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Sealing of Occlusal Dentin Caries in Primary Molars. (SealCar)

Primary Purpose

Caries; Dentin, Fissure, Dental, Dental Caries in Children

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resin based sealing [RBS]
Sponsored by
Mats Bågesund
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries; Dentin focused on measuring fissure sealant, dental atraumatic restorative treatment, deciduous teeth, glass ionomer cement, Dental Caries in Children

Eligibility Criteria

3 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• primary occlusal dentin caries in two primary molars

Exclusion Criteria:

  • Language problems or disabilities
  • Less than 3 years until expected exfoliation
  • Hypomineralization
  • Previous filling or dentin caries
  • Carious cavity >1/3 of occlusal surface
  • Unable to cooperate
  • Appearing caries or filling (on studied tooth) not originating from the studied cavity
  • Tooth exfoliating before end of study
  • Leaving Public dental service or moving out of the region during follow up period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Child

    Arm Description

    Each patient receives treatment of dental caries in two primary molars using two diffferent methods - Resin based sealing [RBS] or Glassionomer cement [GIC].

    Outcomes

    Primary Outcome Measures

    Treatment success without defects after 3 years
    Percentage of treatments (for each of the studied groups) without defects during the 3-year follow up period

    Secondary Outcome Measures

    Patient preferance
    Comparing patiens´experience on a 7-grade face-scale (Bieri et al.1990) of the two treatments
    Dentist´s preferance
    Comparing the dentists preferance of the two tretaments methods on a four grade rank-scale from "very bad" to "very good".
    Time used for the treatment
    Evaluating time used for each of the two different treatment methods - measured in minutes.

    Full Information

    First Posted
    June 17, 2022
    Last Updated
    July 24, 2022
    Sponsor
    Mats Bågesund
    Collaborators
    Linkoeping University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05475145
    Brief Title
    Sealing of Occlusal Dentin Caries in Primary Molars.
    Acronym
    SealCar
    Official Title
    Resin-based Sealing vs Resin-modified Glass Ionomer Cement for Treatment of Occlusal Dentin Caries in Primary Molars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2, 2015 (Actual)
    Primary Completion Date
    June 17, 2021 (Actual)
    Study Completion Date
    June 17, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mats Bågesund
    Collaborators
    Linkoeping University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    BACKGROUND A simple method for arresting dentin caries with a tight seal of the cavity would exclude the need for injection and excavation, reduce the risk for dental fear and possibly postpone or eliminate the need for further treatment. AIM The aim is to evaluate success-rate and children's subjective experience of resin-based sealing (RBS) and resin-modified glass ionomer cement (GIC) for treatment of occlusal dentin caries in primary molars. DESIGN Children aged 2-9 years will be recruited to undergo RBS- or GIC-treatment treatment for occlusal dentin caries in primary molars. A parent will answer the Short Form of Children's Fear Survey (CFSS-DS; parental version). No excavation but etching with 38% phosphoric acid will precede RBS. Topical and local anaesthesia and excavation with high speed bur will precede GIC. Time for treatment will be estimated. The children will rank their experience of each treatment on a 7-grade face scale. The dentist will evaluate the child's experience, cooperation and the overall experience of the treatment on a four-grade scale. The treatment will be evaluated as "without remark" or "defective" after 3, 6, 12, 24 and 36 months. For statistical analysis the Chi-2-test, Wilcoxon-Signed-Rank-test and Paired t-test will be used.
    Detailed Description
    BACKGROUND A simple method for arresting dentin caries with a tight seal of the cavity would exclude the need for injection and excavation, reduce the risk for dental fear and possibly postpone or eliminate the need for further treatment. AIM The aim is to evaluate success-rate and children's subjective experience of resin-based sealing (RBS) and resin-modified glass ionomer cement (GIC) for treatment of occlusal dentin caries in primary molars. DESIGN Up to 300 children aged 2-9 years will be recruited to undergo RBS- or GIC-treatment treatment for occlusal dentin caries in primary molars. A parent will answer the Short Form of Children's Fear Survey (CFSS-DS; parental version). No excavation but etching with 38% phosphoric acid will precede RBS. Topical and local anaesthesia and excavation with high speed bur will precede GIC. Time for treatment will be estimated. The children will rank their experience of each treatment on a 7-grade face scale. The dentist will evaluate the child's experience, cooperation and the overall experience of the treatment on a four-grade scale. The treatment will be evaluated as "without remark" or "defective" after 3, 6, 12, 24 and 36 months. For statistical analysis the Chi-2-test, Wilcoxon-Signed-Rank-test and Paired t-test will be used.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caries; Dentin, Fissure, Dental, Dental Caries in Children, Glass Ionomer Cement, Fissure Sealants
    Keywords
    fissure sealant, dental atraumatic restorative treatment, deciduous teeth, glass ionomer cement, Dental Caries in Children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Non-blinded randomized split-mouth longitudinal 3 year follow up study.
    Masking
    None (Open Label)
    Masking Description
    We consider it not possible to mask för participant or care provider.
    Allocation
    N/A
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Child
    Arm Type
    Experimental
    Arm Description
    Each patient receives treatment of dental caries in two primary molars using two diffferent methods - Resin based sealing [RBS] or Glassionomer cement [GIC].
    Intervention Type
    Procedure
    Intervention Name(s)
    Resin based sealing [RBS]
    Other Intervention Name(s)
    Glassionomer cement [GIC].
    Primary Outcome Measure Information:
    Title
    Treatment success without defects after 3 years
    Description
    Percentage of treatments (for each of the studied groups) without defects during the 3-year follow up period
    Time Frame
    3 years. Evaluation will be performed at each follow up visit - that is after 3 months, 6 months, 12 months ´, 24 months and after 36 months. Registration of possiblöe defects will be performed atv ech visit for each patient for each of the used methods.
    Secondary Outcome Measure Information:
    Title
    Patient preferance
    Description
    Comparing patiens´experience on a 7-grade face-scale (Bieri et al.1990) of the two treatments
    Time Frame
    3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.
    Title
    Dentist´s preferance
    Description
    Comparing the dentists preferance of the two tretaments methods on a four grade rank-scale from "very bad" to "very good".
    Time Frame
    3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.
    Title
    Time used for the treatment
    Description
    Evaluating time used for each of the two different treatment methods - measured in minutes.
    Time Frame
    3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • primary occlusal dentin caries in two primary molars Exclusion Criteria: Language problems or disabilities Less than 3 years until expected exfoliation Hypomineralization Previous filling or dentin caries Carious cavity >1/3 of occlusal surface Unable to cooperate Appearing caries or filling (on studied tooth) not originating from the studied cavity Tooth exfoliating before end of study Leaving Public dental service or moving out of the region during follow up period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mats A Bågesund, PhD,AssProf
    Organizational Affiliation
    Linkoping University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Results will be published on group level and data possible to connect to an individual person will not be presented.

    Learn more about this trial

    Sealing of Occlusal Dentin Caries in Primary Molars.

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