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RecruitingNCT06713330Updated Jun 29, 2026

Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth

An interventional study of BioFLX crown and 3M Stainless Steel Crown in Dental Caries, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled May 2024, registered Nov 2024).
  • Started May 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
2 Years to 5 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Dental Caries

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Keywords

  • Pediatric dentistry
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
    • 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

    1. Extensive caries
    2. Cervical decalcification
    3. Developmental defects (e.g., hypoplasia, hypocalcification)
    4. When failure of other available restorative materials is likely (e.g., interproximal caries extending beyond line angles, patients with bruxism)
    5. Following pulpotomy or pulpectomy
    6. For definitive restorative treatment for high caries-risk children as defined by the AAPD
    7. 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    SSC

    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.

    Device: 3M Stainless Steel Crown

  • Experimental
    BioFLX Crown

    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.

    Device: BioFLX crown

Interventions

  • DeviceBioFLX crown

    Device: BioFLX crown

  • Device3M Stainless Steel Crown

    3M Stainless Steel Crown

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — It can be if needed

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06713330
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Responsible party
Patrick Ruck (Primary investigator, Children's Hospital Medical Center, Cincinnati) — Principal investigator
First posted
Dec 3, 2024
Start date
May 17, 2024
Primary completion
Dec 29, 2027 (estimated)
Completion
Dec 29, 2027 (estimated)
Last update
Jun 29, 2026

Study contacts

Patrick Ruck, DDS
Contact
Patrick.ruck@cchmc.org
7575602623

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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