Dental Caries Pit and FissurePhase 4FISSURENCT03315312
Occlusal Caries Management in First Permanent Molars in Child Dental Care
A Phase 4 study testing Fluoride Varnishes and Fissure Sealants in people with Dental Caries Pit and Fissure and Dental Caries in Children, run by Oral Health Centre of Expertise in Eastern Norway at 1 site in Norway.
Trial summary
Occlusal caries management in first permanent molars: a pragmatic randomized clinical trial in child dental care Aim of the present study is to evaluate the effectiveness of fissure sealants and fluoride varnish in a pragmatic randomized clinical trial and evaluate whether some specific patient groups benefit more… Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Dental Caries Pit and Fissure, Dental Caries in Children
- What is being tested?
- Fluoride Varnishes and Fissure Sealants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2017to 31 Dec 2023
- Phase
- Phase 4
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The high risk children (having a previous caries experience at 5 years of age) with at least two erupted first permanent molars
Who cannot join
- Children who already developed caries, had restorations or fissure sealants placed in first molars are excluded from the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FISSURE-Project. Improved Dental Decay Management in Dental Service for Children: Fissure Sealants or Fluoride Varnish?
Occlusal caries management in first permanent molars: a pragmatic randomized clinical trial in child dental care
Aim of the present study is to evaluate the effectiveness of fissure sealants and fluoride varnish in a pragmatic randomized clinical trial and evaluate whether some specific patient groups benefit more from any particular treatment.
Read more
The high risk children (having a previous caries experience at 5 years of age) from 2009, 2010 and 2011 birth cohorts (6-, 7- and 8-year-olds) from three counties (Østfold, Oppland and Hedmark) are selected. Children with at least two erupted first permanent molars in the same jaw randomly receive resin-based sealant or a fluoride varnish (Duraphat) during a routine dental examination. Children who already developed caries, had restorations or fissure sealants placed in first molars were excluded from the present study.
Fluoride varnish and resin-based fissure sealants are randomly applied on contra-lateral teeth where each child serves as its own control. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics. The study is approved by the Regional Committee for Medical Research Ethics South East (2016/2002/REK sør-øst C).
Sample size calculations: Based on the assumption that 80% of the treated teeth do not get caries and that 10% difference in caries development constitutes a clinically meaningful difference, it is required to recruit 180 participants in the study for the split-mouth design. Considering a potential maximum of annual 20% drop-out rate and a 3-years follow-up, the study will need to recruit 400 participants in order to have at least 206 children at the 3 years of follow-up.
Treatments are provided by either dentists or dental hygienists during routine dental examinations. Caregivers of eligible children are informed about the study, the participation is voluntary and an informed written parental consent is obtained in accordance with the directions of the Regional Committee for Medical Research Ethics. In this study, a clinician selects a random treatment for the first tooth by choosing one of the two cards, while a collateral tooth receives an alternative treatment. Subsequently, treatments provided and materials used are recorded on a treatment registration form. During this study, clinicians follow their conventional clinical procedures for applying sealants or fluoride varnish. Information on patient's caries experience and quality of oral hygiene are recorded on treatment registration form. Fluoride varnish is applied three times, at baseline, 6 months and 12 months.
Caries on occlusal surfaces of first molars detected at later 24 and 36 months follow-ups will be recorded in the follow-up registration form. The main study outcome is caries occurrence on occlusal tooth surfaces.
- Being tested
- Fluoride Varnishes, Fissure Sealants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride VarnishesDrug
Fluoride varnish is randomly applied on randomly selected first permanent molar. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics.
Fissure SealantsDrug
Resin-based fissure sealant is applied on contra-lateral first permanent molar and each child serves as its own control. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics.
| Study group | Role | What they receive |
|---|---|---|
| Fissure sealant | Active comparator | Not described Receives: Drug: Fissure Sealants |
| Fluoride varnish | Experimental | Not described Receives: Drug: Fluoride Varnishes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental caries incidence on occlusal surfaces of first molars
Decayed, missing and filled surfaces (DMFS) increment
Measured: 12 months after application
Dental caries incidence on occlusal surfaces of first molars
Decayed, missing and filled surfaces (DMFS) increment
Measured: 24 months after application
Dental caries incidence on occlusal surfaces of first molars
Decayed, missing and filled surfaces (DMFS) increment
Measured: 36 months after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Feb 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2023 (estimated)
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 Caries Pit and FissureStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth design
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oral Health Centre of Expertise in Eastern Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Public Dental Service, Hedmark, Public Dental Service, Oppland, Public Dental Service, Østfold
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315312
- Sponsor's protocol ID
- FISSURE
- Acronym
- FISSURE
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2017
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stangvaltaite-Mouhat L, Mdala I, Klepaker IV, Wigen TI, Uhlen-Strand MM, Skudutyte-Rysstad R. Development of a nomogram for prediction of occlusal dentin caries in Norwegian children at risk: a 36-month follow-up study. BMC Oral Health. 2026 Sep 9;26(1):1885. doi: 10.1186/s12903-026-09819-w.
