Sealing of Occlusal Dentin Caries in Primary Molars. (SealCar)
Primary Purpose
Caries; Dentin, Fissure, Dental, Dental Caries in Children
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resin based sealing [RBS]
Sponsored by
About this trial
This is an interventional treatment trial for Caries; Dentin focused on measuring fissure sealant, dental atraumatic restorative treatment, deciduous teeth, glass ionomer cement, Dental Caries in Children
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Child
Arm Description
Each patient receives treatment of dental caries in two primary molars using two diffferent methods - Resin based sealing [RBS] or Glassionomer cement [GIC].
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Patient preferance
Comparing patiens´experience on a 7-grade face-scale (Bieri et al.1990) of the two treatments
Dentist´s preferance
Comparing the dentists preferance of the two tretaments methods on a four grade rank-scale from "very bad" to "very good".
Time used for the treatment
Evaluating time used for each of the two different treatment methods - measured in minutes.
Full Information
NCT ID
NCT05475145
First Posted
June 17, 2022
Last Updated
July 24, 2022
Sponsor
Mats Bågesund
Collaborators
Linkoeping University
1. Study Identification
Unique Protocol Identification Number
NCT05475145
Brief Title
Sealing of Occlusal Dentin Caries in Primary Molars.
Acronym
SealCar
Official Title
Resin-based Sealing vs Resin-modified Glass Ionomer Cement for Treatment of Occlusal Dentin Caries in Primary Molars
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2015 (Actual)
Primary Completion Date
June 17, 2021 (Actual)
Study Completion Date
June 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mats Bågesund
Collaborators
Linkoeping University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-blinded randomized split-mouth longitudinal 3 year follow up study.
Masking
None (Open Label)
Masking Description
We consider it not possible to mask för participant or care provider.
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Child
Arm Type
Experimental
Arm Description
Each patient receives treatment of dental caries in two primary molars using two diffferent methods - Resin based sealing [RBS] or Glassionomer cement [GIC].
Intervention Type
Procedure
Intervention Name(s)
Resin based sealing [RBS]
Other Intervention Name(s)
Glassionomer cement [GIC].
Primary Outcome Measure Information:
Title
Treatment success without defects after 3 years
Description
Percentage of treatments (for each of the studied groups) without defects during the 3-year follow up period
Time Frame
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 Measure Information:
Title
Patient preferance
Description
Comparing patiens´experience on a 7-grade face-scale (Bieri et al.1990) of the two treatments
Time Frame
3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.
Title
Dentist´s preferance
Description
Comparing the dentists preferance of the two tretaments methods on a four grade rank-scale from "very bad" to "very good".
Time Frame
3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.
Title
Time used for the treatment
Description
Evaluating time used for each of the two different treatment methods - measured in minutes.
Time Frame
3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats A Bågesund, PhD,AssProf
Organizational Affiliation
Linkoping University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Results will be published on group level and data possible to connect to an individual person will not be presented.
Learn more about this trial
Sealing of Occlusal Dentin Caries in Primary Molars.
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