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

Last updated: December 5, 2024
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

BioFLX

3M Stainless Steel Crown

BioFLX crown

Clinical Study ID

NCT06713330
2024-0022
  • Ages 2-5
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CCHMC pediatric dental patients between the ages of 2 years to 5 years and 11months, at the time of recruitment, who present to any CCHMC dental clinic locationand then are found to need full mouth dental rehabilitation.

  • Patients who speak the most common languages at CCHMC will be able to be recruitedfor the study. o English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.

  • These patients must qualify for treatment at the CCHMC dental in-office generalanesthesia (IOGA) area or the Procedure Center (PC). IOGA and the PC will beselected as a venue of treatment to control behavioral factors. This is not specificto the study and would occur due to their treatment needs.

  • Participants will have at least one pair of contralateral primary molars with theneed 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 assignedvia 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 PracticeGuidelines 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 definedby the AAPD

  7. For patients who exhibit high caries risk and whose treatment is performedunder sedation or general anesthesia. This would be normal and not specific tothe study.

  • Participants who consent to the study, and who can be available for follow-up recallappointments.

  • All participants will be ASA I or ASA II as defined by the American Society ofAnesthesiologists.15

Exclusion

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 duringfollow-up visits.

  • Participants who do not speak English, Spanish, Arabic, Uzbek, Nepali, ChineseMandarin, Russian, French.

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: BioFLX
Phase:
Study Start date:
May 17, 2024
Estimated Completion Date:
May 15, 2025

Connect with a study center

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

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