Caries; Dentin, Dental Caries in Children, Fissure, Dental, Fissure Sealants, Glass Ionomer Cement
Conditions
Keywords
fissure sealant, dental atraumatic restorative treatment, deciduous teeth, glass ionomer cement, Dental Caries in Children
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.
Interventions
PROCEDUREResin based sealing [RBS]
Sponsors
Linkoeping University
Mats Bågesund
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
We consider it not possible to mask för participant or care provider.
Intervention model description
Non-blinded randomized split-mouth longitudinal 3 year follow up study.
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Outcome results
None listed