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

NCT06713330 | Recruiting FDA Device

• 1 other identifier: 2024-0022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries

Keywords

Pediatric dentistry

Outcome Measures

Primary Outcomes (1)

• The United States Public Health Service Restorative criteria

  Study criteria being selected would be: Gingival Health, Plaque retention, Occlusal wear, and crown retention as defined by the following Alpha, Bravo, Charlie. Gingival Health according to the Modified Gingival Index (MGI): Alpha (A) normal gingiva Bravo (B) mild inflammation: Charlie (C) moderate inflammation Plaque Retention according to the Simplified Oral Hygiene Index (OHI -S): Alpha (A) 0, 1 Bravo (B)2 Charlie (C) 3 Occlusal Wear: Alpha (A) occlusal surface intact Bravo (B) wear of occlusal surface without tooth surface exposure Charlie (C) wear of occlusal surface with tooth surface exposure. Crown retention: Alpha (A) Intact crown Bravo (B) partial loss of crown material Charlie (C) Crown lost

  36 months

Study Arms (2)

SSC

OTHER

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.

Device: 3M Stainless Steel Crown

BioFLX Crown

EXPERIMENTAL

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.

Device: BioFLX crown

Interventions

BioFLX crown DEVICE

Device: BioFLX crown

BioFLX Crown

3M Stainless Steel Crown DEVICE

3M Stainless Steel Crown

SSC

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify 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 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.
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Patrick Ruck, DDS

CONTACT

7575602623; Patrick.ruck@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Model Details: The purpose of this 36-month prospective, randomized controlled, split-mouth pilot study, is to compare a new prefabricated resin crown material against the gold standard stainless steel crown in primary molars that require full coverage restorations. The results of this study can help determine if resin polymer crowns clinically perform like stainless steel crowns, and if they are an acceptable esthetic alternative treatment option for a full coverage restoration of a primary molar.

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: May 17, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)