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Clinical Trials/NCT06597669
NCT06597669
Recruiting
Not Applicable

Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars

Hue University of Medicine and Pharmacy1 site in 1 country100 target enrollmentSeptember 4, 2024
ConditionsCaries,Dental

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caries,Dental
Sponsor
Hue University of Medicine and Pharmacy
Enrollment
100
Locations
1
Primary Endpoint
Failure of stainless steel crowns
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Stainless steel crowns have shown high success in restoring carious primary molars over a longer period of time than conventional restorations. This study aims to evaluate the treatment effectiveness of conventional SSCs restoration and Hall technique in treating carious primary molars

Registry
clinicaltrials.gov
Start Date
September 4, 2024
End Date
May 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Le Van Nhat Thang

Lecturer

Hue University of Medicine and Pharmacy

Eligibility Criteria

Inclusion Criteria

  • Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)
  • Children have a primary molar with at least 2 carious lesions corresponding to International Caries Detection and Assessment System (ICDAS) scores 4 or at least 1 carious lesion corresponding to ICDAS scores 5 and 6.

Exclusion Criteria

  • Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders.
  • Children are allergic to nickel and resin.
  • Children unable to return for recall visits.
  • Primary molar has signs of pulpal/periapical diseases (irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess).
  • Children are undergoing orthodontic treatment with fixed or removable appliances.

Outcomes

Primary Outcomes

Failure of stainless steel crowns

Time Frame: 12 months

Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.

Secondary Outcomes

  • Occlusal contact(12 months)
  • Periodontal health(12 months)

Study Sites (1)

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