Sealing of Occlusal Dentin Caries in Primary Molars.

Dental Caries in Children Clinical Trial

— SealCar  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

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

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.