Clinical trial NCT05475145: Sealing of Occlusal Dentin Caries in Primary Molars.
Official title: Resin-based Sealing vs Resin-modified Glass Ionomer Cement for Treatment of Occlusal Dentin Caries in Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries; Dentin
Fissure, Dental
Dental Caries in Children
Glass Ionomer Cement
Fissure Sealants
Keywords: fissure sealant
dental atraumatic restorative treatment
deciduous teeth
glass ionomer cement
Dental Caries in Children
Lead sponsor: Region Östergötland
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2022-07-26
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-blinded randomized split-mouth longitudinal 3 year follow up study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment success without defects after 3 years
timeFrame: 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 outcomes:
measure: Patient preferance
timeFrame: 3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.
measure: Dentist´s preferance
timeFrame: 3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.
measure: Time used for the treatment
timeFrame: 3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.
Other outcomes:
Locations:
Study officials:
affiliation: Linkoeping University
name: Mats A Bågesund, PhD,AssProf
role: STUDY_DIRECTOR
References: