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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Restoration of Primary Molars with Bioflex Crowns
• Intervention / Treatment: Other: Stainless steel crowns; Other: Nusmile bioflex crowns

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

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hajer Ahmed Mousa; Phone Number: 01551106855; Email: hajermousa9@gmail.com
• Study Contact Backup: Name: Manal Ahmed Elsayed; Phone Number: 01227332259

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stainless steel crown; Control group	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
Experimental: Bioflex crown; Intervention group	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient relevant criteria	Clinically Success if:No clinical signs or symptoms like:PainDental Abscess/SwellingSinus Tract/ FistulaMobility; Radiographically Success if: No pathology visible on x-ray like: Internal/External Root Resorption; Peri-radicular Radiolucency; Furcation Involvement; Periapical Pathosis	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crown Relevant Criteria	• wear of the opposing Binary (yes or no)	1Year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Bioflex crowns

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No