Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique
1 other identifier
interventional
36
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2024
CompletedFirst Posted
Study publicly available on registry
December 6, 2024
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
February 17, 2025
November 1, 2024
1 year
October 2, 2024
February 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Patient relevant criteria
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
1 Year
Secondary Outcomes (1)
Crown Relevant Criteria
1Year
Study Arms (2)
Stainless steel crown
ACTIVE COMPARATORControl group
Bioflex crown
EXPERIMENTALIntervention group
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Clinical Criteria:
- Children from age 4-7.
- Cooperative children and willing for follow-up visits.
- Mandibular second Primary molars with multi-surface caries
- Radiographic criteria:
- Mandibular second Primary molars with at least two-thirds of the root remaining.
You may not qualify if:
- General Criteria:
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- Unable to attend follow-up visits
- Refuse to participate in the study
- Uncooperative child
- Clinical Criteria:
- Tooth with grade II or grade III mobility
- Children with bruxism
- Pulpally involved teeth
- Radiographic Criteria:
- Tooth with pathological root resorption
- Teeth with root caries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 2, 2024
First Posted
December 6, 2024
Study Start
June 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
February 17, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share