A 36-Month Prospective Randomized Clinical Pilot Trial Comparing Stainless Steel Crowns with Prefabricated Resin Crowns in Primary Molar Teeth
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Caries
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The United States Public Health Service Restorative criteria
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Patrick Ruck
Primary investigator
Children's Hospital Medical Center, Cincinnati
Eligibility Criteria
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
- •Extensive caries
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.
Outcomes
Primary Outcomes
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