Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth

Clinical and Radiographic Success of Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel (3M ESPE) Crowns for Restoration of Primary Molar Teeth: a Split Mouth Randomized Controlled Trial.

The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Tooth Decay
• Intervention / Treatment: Other: Resin polymer (NuSmile Bioflx) crown; Other: Stainless steel crown

Detailed Description

There is a lack of literary evidence for assessment of the properties of Bioflx crowns and their effect on clinical outcomes and parental satisfaction compared to traditionally available options including stainless steel crowns and zirconia crowns. Hence, this study plans to assess the clinical performance and child and parental satisfaction of Bioflx compared to the "gold standard" stainless steel crowns in pediatric patients.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: Children age group 3-7 yrs old
• Primary molars affected with caries or hypoplastic defect.
• Occlusion: Primary molar must have antagonist tooth.
• Consent of parent (legal guardians) and child assent for 7 years.
• Multi-surface dental caries observed in more than one tooth, in either side of the same arch (maxilla or mandible) or opposite arch (maxilla or mandible)
• Status: Asymptomatic or symptomatic teeth with signs of reversible pulpitis

Exclusion Criteria:

• Teeth with advanced stages of resorption (more than 2/3rd)
• Teeth exhibiting irreversible pulpitis.
• Teeth for which pulpotomy is done.
• Molar in infraocclusion
• Medically compromised children (ASA 3 or 4)
• History of grinding or pathological attrition
• Adverse gingival or periodontal conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participants; Each participant will receive a BioFLX crown and a stainless steel crown.	Other: Resin polymer (NuSmile Bioflx) crown; Resin polymer (NuSmile Bioflx)crown; Other: Stainless steel crown; Stainless steel crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments	The clinical outcomes will be measured and reported in the data table based on the number of participants scored on 3-point Likert scale (Ideal, Acceptable, or Not Acceptable) for the following parameters separately: Contour of crown, gingival health, staining of crown, surface roughness of crown, opposing tooth, color match of crown, marginal fit, marginal discoloration, recurrent caries.	3, 6, 12, 18, 24 and 36 months
The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments	The radiographic outcomes will be measured and reported in the data table based on the number of participants scored on either presence or absence (yes / no) of the findings for the following parameter separately: Widening of periodontal ligament space, furcation radiolucency, periapical pathology, alveolar crestal bone loss, internal root resorption and external root resorption.	3, 6, 12, 18, 24 and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental satisfaction	The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.	3, 12, 24 and 36 months
Child satisfaction	The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.	3, 12, 24 and 36 months
ECOHIS (Early Childhood Oral Health Impact Scale) survey	The questionnaire is a Likert scale of 1-5. 1 equals never. 5 equals very often. The lower the score, the better.	Pre-operative, 6, 12, 24 and 36 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: HM20028439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No