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Comparing BioFLX and 3M Stainless Steel Crowns for Children

This study is comparing two types of dental crowns for young children with cavities: a new white crown called BioFLX and an existing silver crown called 3M Stainless Steel Crown. The main goal is to see if the BioFLX crown works just as well as the 3M Stainless Steel Crown. Children between 2 and 5 years old who need dental work under general anesthesia for cavities requiring crowns may be able to join. Researchers will look at how well the crowns perform over 36 months using specific dental criteria. The study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This interventional study plans to enroll 50 participants. It is comparing two different dental devices.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 36 months to assess the crowns' performance.

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NCT06713330

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

Recruiting
NAAges 2–5InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~50 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:BioFLX crown3M Stainless Steel Crown

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The United States Public Health Service Restorative criteria
Measured over 36 months

Conditions

Dental Caries

Explore related trials

Caries

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Patrick Ruck, DDS
[email protected]
7575602623
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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
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
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.

What this trial measures

  • The United States Public Health Service Restorative criteria36 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