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| ID | Type | Description | Link |
|---|---|---|---|
| #7-15-19, #7-16-7 | Other Identifier | Public Dental Service Östergötland | |
| SPF2018 | Other Identifier | Swedish Society of Pediatric Dentistry | |
| #565531, #666761, #862781 | Other Identifier | FORSS - Medical Research Council of South-East Sweden. |
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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Child | Experimental | Each patient receives treatment of dental caries in two primary molars using two diffferent methods - Resin based sealing [RBS] or Glassionomer cement [GIC]. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resin based sealing [RBS] | Procedure |
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| 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. |
| 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 |
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Inclusion Criteria:
• primary occlusal dentin caries in two primary molars
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mats A Bågesund, PhD,AssProf | Linkoeping University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41520098 | Derived | Bagesund M, Olson AC, Chizarie S, Omanovic M, Zuber A, Hultquist AI. Resin-based sealing vs resin-modified glass-ionomer filling for treatment of occlusal cavitated dentine caries lesions in primary molars - a multi-center randomized controlled split-mouth 3-year follow-up clinical trial. Eur Arch Paediatr Dent. 2026 Jan 10. doi: 10.1007/s40368-026-01161-7. Online ahead of print. |
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Results will be published on group level and data possible to connect to an individual person will not be presented.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 25, 2024 | |
| Reset | Oct 23, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 25, 2024 | Oct 23, 2024 |
| ID | Term |
|---|---|
| D003750 | Dental Fissures |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Non-blinded randomized split-mouth longitudinal 3 year follow up study.
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We consider it not possible to mask för participant or care provider.
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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. |