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Completed

NCT Number: NCT05475145

Sealing of Occlusal Dentin Caries in Primary Molars.

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.

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Key information

Conditions

Caries; Dentin Dental Caries in Children Dental Fissures Fissure Sealants Fissure, Dental Glass Ionomer Cement Stomatognathic Diseases Tooth Abnormalities Tooth Diseases

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Resin based sealing [RBS]

Procedure

Other names: Glassionomer cement [GIC].

Primary outcomes

  1. Treatment success without defects after 3 years

    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.

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

Secondary outcomes

  1. Patient preferance

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mats Bågesund

Other

Collaborators

  • Linkoeping University

Registry information

Official study title

Resin-based Sealing vs Resin-modified Glass Ionomer Cement for Treatment of Occlusal Dentin Caries in Primary Molars

Acronym: SealCar

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Jul 26, 2022
Registry last updated
Jul 26, 2022

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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