Sealing of Occlusal Dentin Caries in Primary Molars. (SealCar)

Mats Bågesund

Status: Completed

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

Treatments: Procedure: Resin based sealing [RBS]

Study type: Interventional

Funder types: Other

Identifiers

NCT05475145

2014/297-31

#7-15-19, #7-16-7 (Other Identifier)

SPF2018 (Other Identifier)

#565531, #666761, #862781 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Child

Experimental group

Description:

Each patient receives treatment of dental caries in two primary molars using two diffferent methods - Resin based sealing \[RBS\] or Glassionomer cement \[GIC\].

Treatment:

Procedure: Resin based sealing [RBS]