Sealing of Occlusal Dentin Caries in Primary Molars.

NCT ID: NCT05475145

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-02
• Study Completion Date: 2022-06-17

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Child

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

Group Type: EXPERIMENTAL

Resin based sealing [RBS]

Intervention Type: PROCEDURE

Interventions

Resin based sealing [RBS]

Intervention Type: PROCEDURE

Other Intervention Names

Glassionomer cement [GIC].

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Mats Bågesund

OTHER

Sponsor Role: lead

Responsible Party

Mats Bågesund

Associate Professor, Assistant Professor, Senior Consultant Specialist in Pediatric Dentistry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mats A Bågesund, PhD,AssProf

Role: STUDY_DIRECTOR

Linkoeping University

Other Identifiers

#7-15-19, #7-16-7

Identifier Type: OTHER

Identifier Source: secondary_id

SPF2018

Identifier Type: OTHER

Identifier Source: secondary_id

#565531, #666761, #862781

Identifier Type: OTHER

Identifier Source: secondary_id

2014/297-31

Identifier Type: -

Identifier Source: org_study_id