Comparing Stainless Steel Crowns with Prefabricated Resin Crowns in Primary Molar Teeth
NCT ID: NCT06713330
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-05-17
2025-05-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
3M Stainless Steel Crown
3M Stainless Steel Crown
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.
BioFLX crown
Device: BioFLX crown
Interventions
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BioFLX crown
Device: BioFLX crown
3M Stainless Steel Crown
3M Stainless Steel Crown
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
5 Years
ALL
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Patrick Ruck
Primary investigator
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Patrick T Ruck
Role: primary
Other Identifiers
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2024-0022
Identifier Type: -
Identifier Source: org_study_id