RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-17

Study Completion:2025-05-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06713330

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 5 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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. * 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 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 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.

Inclusion Criteria

Exclusion 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.
* 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
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 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.

Contacts and Locations

Study Contact

Patrick Ruck, DDS

CONTACT

7575602623

Patrick.ruck@cchmc.org

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-17

Study Completion Date2025-05-15

Study Record Updates

Study Start Date2024-05-17

Study Completion Date2025-05-15

Terms related to this study

Keywords Provided by Researchers

Pediatric dentistry

Additional Relevant MeSH Terms

Dental Caries