Caries; DentinSealCarNCT05475145
Sealing of Occlusal Dentin Caries in Primary Molars.
A study testing Resin based sealing [RBS] in people with Caries; Dentin and Fissure, Dental, run by Mats Bågesund.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries; Dentin, Fissure, Dental, Dental Caries in Children
- What is being tested?
- Resin based sealing [RBS]
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2015to 17 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- primary occlusal dentin caries in two primary molars
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- Resin based sealing [RBS]
- Keywords
- fissure sealant, dental atraumatic restorative treatment, deciduous teeth, glass ionomer cement, Dental Caries in Children
- Medical subject headings
- Dental Fissures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin based sealing [RBS]Procedure or surgery
Also called Glassionomer cement [GIC].
| Study group | Role | What they receive |
|---|---|---|
| Child | Experimental | Each patient receives treatment of dental caries in two primary molars using two diffferent methods - Resin based sealing [RBS] or Glassionomer cement [GIC]. Receives: Procedure: Resin based sealing [RBS] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (3)
Patient preferance
Comparing patiens´experience on a 7-grade face-scale (Bieri et al.1990) of the two treatments
Measured: 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".
Measured: 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.
Measured: 3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start2 Feb 2015
- Primary completion17 Jun 2021
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries; DentinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-blinded randomized split-mouth longitudinal 3 year follow up study.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mats Bågesund
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Sponsor-investigator, Mats Bågesund, Region Östergötland
- Investigators
- Mats A Bågesund, PhD,AssProf, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475145
- Sponsor's protocol ID
- 2014/297-31
- Other IDs
- #7-15-19, #7-16-7, SPF2018, #565531, #666761, #862781
- Acronym
- SealCar
- Status last verified
- Jul 2022
- First submitted
- 17 Jun 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published on group level and data possible to connect to an individual person will not be presented.
Publications
Bagesund M, Olson AC, Chizarie S, Omanovic M, Zuber A, Hultquist AI. Resin-based sealing vs resin-modified glass-ionomer filling for treatment of occlusal cavitated dentine caries lesions in primary molars - a multi-center randomized controlled split-mouth 3-year follow-up clinical trial. Eur Arch Paediatr Dent. 2026 Jan 10. doi: 10.1007/s40368-026-01161-7. Online ahead of print.
PubMed 41520098
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resin-based Sealing vs Resin-modified Glass Ionomer Cement for Treatment of Occlusal Dentin Caries in Primary Molars
- ClinicalTrials.gov ID
- NCT05475145
- Acronym / sponsor ID
- SealCar / 2014/297-31
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mats BågesundUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-blinded randomized split-mouth longitudinal 3 year follow up study.
| Arm | Type | Receives |
|---|---|---|
| Child | Experimental | Procedure: Resin based sealing [RBS]Each patient receives treatment of dental caries in two primary molars using two diffferent methods - Resin based sealing [RBS] or Glassionomer cement [GIC]. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- primary occlusal dentin caries in two primary molars
Key exclusion criteria (9 listed)
- Language problems or disabilities
- Less than 3 years until expected exfoliation
- Hypomineralization
- Previous filling or dentin caries
- Carious cavity >1/3 of occlusal surface
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resin based sealing [RBS]Also: Glassionomer cement [GIC]. | Procedure or surgery | Child |
Primary outcome
Treatment success without defects after 3 years
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.
Percentage of treatments (for each of the studied groups) without defects during the 3-year follow up period
3 secondary outcomes
Patient preferance
Time frame: 3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.
Dentist´s preferance
Time frame: 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
Time frame: 3 years. From inclusion of first patient until the two treatments have been performed in each of the included children.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 41520098Bagesund M, Olson AC, Chizarie S, Omanovic M, Zuber A, Hultquist AI. Resin-based sealing vs resin-modified glass-ionomer filling for treatment of occlusal cavitated dentine caries lesions in primary molars - a multi-center randomized controlled split-mouth 3-year follow-up clinical trial. Eur Arch Paediatr Dent. 2026 Jan 10. doi: 10.1007/s40368-026-01161-7. Online ahead of print.
- Individual participant dataSharing planned: No. Results will be published on group level and data possible to connect to an individual person will not be presented.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mats A Bågesund, PhD,AssProf study director
Linkoeping University
Questions about this trial
What is this clinical trial studying?
A study testing Resin based sealing [RBS] in people with Caries; Dentin and Fissure, Dental, run by Mats Bågesund.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success without defects after 3 years (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05475145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.