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SealCar: Sealing of Occlusal Dentin Caries in Primary Molars.

Sponsor
Mats Bågesund (Other)
Overall Status
Completed
CT.gov ID
NCT05475145
Collaborator
Linkoeping University (Other)
70
Enrollment
1
Arm
88.4
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Resin based sealing [RBS]
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Non-blinded randomized split-mouth longitudinal 3 year follow up study.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.
Primary Purpose:
Treatment
Official Title:
Resin-based Sealing vs Resin-modified Glass Ionomer Cement for Treatment of Occlusal Dentin Caries in Primary Molars
Actual Study Start Date :
Feb 2, 2015
Actual Primary Completion Date :
Jun 17, 2021
Actual Study Completion Date :
Jun 17, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Child

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

Procedure: Resin based sealing [RBS]
Other Names:
  • Glassionomer cement [GIC].

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Treatment success without defects after 3 years [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.]

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

    Secondary Outcome Measures

    1. Patient preferance [3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.]

      Comparing patiens´experience on a 7-grade face-scale (Bieri et al.1990) of the two treatments

    2. Dentist´s preferance [3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.]

      Comparing the dentists preferance of the two tretaments methods on a four grade rank-scale from "very bad" to "very good".

    3. Time used for the treatment [3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.]

      Evaluating time used for each of the two different treatment methods - measured in minutes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 9 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mats Bågesund
    • Linkoeping University

    Investigators

    • Study Director: Mats A Bågesund, PhD,AssProf, Linkoping University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mats Bågesund, Associate Professor, Assistant Professor, Senior Consultant Specialist in Pediatric Dentistry, Region Östergötland
    ClinicalTrials.gov Identifier:
    NCT05475145
    Other Study ID Numbers:
    • 2014/297-31
    • #7-15-19, #7-16-7
    • SPF2018
    • #565531, #666761, #862781
    First Posted:
    Jul 26, 2022
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mats Bågesund, Associate Professor, Assistant Professor, Senior Consultant Specialist in Pediatric Dentistry, Region Östergötland
    fissure sealant
    dental atraumatic restorative treatment
    deciduous teeth
    glass ionomer cement
    Dental Caries in Children
    Additional relevant MeSH terms:
    Dental Caries
    Dental Fissures

    Study Results

    No Results Posted as of Jul 26, 2022