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

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

Study Overview

• Status: Recruiting
• Conditions: Caries,Dental
• Intervention / Treatment: Procedure: Placement of stainless steel crowns on primary molars

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Thua Thien Hue
    • Huế, Thua Thien Hue, Vietnam, 49120
      • Recruiting
      • Hue University of Medicine and Pharmacy
      • Contact: Thanh Thao Nguyen, MD, PhD; Phone Number: +84234 3822 173; Email: stir@huemed-univ.edu.vn
      • Contact: Van Nhat Thang Le, DDS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional Technique; A stainless steel crown will place on a carious primary molar after preparation	Procedure: Placement of stainless steel crowns on primary molars; Preformed metal crowns have been placed to treat caries in primary molars
Experimental: Hall technique; 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; Preformed metal crowns have been placed to treat caries in primary molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occlusal contact	Occlusal contact was assessed as follows: normal occlusion or rised occlusion.	0 months
Occlusal contact	Occlusal contact was assessed as follows: normal occlusion or rised occlusion.	3 months
Occlusal contact	Occlusal contact was assessed as follows: normal occlusion or rised occlusion.	6 months
Occlusal contact	Occlusal contact was assessed as follows: normal occlusion or rised occlusion.	9 months
Occlusal contact	Occlusal contact was assessed as follows: normal occlusion or rised occlusion.	12 months
Periodontal health	Plaque index 0 = No plaque in the gingival area.= 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.= 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.= Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.; Gingival index 0 = Normal gingiva= Mild inflammation - slight change in color, slight oedema. No bleeding on probing= Moderate inflammation-redness, oedema and glazing. Bleeding on probing= Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.	0 months
Periodontal health	Plaque index 0 = No plaque in the gingival area.= 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.= 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.= Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.; Gingival index 0 = Normal gingiva= Mild inflammation - slight change in color, slight oedema. No bleeding on probing= Moderate inflammation-redness, oedema and glazing. Bleeding on probing= Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.	3 months
Periodontal health	Plaque index 0 = No plaque in the gingival area.= 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.= 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.= Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.; Gingival index 0 = Normal gingiva= Mild inflammation - slight change in color, slight oedema. No bleeding on probing= Moderate inflammation-redness, oedema and glazing. Bleeding on probing= Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.	6 months
Periodontal health	Plaque index 0 = No plaque in the gingival area.= 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.= 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.= Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.; Gingival index 0 = Normal gingiva= Mild inflammation - slight change in color, slight oedema. No bleeding on probing= Moderate inflammation-redness, oedema and glazing. Bleeding on probing= Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.	9 months
Periodontal health	Plaque index 0 = No plaque in the gingival area.= 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.= 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.= Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.; Gingival index 0 = Normal gingiva= Mild inflammation - slight change in color, slight oedema. No bleeding on probing= Moderate inflammation-redness, oedema and glazing. Bleeding on probing= Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.	12 months

Collaborators and Investigators

• Sponsor: Hue University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Dental caries; Primary molars; Stainless steel crowns
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: H2024/097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will plan to share information when finishing study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No