mm following the natural occlusal anatomy. 3-Reduce buccal and lingual cusps, central groove, and marginal ridges to achieve adequate occlusal clearance. 4-Perform proximal reduction using a tapered fissure or diamond bur to eliminate mesial and distal contacts by approximately 1.0 mm. 5-Avoid creating ledges or damaging adjacent teeth during proximal reduction. 6-Slightly reduce buccal and lingual surfaces to eliminate undercuts and facilitate crown seating. 7-Round and smooth all sharp line angles and points of the preparation. 8-In cases with adjacent teeth, perform additional interproximal reduction if required for proper seating.9-Try-in the crown intraorally and seat it using firm pressure from lingual to buccal direction. 10-Check marginal adaptation, ensuring slight subgingival extension (approximately 0.5-1.0 mm). | Device | 3D printed resin crowns |
| Prefabricated stainless steel crowns1-Select an appropriately sized stainless steel crown based on the mesiodistal width of the tooth. 2-Perform minimal occlusal reduction (approximately 1.0-1.5 mm) following the anatomical occlusal contour to create suficient space for crown placement. 3-Lightly reduce proximal contacts to allow crown seating, without creating steps or excessive taper. 4-Perform minimal buccal and lingual reduction only if required to eliminate undercuts and facilitate passive seating. 5-Round sharp line angles and smooth rough surfaces to allow proper adaptation. 5-Verify adequate occlusal clearance and passive path of insertion. 6-Try-in the crown and adjustsize if necessary to ensure proper fit. 7-Trim and contour crown margins to achieve optimal gingival adaptation (if needed). 8-Seat the crown firmly using finger pressure to confirm complete seating. 9-Cement the crown with glass ionomer cement and remove excess cement after initial setting. | Device | Stainless steel crowns |
Primary outcome
Gingival index
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
The GI was measured by passing an explorer tip gently within the sulcus mesial, distal, buccal, and lingual surface of each crowned molar. it was scored on a scale of 0 to 3 0= no bleeding 1. only one bleeding point appearing someseconds after probing 2. bleeding points appearing immediately after probing 3. profuse bleeding appearing immediately after probing spreading towards the marginal gingiva
3 secondary outcomes
Plaque accumulation
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
Child and parent satisfaction
Time frame: Immediately post operative
Crown retention
Time frame: baseline, 3 months, 6 months, 9 months, 12 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 15 Jun 2026.
- Background: PubMed 38921862Flores F, Silva A, Willig R, Reyes A, Serpa J, Marconcin P, Vieira F, Soares D, Casanova N. Exergames as an Effective Alternative to Real Environmental Tennis Training for Adolescents. Sports (Basel). 2024 Jun 17;12(6):168. doi: 10.3390/sports12060168.
- Official ClinicalTrials.gov website providing information about clinical trial registration and study records.Link provided by the sponsor.
- regarding 3D-printed resin-based dental restorative materials used in this studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared. The study is conducted as part of a master's degree project, and participant confidentiality and privacy will be maintained according to institutional ethical guidelines. Only aggregated and anonymized study results may be published or presented
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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.
Sherine Badr, PHD study chair
Cairo University
Nariman Osama, BDS principal investigator
Cairo University
Hanna Abdel Moneim, PHD study director
Cairo University
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 based crowns and Prefabricated stainless steel crowns in people with Dental Caries, run by Cairo 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 2 inclusion and 2 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 15 Jun 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 Nariman Osama, BDS (01010381531, Nareman.osama@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival index (time frame: baseline, 3 months, 6 months, 9 months, 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 NCT07648979, which also lists 1 linked publication.
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 15 Jun 2026.