Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-10-31

Brief Summary

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This pilot study aims to compare the clinical and radiographic success of Bioflex (Nusmile) crowns Versus Stainless-steel crowns in restoring decayed primary molars.

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Detailed Description

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Decayed primary teeth must be treated promptly because they are crucial for chewing, speaking, and holding the space for permanent teeth. Losing primary teeth too early can cause various issues, including psychological problems. Hence, restoring decayed primary teeth is an essential aspect of pediatric dentistry Preformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback Parents are increasingly concerned about the appearance of dental restorations for their children and prefer tooth-colored options. To overcome this issue, Nusmile has introduced a new type of crown called "Bioflex". These crowns combine the best qualities of both stainless steel and zirconia crowns, as they are flexible, adaptable, and durable

Conditions

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Restoration of Primary Molars with Bioflex Crowns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Stainless steel crown

Control group

Group Type ACTIVE_COMPARATOR

Stainless steel crowns

Intervention Type OTHER

Preformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback

Bioflex crown

Intervention group

Group Type EXPERIMENTAL

Nusmile bioflex crowns

Intervention Type OTHER

The Bioflex crown is a new synthetic crown that has been introduced in pediatric practice. This crown is believed to offer better adaptation, durability, and ease of handling, along with improved aesthetic properties when compared to conventional crowns

Interventions

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Nusmile bioflex crowns

The Bioflex crown is a new synthetic crown that has been introduced in pediatric practice. This crown is believed to offer better adaptation, durability, and ease of handling, along with improved aesthetic properties when compared to conventional crowns

Intervention Type OTHER

Stainless steel crowns

Preformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical Criteria:

1. Children from age 4-7.
2. Cooperative children and willing for follow-up visits.
3. Mandibular second Primary molars with multi-surface caries
* Radiographic criteria:

1. Mandibular second Primary molars with at least two-thirds of the root remaining.

Exclusion Criteria

* • General Criteria:



1. •Unable to attend follow-up visits
2. •Refuse to participate in the study
3. •Uncooperative child
* Clinical Criteria:

1. • Tooth with grade II or grade III mobility
2. •Children with bruxism
3. • Pulpally involved teeth
* Radiographic Criteria:

1. •Tooth with pathological root resorption
2. •Teeth with root caries

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No