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

Not Applicable

Not yet recruiting

• Conditions: Restoration of Primary Molars with Bioflex Crowns

• Registration Number: NCT06721741
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2024-10-02
• Status Verified: 2024-11
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Study Start: 2025-06
• Primary Completion: 2026-06
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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:

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  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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient relevant criteria	1 Year	1. 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 Outcome Measures

Name	Time	Method
Crown Relevant Criteria	1Year	• wear of the opposing Binary (yes or no)