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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Dental Caries; Tooth Decay

Treatments: Other: Stainless steel crown; Other: Resin polymer (NuSmile Bioflx) crown

Study type: Interventional

Funder types: Other

Identifiers

NCT06354634

HM20028439

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

All participants

Experimental group

Description:

Each participant will receive a BioFLX crown and a stainless steel crown.

Treatment:

Other: Resin polymer (NuSmile Bioflx) crown

Other: Stainless steel crown