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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06721741
Enrollment
36
Registered
2024-12-06
Start date
2025-06-30
Completion date
2026-10-31
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restoration of Primary Molars with Bioflex Crowns

Brief summary

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

Detailed description

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

Interventions

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

OTHERNusmile 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient relevant criteria1 Year1. Clinically Success if: No clinical signs or symptoms like: * Pain * Dental Abscess/Swelling * Sinus Tract/ Fistula * Mobility 2. Radiographically Success if: No pathology visible on x-ray like: * Internal/External Root Resorption * Peri-radicular Radiolucency * Furcation Involvement * Periapical Pathosis

Secondary

MeasureTime frameDescription
Crown Relevant Criteria1Year• wear of the opposing Binary (yes or no)

Contacts

Primary ContactHajer Ahmed Mousa
hajermousa9@gmail.com01551106855
Backup ContactManal Ahmed Elsayed
01227332259

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026