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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children; Caries; Dentin; Fissure Sealants; Fissure, Dental; Glass Ionomer Cement
• Intervention / Treatment: Procedure: Resin based sealing [RBS]

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Child; Each patient receives treatment of dental caries in two primary molars using two diffferent methods - Resin based sealing [RBS] or Glassionomer cement [GIC].	Procedure: Resin based sealing [RBS]; Other Names: Glassionomer cement [GIC].

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Mats Bågesund
• Collaborators: Linkoeping University
• Investigators: Study Director: Mats A Bågesund, PhD,AssProf, Linköping University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2015
• Primary Completion (ACTUAL): June 17, 2021
• Study Completion (ACTUAL): June 17, 2022

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: July 24, 2022
• First Posted (ACTUAL): July 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 24, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Dental Caries in Children; fissure sealant; glass ionomer cement; dental atraumatic restorative treatment; deciduous teeth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Dental Fissures
• Other Study ID Numbers: 2014/297-31; #7-15-19, #7-16-7 (OTHER: Public Dental Service Östergötland); SPF2018 (OTHER: Swedish Society of Pediatric Dentistry); #565531, #666761, #862781 (OTHER: FORSS - Medical Research Council of South-East Sweden.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will be published on group level and data possible to connect to an individual person will not be presented.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No