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Compares treatment options for Dental Caries
Official title Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth
ClinicalTrials.gov ID: NCT06713330
What this study is testing
- What it's testing
- 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 5. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
- 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...
- 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
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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
- 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 defined by the AAPD
- 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 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 5 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.