Phase
Condition
N/ATreatment
BioFLX
3M Stainless Steel Crown
BioFLX crown
Clinical Study ID
Ages 2-5 All Genders Accepts Healthy Volunteers
Study Summary
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
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 definedby the AAPD
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
Connect with a study center
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
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