Dental CariesSEAL-DKNCT02573090
Sealing Manifest Occlusal Caries Lesions in the Permanent Dentition
A study testing Non-invasive resin based fissure sealing and Invasive resin based restoration in people with Dental Caries, run by University of Copenhagen.
Trial summary
The research project "SEAL-DK" is focusing on advantages and disadvantages of two treatment strategies: non-invasive fissure sealing and invasive restorative treatment of manifest occlusal caries lesions in permanent teeth in children and adolescents. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Non-invasive resin based fissure sealing and Invasive resin based restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 521 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Dec 2020
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- each patient should have one manifest occlusal caries lesion in need of restorative treatment
- the radiographic depth of the lesion should be limited to half through the dentin
- written informed consent from children and parents should be obtained before treatment
Who cannot join
- when the occlusal lesion had communication with an approximal caries lesion or occlusal/approximal restoration
- the tooth was hypomineralized
- in case of serious chronic diseases affecting the caries experience and activity
About this study
Official title: SEAL-DK: Sealing Manifest Occlusal Caries Lesions in the Permanent Dentition in Children and Adolescents. RCT
The research project "SEAL-DK" is focusing on advantages and disadvantages of two treatment strategies: non-invasive fissure sealing and invasive restorative treatment of manifest occlusal caries lesions in permanent teeth in children and adolescents. The purpose of the project is to promote the understanding of the possibilities of non-invasive treatment of occlusal caries lesions in the permanent dentition, and to increase the present knowledge about the optimal threshold for sealing or restoration, respectively, when treating such lesions.
The project is carried out as a randomized study of the two treatment strategies: non-invasive versus invasive treatment of occlusal caries. When organizing the study, it is emphasized that no treatment shall be carried out, if conflicting the participating dentists' perception of clinically proper caries treatment, and that the results shall have a high reliability and consistency.
The hypothesis is that caries progression can be stopped by non-invasive fissure sealing changing the threshold and postponing the time for invasive restoration.
Read the detailed description
Background: The first restoration is fatal for the prognosis of the tooth. Studies have shown that caries progression can be stopped with a tight sealing which may even lead to re-mineralization of lesions.
Aim: To investigate the possibility of treating manifest occlusal caries with non-invasive sealing instead of conventional resin restoration.
Study design: the study is carried out as a prospective, randomized clinical study (RCT). Primary, occlusal caries lesions in 521 patients, aged 6-17 years old were treated by non-invasive resin based sealing (n= 368) or resin based restoration (n=153). The dentists or patients were not free to choose the treatment type. Randomization between sealing and restoration (2:1) was made by computer for each practitioner at the University of Copenhagen and kept at the clinics in sealed envelopes. The treatments are examined clinically and radiographically after 1, 2, 3, 5, 7 and 10 years. The treatments are performed and controlled by 68 general practitioners from Public Dental Health Care Service in 9 Danish municipalities.
Sealing: The dentists use material of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen.
Restoration: The dentists use preparation design and material of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen.
The prevalence of regression, arrest and progression of sealed and restored caries lesions, are computed and related to the clinical and radiological registrations of patient, dentist or treatment related factors for assessing of statistically significant correlations.
The influence of each factor on the quality, longevity and need for retreatment of occlusal sealants and restorations, will be assessed using non-parametric tests and Kaplan-Meier survival analyses for statistical treatment of data, supplemented with summarizing multivariate survival analyses such as the Cox regression model and discriminatory analyses.
- Conditions
- Dental Caries
- Being tested
- Non-invasive resin based fissure sealing, Invasive resin based restoration
- Keywords
- Occlusal caries, Resin based fissure sealant, Composite resin restoration, Effectiveness, Longevity
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive resin based fissure sealingProcedure or surgery
Also called Sealing
The dentists use resin based fissure sealants of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen, DK
Invasive resin based restorationProcedure or surgery
Also called Restoration
The dentists use preparation design and resin composites of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen, DK
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive resin based fissure sealing | Experimental | Application of resin based fissure sealing after acid etching of carious occlusal surface Receives: Procedure: Non-invasive resin based fissure sealing |
| Invasive resin based restoration | Active comparator | Application of resin based resin restoration after operative intervention of caries lesion, excavation and preparation on occlusal surface Receives: Procedure: Invasive resin based restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of fissure sealants
Radiographical scoring system:
- Regression in depth of lesion (success) 2: Unchanged depth of lesion (success) 3: Progression in depth of lesion (failure)
Measured: 10 years
Longevity of fissure sealants
Clinical scoring system:
- Intact sealing without caries progression (success) 2: Loss of sealant with or without caries progression (failure)
Measured: 10 years
Secondary outcomes (2)
Effectiveness of resin based restoration
Radiographical scoring system:
- Unchanged depth of lesion (success) 2: Progression in depth of lesion (failure)
Measured: 10 years
Longevity of resin based restoration
Clinical scoring system:
- Intact restoration without caries progression (success) 2: Defect restoration with or without caries progression (failure)
Measured: 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startNov 2006
- Primary completionOct 2020
- Study completionDec 2020
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 Dental CariesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Public Dental Health Care System, Denmark
- Responsible party
- Principal investigator, Azam Bakhshandeh, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573090
- Sponsor's protocol ID
- UCopenhagen1
- Acronym
- SEAL-DK
- Status last verified
- Apr 2021
- First submitted
- 8 Oct 2015
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bakhshandeh A, Qvist V. To Seal or Restore Occlusal Caries in Permanent Molar Teeth, 11-Year RCT. Caries Res. 2025;59(6):544-557. doi: 10.1159/000544980. Epub 2025 Mar 18.
