Dental CariesNCT06713330
Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth
A study testing BioFLX crown and 3M Stainless Steel Crown in people with Dental Caries, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The main reason for this research study is to learn more about a new flexible white dental crown (BioFLX) by comparing it to an existing flexible metal crown (Stainless Steel Crown). Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- BioFLX crown and 3M Stainless Steel Crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2024to 29 Dec 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- CCHMC pediatric dental patients between the ages of 2 years to 5 years and 11 months, at the time of recruitment, who present to any CCHMC dental clinic location and then are found to need full mouth dental rehabilitation.
- Patients who speak the most common languages at CCHMC will be able to be recruited for the study.
- o English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.
- These patients must qualify for treatment at the CCHMC dental in-office general anesthesia (IOGA) area or the Procedure Center (PC). IOGA and the PC will be selected as a venue of treatment to control behavioral factors. This is not specific to the study and would occur due to their treatment needs.
- Participants will have at least one pair of contralateral primary molars with the need for a full coverage restoration in the same arch.
- For example, tooth A \& J, B \& I, S \& L, or T \& K
Show all 18Show fewer
- For each participant, a minimum of one SSC or one PRC will be randomly assigned via a split mouth design to be placed as part of the study.
- Need for Full coverage and high caries risk will be defined by AAPD Best Practice Guidelines 2,16
- o Teeth With
- Extensive caries
- Cervical decalcification
- Developmental defects (e.g., hypoplasia, hypocalcification)
- When failure of other available restorative materials is likely (e.g., interproximal caries extending beyond line angles, patients with bruxism)
- Following pulpotomy or pulpectomy
- For definitive restorative treatment for high caries-risk children as defined by the AAPD
- For patients who exhibit high caries risk and whose treatment is performed under sedation or general anesthesia. This would be normal and not specific to the study.
- Participants who consent to the study, and who can be available for follow-up recall appointments.
- All participants will be ASA I or ASA II as defined by the American Society of Anesthesiologists.15
Who cannot join
- Participants who do not meet inclusion criteria will be excluded.
- Participants whose teeth do not meet the inclusion criteria.
- Participants who do not wish to participate in the study.
- Patients who do not wish to or cannot reliably return for follow-up visits.
- Red dye allergy as patient will not be able to be plaque disclosed during follow-up visits.
- Participants who do not speak English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Patrick T Ruck, 757-560-2623, patrick.ruck@cchmc.org
About this study
Official title: A 36-Month Prospective Randomized Clinical Pilot Trial Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth
The main reason for this research study is to learn more about a new flexible white dental crown (BioFLX) by comparing it to an existing flexible metal crown (Stainless Steel Crown). It is of interest to see if this new white crown is clinically equivalent to the existing silver crown that is mainly used in pediatric dentistry. A potential participant for this study would have cavities that require a crown, a type of filling that covers the entire tooth, and recommended dental work be done under general anesthesia.
- Conditions
- Dental Caries
- Being tested
- BioFLX crown, 3M Stainless Steel Crown
- Keywords
- Pediatric dentistry
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFLX crownDevice
Device: BioFLX crown
3M Stainless Steel CrownDevice
3M Stainless Steel Crown
| Study group | Role | What they receive |
|---|---|---|
| SSC | Other | Experimental: 3M Stainless Steel Crowns. In this split-mouth design, subjects were randomly assigned to receive SSC in the left or right side of the mouth. Receives: Device: 3M Stainless Steel Crown |
| BioFLX Crown | Experimental | Experimental: BioFLX Crowns. In this split-mouth design, subjects were randomly assigned to receive BioFLX crowns on the side opposite of the 3M Stainless Steel Crowns. Receives: Device: BioFLX crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
The United States Public Health Service Restorative criteria
Study criteria being selected would be: Gingival Health, Plaque retention, Occlusal wear, and crown retention as defined by the following Alpha, Bravo, Charlie.
Gingival Health according to the Modified Gingival Index (MGI):
Alpha (A) normal gingiva
Bravo (B) mild inflammation:
Charlie (C) moderate inflammation
Plaque Retention according to the Simplified Oral Hygiene Index (OHI -S):
Alpha (A) 0, 1 Bravo (B)2 Charlie (C) 3
Occlusal Wear:
Alpha (A) occlusal surface intact Bravo (B) wear of occlusal surface without tooth surface exposure Charlie (C) wear of occlusal surface with tooth surface exposure.
