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NCT Number: NCT06597669

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

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Key information

Conditions

Caries,Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hue University of Medicine and Pharmacy

Huế, Thừa Thiên Huế Province, 49120, Vietnam

Location status: Recruiting

Location contact

Thanh Thao Nguyen, MD, PhD

CONTACT

[email protected]

+84234 3822 173

Van Nhat Thang Le, DDS, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placement of stainless steel crowns on primary molars

Procedure

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

Primary outcomes

  1. Failure of stainless steel crowns

    Time frame: 3 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.

  2. Failure of stainless steel crowns

    Time frame: 6 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.

  3. Failure of stainless steel crowns

    Time frame: 9 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.

  4. 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

  1. Occlusal contact

    Time frame: 0 months

    Occlusal contact was assessed as follows: normal occlusion or rised occlusion.

  2. Occlusal contact

    Time frame: 3 months

    Occlusal contact was assessed as follows: normal occlusion or rised occlusion.

  3. Occlusal contact

    Time frame: 6 months

    Occlusal contact was assessed as follows: normal occlusion or rised occlusion.

  4. Occlusal contact

    Time frame: 9 months

    Occlusal contact was assessed as follows: normal occlusion or rised occlusion.

  5. Occlusal contact

    Time frame: 12 months

    Occlusal contact was assessed as follows: normal occlusion or rised occlusion.

  6. Periodontal health

    Time frame: 0 months

    • 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.

  7. Periodontal health

    Time frame: 3 months

    • 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.

  8. Periodontal health

    Time frame: 6 months

    • 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. Periodontal health

    Time frame: 9 months

    • 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.

  10. Periodontal health

    Time frame: 12 months

    • 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.

Sponsors and collaborators

Lead sponsor

Hue University of Medicine and Pharmacy

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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