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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Restoration of Primary Molars with Bioflex Crowns

Treatments: Other: Nusmile bioflex crowns; Other: Stainless steel crowns

Study type: Interventional

Funder types: Other

Identifiers

NCT06721741

Bioflex crowns

Details and patient eligibility

About

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

Full 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

Enrollment: 36 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Stainless steel crown

Active Comparator group

Description:

Control group

Treatment:

Other: Stainless steel crowns

Bioflex crown

Experimental group

Description:

Intervention group

Treatment:

Other: Nusmile bioflex crowns