Crown retention:
Alpha (A) Intact crown Bravo (B) partial loss of crown material Charlie (C) Crown lost
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start17 May 2024
- Primary completion29 Dec 2027 (estimated)
- Study completion29 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- The purpose of this 36-month prospective, randomized controlled, split-mouth pilot study, is to compare a new prefabricated resin crown material against the gold standard stainless steel crown in primary molars that require full coverage restorations. The results of this study can help determine if resin polymer crowns clinically perform like stainless steel crowns, and if they are an acceptable esthetic alternative treatment option for a full coverage restoration of a primary molar.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Ruck, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713330
- Sponsor's protocol ID
- 2024-0022
- Status last verified
- Jun 2026
- First submitted
- 27 Nov 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: It can be if needed
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 36-Month Prospective Randomized Clinical Pilot Trial Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth
- ClinicalTrials.gov ID
- NCT06713330
- Acronym / sponsor ID
- 2024-0022
- Conditions
- Dental Caries
- Keywords
- Pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 29 Dec 2027 (estimated)
- Study completion
- 29 Dec 2027 (estimated)
- First posted
- 3 Dec 2024 (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 main reason for this research study is to learn more about a new flexible white dental crown (BioFLX) by comparing it to an existing flexible metal crown (Stainless Steel Crown). It is of interest to see if this new white crown is clinically equivalent to the existing silver crown that is mainly used in pediatric dentistry. A potential participant for this study would have cavities that require a crown, a type of filling that covers the entire tooth, and recommended dental work be done under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The purpose of this 36-month prospective, randomized controlled, split-mouth pilot study, is to compare a new prefabricated resin crown material against the gold standard stainless steel crown in primary molars that require full coverage restorations. The results of this study can help determine if resin polymer crowns clinically perform like stainless steel crowns, and if they are an acceptable esthetic alternative treatment option for a full coverage restoration of a primary molar.
| Arm | Type | Receives |
|---|---|---|
| SSC | Other | Device: 3M Stainless Steel CrownExperimental: 3M Stainless Steel Crowns. In this split-mouth design, subjects were randomly assigned to receive SSC in the left or right side of the mouth. |
| BioFLX Crown | Experimental | Device: BioFLX crownExperimental: BioFLX Crowns. In this split-mouth design, subjects were randomly assigned to receive BioFLX crowns on the side opposite of the 3M Stainless Steel Crowns. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- CCHMC pediatric dental patients between the ages of 2 years to 5 years and 11 months, at the time of recruitment, who present to any CCHMC dental clinic location and then are found to need full mouth dental rehabilitation.
- Patients who speak the most common languages at CCHMC will be able to be recruited for the study.
- o English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.
- These patients must qualify for treatment at the CCHMC dental in-office general anesthesia (IOGA) area or the Procedure Center (PC). IOGA and the PC will be selected as a venue of treatment to control behavioral factors. This is not specific to the study and would occur due to their treatment needs.
- Participants will have at least one pair of contralateral primary molars with the need for a full coverage restoration in the same arch.
Key exclusion criteria (6 listed)
- Participants who do not meet inclusion criteria will be excluded.
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 |
|---|---|---|
| BioFLX crownDevice: BioFLX crown | Device | BioFLX Crown |
| 3M Stainless Steel Crown3M Stainless Steel Crown | Device | SSC |
Primary outcome
The United States Public Health Service Restorative criteria
Time frame: 36 months
Study criteria being selected would be: Gingival Health, Plaque retention, Occlusal wear, and crown retention as defined by the following Alpha, Bravo, Charlie. Gingival Health according to the Modified Gingival Index (MGI): Alpha (A) normal gingiva Bravo (B) mild inflammation: Charlie (C) moderate inflammation Plaque Retention according to the Simplified Oral Hygiene Index (OHI -S): Alpha (A) 0, 1 Bravo (B)2 Charlie (C) 3 Occlusal Wear: Alpha (A) occlusal surface intact Bravo (B) wear of occlusal surface without tooth surface exposure Charlie (C) wear of occlusal surface with tooth surface exposure. Crown retention: Alpha (A) Intact crown Bravo (B) partial loss of crown material Charlie (C) Crown lost
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 Jun 2026.
- Individual participant dataSharing planned: No. It can be if needed
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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 BioFLX crown and 3M Stainless Steel Crown in people with Dental Caries, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 18 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: looking for participants now, as of the sponsor's last update on 29 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 United States. 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 Patrick Ruck, DDS (7575602623, Patrick.ruck@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The United States Public Health Service Restorative criteria (time frame: 36 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 29 Jun 2026.