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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05475145
Other study ID # 2014/297-31
Secondary ID #7-15-19, #7-16-
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2015
Est. completion date June 17, 2022

Study information

Verified date July 2022
Source Region Östergötland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date June 17, 2022
Est. primary completion date June 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 9 Years
Eligibility 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

Study Design


Intervention

Procedure:
Resin based sealing [RBS]


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Mats Bågesund Linkoeping University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
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