Comparing white dental crowns to metal crowns for children's teeth

A 36-Month Prospective Randomized Clinical Pilot Trial Comparing Stainless Steel Crowns with Prefabricated Resin Crowns in Primary Molar Teeth

This study tests if a new flexible white dental crown works just as well as the traditional metal crown for young children needing dental work.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 2 Years to 5 Years
• Sex: All
• Sponsor: Children's Hospital Medical Center, Cincinnati (Academic / other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT06713330 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a new flexible white dental crown, known as BioFLX, in comparison to the traditional stainless steel crown used in pediatric dentistry. The research focuses on children aged 2 to 5 years who require full mouth dental rehabilitation due to cavities. Participants will be randomly assigned to receive either the BioFLX crown or the stainless steel crown, with treatment conducted under general anesthesia to ensure a controlled environment. The goal is to determine if the new crown is clinically equivalent to the existing option.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 2 to 5 years who require full coverage dental restorations due to cavities.

Not a fit: Patients who do not require crowns or are outside the specified age range will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more aesthetically pleasing and flexible crown option for children, improving their dental experience.

How similar studies have performed: While similar studies have explored crown options in pediatric dentistry, the specific comparison of BioFLX to stainless steel crowns is a novel approach.

Eligibility 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
  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.

Where this trial is running

Cincinnati, Ohio

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Patrick Ruck, DDS

Conditions Dental Caries; Pediatric dentistry