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

Not Applicable

Recruiting

• Conditions: Caries,Dental
• Interventions: Procedure: Placement of stainless steel crowns on primary molars

• Registration Number: NCT06597669
• Lead Sponsor: Hue University of Medicine and Pharmacy

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-04
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-16
• Last Update Submitted: 2024-09-16
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-03
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)
2. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Technique	Placement of stainless steel crowns on primary molars	A stainless steel crown will place on a carious primary molar after preparation
Hall technique	Placement of stainless steel crowns on primary molars	A stainless steel crown will place on a carious primary molar without local anesthesia caries removal or any preparation

Primary Outcome Measures

Name	Time	Method
Failure of stainless steel crowns	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 Outcome Measures

Name	Time	Method
Occlusal contact	12 months	Occlusal contact was assessed as follows: normal occlusion or rised occlusion.
Periodontal health	12 months	* Plaque index 0 = No plaque in the gingival area.; 1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.; 2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.; 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.; * Gingival index 0 = Normal gingiva; 1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing; 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing; 3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.

Trial Locations

Locations (1)

Hue University of Medicine and Pharmacy; 🇻🇳 Huế, Thua Thien Hue, Vietnam