Sealing of Occlusal Dentin Caries in Primary Molars.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Caries; Dentin, Fissure, Dental, Dental Caries in Children, Glass Ionomer Cement, Fissure Sealants

Intervention / Treatment
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* Procedure: Resin based sealing [RBS]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Non-blinded randomized split-mouth longitudinal 3 year follow up study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Child<br>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]<br> <br> * Other names: Glassionomer cement [GIC].;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preferance | Comparing patiens´experience on a 7-grade face-scale (Bieri et al.1990) of the two treatments | 3 years. From inclusion of first patient until the two treatments have been performed in each of the included children. | 
| Dentist´s preferance | Comparing the dentists preferance of the two tretaments methods on a four grade rank-scale from very bad to very good. | 3 years. From inclusion of first patient until the two treatments have been performed in each of the included children. | 
| Time used for the treatment | Evaluating time used for each of the two different treatment methods - measured in minutes. | 3 years. From inclusion of first patient until the two treatments have been performed in each of the included children. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fissure sealant, dental atraumatic restorative treatment, deciduous teeth, glass ionomer cement, Dental Caries in Children