Recruiting

Stainless Steel vs. Resin

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06713330

Conditions

Dental Caries

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Accepted

Interventions

BioFLX crown

3M Stainless Steel Crown

Study Details

Brief 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.

Conditions

Dental Caries

Study ID

NCT06713330

Start date

May 17, 2024

Status verified date

Jun, 2026

Completion date

Dec 29, 2027

Anticipated

Primary completion date

Dec 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Accepted

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:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

BioFLX crown

Device: BioFLX crown

3M Stainless Steel Crown

3M Stainless Steel Crown

Primary outcome measure

  • The United States Public Health Service Restorative criteria [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Pediatric dentistry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-06-29.