PubMed 40101699
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEAL-DK: Sealing Manifest Occlusal Caries Lesions in the Permanent Dentition in Children and Adolescents. RCT
- ClinicalTrials.gov ID
- NCT02573090
- Acronym / sponsor ID
- SEAL-DK / UCopenhagen1
- Conditions
- Dental Caries
- Keywords
- Occlusal caries, Resin based fissure sealant, Composite resin restoration, Effectiveness, Longevity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Public Dental Health Care System, Denmark
- Study start
- Nov 2006
- Primary completion
- Oct 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 9 Oct 2015 (estimated)
- 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.
The research project "SEAL-DK" is focusing on advantages and disadvantages of two treatment strategies: non-invasive fissure sealing and invasive restorative treatment of manifest occlusal caries lesions in permanent teeth in children and adolescents. The purpose of the project is to promote the understanding of the possibilities of non-invasive treatment of occlusal caries lesions in the permanent dentition, and to increase the present knowledge about the optimal threshold for sealing or restoration, respectively, when treating such lesions.
The project is carried out as a randomized study of the two treatment strategies: non-invasive versus invasive treatment of occlusal caries. When organizing the study, it is emphasized that no treatment shall be carried out, if conflicting the participating dentists' perception of clinically proper caries treatment, and that the results shall have a high reliability and consistency.
The hypothesis is that caries progression can be stopped by non-invasive fissure sealing changing the threshold and postponing the time for invasive restoration.
Detailed description
Background: The first restoration is fatal for the prognosis of the tooth. Studies have shown that caries progression can be stopped with a tight sealing which may even lead to re-mineralization of lesions.
Aim: To investigate the possibility of treating manifest occlusal caries with non-invasive sealing instead of conventional resin restoration.
Study design: the study is carried out as a prospective, randomized clinical study (RCT). Primary, occlusal caries lesions in 521 patients, aged 6-17 years old were treated by non-invasive resin based sealing (n= 368) or resin based restoration (n=153). The dentists or patients were not free to choose the treatment type. Randomization between sealing and restoration (2:1) was made by computer for each practitioner at the University of Copenhagen and kept at the clinics in sealed envelopes. The treatments are examined clinically and radiographically after 1, 2, 3, 5, 7 and 10 years. The treatments are performed and controlled by 68 general practitioners from Public Dental Health Care Service in 9 Danish municipalities.
Sealing: The dentists use material of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen.
Restoration: The dentists use preparation design and material of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen.
The prevalence of regression, arrest and progression of sealed and restored caries lesions, are computed and related to the clinical and radiological registrations of patient, dentist or treatment related factors for assessing of statistically significant correlations.
The influence of each factor on the quality, longevity and need for retreatment of occlusal sealants and restorations, will be assessed using non-parametric tests and Kaplan-Meier survival analyses for statistical treatment of data, supplemented with summarizing multivariate survival analyses such as the Cox regression model and discriminatory analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive resin based fissure sealing | Experimental | Procedure: Non-invasive resin based fissure sealingApplication of resin based fissure sealing after acid etching of carious occlusal surface |
| Invasive resin based restoration | Active comparator | Procedure: Invasive resin based restorationApplication of resin based resin restoration after operative intervention of caries lesion, excavation and preparation on occlusal surface |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- each patient should have one manifest occlusal caries lesion in need of restorative treatment
- the radiographic depth of the lesion should be limited to half through the dentin
- written informed consent from children and parents should be obtained before treatment
Key exclusion criteria (3 listed)
- when the occlusal lesion had communication with an approximal caries lesion or occlusal/approximal restoration
- the tooth was hypomineralized
- in case of serious chronic diseases affecting the caries experience and activity
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 |
|---|---|---|
| Non-invasive resin based fissure sealingAlso: SealingThe dentists use resin based fissure sealants of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen, DK | Procedure or surgery | Non-invasive resin based fissure sealing |
| Invasive resin based restorationAlso: RestorationThe dentists use preparation design and resin composites of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen, DK | Procedure or surgery | Invasive resin based restoration |
Primary outcome
Effectiveness of fissure sealants
Time frame: 10 years
Radiographical scoring system: 1) Regression in depth of lesion (success) 2: Unchanged depth of lesion (success) 3: Progression in depth of lesion (failure)
Longevity of fissure sealants
Time frame: 10 years
Clinical scoring system: 1) Intact sealing without caries progression (success) 2: Loss of sealant with or without caries progression (failure)
2 secondary outcomes
Effectiveness of resin based restoration
Time frame: 10 years
Longevity of resin based restoration
Time frame: 10
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 3 May 2021.
- Derived from this study: PubMed 40101699Bakhshandeh A, Qvist V. To Seal or Restore Occlusal Caries in Permanent Molar Teeth, 11-Year RCT. Caries Res. 2025;59(6):544-557. doi: 10.1159/000544980. Epub 2025 Mar 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive resin based fissure sealing and Invasive resin based restoration in people with Dental Caries, run by University of Copenhagen.
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 3 inclusion and 3 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 3 May 2021. 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?
Effectiveness of fissure sealants (time frame: 10 years). The study lists 2 primary outcomes in all. 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 NCT02573090, 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 3 May 2021.