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

Children's Hospital Medical Center, Cincinnati · NCT06713330

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–5 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
1
Study start
May 17, 2024
Record last updated
June 29, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: BioFLX crown; 3M Stainless Steel Crown

Conditions: Dental Caries

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

  • 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

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.

Recruiting US locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, OH 45229

    Site contact: Patrick T Ruck · 757-560-2623 · patrick.ruck@cchmc.org

Study contacts (from the official record)

  • Patrick Ruck, DDS · 7575602623 · Patrick.ruck@cchmc.org
Comparing Stainless Steel Crowns With Prefabricated Resin Crowns… (NCT06713330) | Bored Studies