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

NCT06597669 | Recruiting

• 1 other identifier: H2024/097
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Caries,Dental

Keywords

Dental caries; Primary molars; Stainless steel crowns

Outcome Measures

Primary Outcomes (4)

• Failure of stainless steel crowns

  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.

  3 months

• Failure of stainless steel crowns

  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.

  6 months

• Failure of stainless steel crowns

  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.

  9 months

• Failure of stainless steel crowns

  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.

  12 months

Secondary Outcomes (10)

• Occlusal contact

  0 months

• Occlusal contact

  3 months

• Occlusal contact

  6 months

• Occlusal contact

  9 months

• Occlusal contact

  12 months

Study Arms (2)

Conventional Technique

EXPERIMENTAL

A stainless steel crown will place on a carious primary molar after preparation

Procedure: Placement of stainless steel crowns on primary molars

Hall technique

EXPERIMENTAL

A stainless steel crown will place on a carious primary molar without local anesthesia caries removal or any preparation

Procedure: Placement of stainless steel crowns on primary molars

Interventions

Placement of stainless steel crowns on primary molars PROCEDURE

Preformed metal crowns have been placed to treat caries in primary molars

Conventional Technique; Hall technique

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hue University of Medicine and Pharmacy: lead

Study Sites (1)

Hue University of Medicine and Pharmacy

Huế, Thừa Thiên Huế Province, 49120, Vietnam

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 4, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

VN (1)