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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06597669
Enrollment
100
Registered
2024-09-19
Start date
2024-09-04
Completion date
2026-05-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries,Dental

Keywords

Dental caries, Primary molars, Stainless steel crowns

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

Interventions

PROCEDUREPlacement of stainless steel crowns on primary molars

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

Sponsors

Hue University of Medicine and Pharmacy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Failure of stainless steel crowns3 monthsLevel 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

MeasureTime frameDescription
Occlusal contact0 monthsOcclusal contact was assessed as follows: normal occlusion or rised occlusion.
Periodontal health0 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.

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026