PubMed 42823705
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FISSURE-Project. Improved Dental Decay Management in Dental Service for Children: Fissure Sealants or Fluoride Varnish?
- ClinicalTrials.gov ID
- NCT03315312
- Acronym / sponsor ID
- FISSURE / FISSURE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Oral Health Centre of Expertise in Eastern NorwayUniversity, hospital or other
- Collaborators
- Public Dental Service, Hedmark, Public Dental Service, Oppland, Public Dental Service, Østfold
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Oct 2017 (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.
Occlusal caries management in first permanent molars: a pragmatic randomized clinical trial in child dental care
Aim of the present study is to evaluate the effectiveness of fissure sealants and fluoride varnish in a pragmatic randomized clinical trial and evaluate whether some specific patient groups benefit more from any particular treatment.
The high risk children (having a previous caries experience at 5 years of age) from 2009, 2010 and 2011 birth cohorts (6-, 7- and 8-year-olds) from three counties (Østfold, Oppland and Hedmark) are selected. Children with at least two erupted first permanent molars in the same jaw randomly receive resin-based sealant or a fluoride varnish (Duraphat) during a routine dental examination. Children who already developed caries, had restorations or fissure sealants placed in first molars were excluded from the present study.
Fluoride varnish and resin-based fissure sealants are randomly applied on contra-lateral teeth where each child serves as its own control. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics. The study is approved by the Regional Committee for Medical Research Ethics South East (2016/2002/REK sør-øst C).
Sample size calculations: Based on the assumption that 80% of the treated teeth do not get caries and that 10% difference in caries development constitutes a clinically meaningful difference, it is required to recruit 180 participants in the study for the split-mouth design. Considering a potential maximum of annual 20% drop-out rate and a 3-years follow-up, the study will need to recruit 400 participants in order to have at least 206 children at the 3 years of follow-up.
Treatments are provided by either dentists or dental hygienists during routine dental examinations. Caregivers of eligible children are informed about the study, the participation is voluntary and an informed written parental consent is obtained in accordance with the directions of the Regional Committee for Medical Research Ethics. In this study, a clinician selects a random treatment for the first tooth by choosing one of the two cards, while a collateral tooth receives an alternative treatment. Subsequently, treatments provided and materials used are recorded on a treatment registration form. During this study, clinicians follow their conventional clinical procedures for applying sealants or fluoride varnish. Information on patient's caries experience and quality of oral hygiene are recorded on treatment registration form. Fluoride varnish is applied three times, at baseline, 6 months and 12 months.
Caries on occlusal surfaces of first molars detected at later 24 and 36 months follow-ups will be recorded in the follow-up registration form. The main study outcome is caries occurrence on occlusal tooth surfaces.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Fissure sealant | Active comparator | Drug: Fissure Sealants |
| Fluoride varnish | Experimental | Drug: Fluoride Varnishes |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The high risk children (having a previous caries experience at 5 years of age) with at least two erupted first permanent molars
Key exclusion criteria (1 listed)
- Children who already developed caries, had restorations or fissure sealants placed in first molars are excluded from the present study.
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 |
|---|---|---|
| Fluoride VarnishesFluoride varnish is randomly applied on randomly selected first permanent molar. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics. | Drug | Fluoride varnish |
| Fissure SealantsResin-based fissure sealant is applied on contra-lateral first permanent molar and each child serves as its own control. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics. | Drug | Fissure sealant |
Primary outcome
Dental caries incidence on occlusal surfaces of first molars
Time frame: 12 months after application
Decayed, missing and filled surfaces (DMFS) increment
Dental caries incidence on occlusal surfaces of first molars
Time frame: 24 months after application
Decayed, missing and filled surfaces (DMFS) increment
Dental caries incidence on occlusal surfaces of first molars
Time frame: 36 months after application
Decayed, missing and filled surfaces (DMFS) increment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 42823705Stangvaltaite-Mouhat L, Mdala I, Klepaker IV, Wigen TI, Uhlen-Strand MM, Skudutyte-Rysstad R. Development of a nomogram for prediction of occlusal dentin caries in Norwegian children at risk: a 36-month follow-up study. BMC Oral Health. 2026 Sep 9;26(1):1885. doi: 10.1186/s12903-026-09819-w.
- Individual participant dataSharing planned: No
Related trials for Dental Caries Pit and Fissure
Not yet recruiting
Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
Pit and Fissure Sealant Retention, Dental Caries
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoride Varnishes and Fissure Sealants in people with Dental Caries Pit and Fissure and Dental Caries in Children, run by Oral Health Centre of Expertise in Eastern Norway at 1 site in Norway.
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 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Dental caries incidence on occlusal surfaces of first molars (time frame: 12 months after application). The study lists 3 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 NCT03315312, 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 31 Oct 2023.