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Completed

NCT Number: NCT06354634

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Decay Tooth Demineralization Tooth Diseases

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resin polymer (NuSmile Bioflx) crown

Other

Resin polymer (NuSmile Bioflx)crown

Stainless steel crown

Other

Stainless steel crown

Primary outcomes

  1. The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments

    Time frame: 3, 6, 12, 18, 24 and 36 months

    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.

  2. The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments

    Time frame: 3, 6, 12, 18, 24 and 36 months

    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.

Secondary outcomes

  1. Parental satisfaction

    Time frame: 3, 12, 24 and 36 months

    The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.

  2. Child satisfaction

    Time frame: 3, 12, 24 and 36 months

    The questionnaire is a Likert scale of 1-5. 1 equals very dissatisfied. 5 equals very satisfied. The higher the score, the better.

  3. ECOHIS (Early Childhood Oral Health Impact Scale) survey

    Time frame: Pre-operative, 6, 12, 24 and 36 months

    The questionnaire is a Likert scale of 1-5. 1 equals never. 5 equals very often. The lower the score, the better.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2024
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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