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

December 5, 2024 updated by: Patrick Ruck, Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion 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.

    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

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 during follow-up visits.
    • Participants who do not speak English, Spanish, Arabic, Uzbek, Nepali, Chinese Mandarin, Russian, French.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Device: 3M Stainless Steel Crown
3M Stainless Steel Crown
Experimental: 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.
Device: BioFLX crown
Device: BioFLX crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The United States Public Health Service Restorative criteria
Time Frame: 36 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

May 17, 2024

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It can be if needed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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