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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-07

Study Completion Date

2025-02-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dental Caries Tooth Decay

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each participant will receive both interventions.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All participants

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

Group Type EXPERIMENTAL

Resin polymer (NuSmile Bioflx) crown

Intervention Type OTHER

Resin polymer (NuSmile Bioflx)crown

Stainless steel crown

Intervention Type OTHER

Stainless steel crown

Interventions

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Resin polymer (NuSmile Bioflx) crown

Resin polymer (NuSmile Bioflx)crown

Intervention Type OTHER

Stainless steel crown

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No