Caries,DentalNCT06684405
Fluoridated Milk and Enamel Caries in Adolescents
A study testing sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13) in people with Caries,Dental, run by Malmö University at 1 site in Sweden.
Trial summary
The goal of this trial is to investigate whether low daily doses of fluoridated milk, in addition to oral hygiene routines with fluoridated toothpaste, can prevent caries development in adolescents' teeth. Read more about this study
- Who is it for?
- Ages 12 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2012to Jun 2023
- 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 12 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- adolescents of both sexes, aged 12-¬13
- healthy (no oral disease or systemic disease possibly affecting the oral cavity). Health declaration used in the dental clinic was utilized to confirm health status
- adolescents with permanent posterior teeth/no primary molar teeth present and second premolars in contact with the mesial surface of the first molars
- adolescents who, together with their parents or guardians, gave informed written consent to participate. Data confidentiality and the right to withdraw from the study at any time were warranted to the adolescents in writing.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluoridated Milk is Effective in Prevention of Enamel Caries in Adolescents
The goal of this trial is to investigate whether low daily doses of fluoridated milk, in addition to oral hygiene routines with fluoridated toothpaste, can prevent caries development in adolescents' teeth. The main questions it aims to answer are:
- Does fluoridated milk lower the number of caries lesions in teeth over time?
- Does fluoridated milk lower the number of enamel caries lesions over time? Researchers will compare an intervention group receiving doses of fluoride in water to add to milk and a control group receiving water to add to milk.
Read more
The 12-13 year participants will:
- be examined at a baseline and once yearly up to 2 years
- be provided directly with the doses every second month at their dental clinic
- take the fluid daily
Read the detailed description
During the study, the participants were asked to continue with their usual oral hygiene regimes, including tooth-brushing twice a day with toothpaste containing fluorides as recommended by the Swedish National Board of Health and Welfare.
At their yearly visit to their dental clinic the participants were asked about their health status, use of antibiotics, lactose intolerance, daily consumption of milk, tooth brushing frequency, type of toothpaste and use of other fluoride additives. Information on adverse effects (dental pain, visit to other dental clinic, and antibiotics due to dental infection) was collected.
Caries registration was performed by visual-tactile and radiographic examinations at baseline and 1 and 2 years. Visual-tactile examination was performed by a dental practitioner under lighting with a mirror and occasionally with a probe. Caries status was classified for the occlusal/incisal, buccal and lingual surfaces and the proximal surfaces of incisors and cuspids according to the ICDAS criteria with code 0 (for sound), 1-3 (for enamel caries) and 4-6 (for dentine caries). ICDAS is an internationally applied system for caries detection used clinically (The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries (reference). Radiographic examination of the proximal surfaces of premolars and molars with one bitewing radiograph on each side of the mouth took place in the same session.
- Conditions
- Caries,Dental
- Being tested
- sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13), Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk.
- Keywords
- adolescents, flouridated milk, caries prevention, enamel caries, bitewing radiography
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13)Dietary supplement
Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk.Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | The subjects in the intervention group received individually packaged daily doses of sodium fluoride solution in 0.5 ml sterile water to be added to 200 ml of milk Receives: Dietary Supplement: sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13) |
| Control group | Placebo comparator | Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk. Receives: Dietary Supplement: Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries development in enamel and dentine
caries increment measured as change/no change of DMFS (Decayed, Missing, Filled, Surfaces)
Measured: From enrollment to the end of intervention at 2 years
Secondary outcomes (2)
Caries lesion arrest
Number of caries lesions given the same ICDAS score at the visual examination of the smooth surfaces combined with number of caries lesions of the proximal surfaces given the same radiographic score at baseline and 2 years
Measured: From enrollment to the end of intervention at 2 years
Caries lesion progression
Number of caries lesions given a higher ICDAS score at the visual examination of the smooth tooth surfaces combined with number of caries lesions of the proximal surfaces given a higher radiographic score at 2 years compared to baseline
Measured: From enrollment to the end of intervention at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2012
- Primary completion30 May 2020
- Study completionJun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Caries,DentalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms; an intervention group receiving doses of fluoride in water to add to milk and a control group receiving water to add to milk
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunnel Svensater, Malmö University
- Investigators
- Gunnel Svensäter, Principal investigator, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684405
- Sponsor's protocol ID
- Malmö University
- Status last verified
- Oct 2024
- First submitted
- 11 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
PubMed 17518963Senneby A, Elfvin M, Stebring-Franzon C, Rohlin M. A novel classification system for assessment of approximal caries lesion progression in bitewing radiographs. Dentomaxillofac Radiol. 2016;45(5):20160039. doi: 10.1259/dmfr.20160039. Epub 2016 Apr 4.
PubMed 27043978Rohlin M, Neilands J, Davies JR, Isberg PE, Wickstrom C, Svensater G. Fluoridated milk is effective in prevention of enamel caries in adolescents: a randomised trial. Acta Odontol Scand. 2025 Dec 29;84:673-684. doi: 10.2340/aos.v84.45271.
PubMed 41460820
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoridated Milk is Effective in Prevention of Enamel Caries in Adolescents
- ClinicalTrials.gov ID
- NCT06684405
- Acronym / sponsor ID
- Malmö University
- Conditions
- Caries,Dental
- Keywords
- adolescents, flouridated milk, caries prevention, enamel caries, bitewing radiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- Jun 2023 (actual)
- First posted
- 12 Nov 2024 (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.
The goal of this trial is to investigate whether low daily doses of fluoridated milk, in addition to oral hygiene routines with fluoridated toothpaste, can prevent caries development in adolescents' teeth. The main questions it aims to answer are:
- Does fluoridated milk lower the number of caries lesions in teeth over time?
- Does fluoridated milk lower the number of enamel caries lesions over time? Researchers will compare an intervention group receiving doses of fluoride in water to add to milk and a control group receiving water to add to milk.
The 12-13 year participants will:
- be examined at a baseline and once yearly up to 2 years
- be provided directly with the doses every second month at their dental clinic
- take the fluid daily
Detailed description
During the study, the participants were asked to continue with their usual oral hygiene regimes, including tooth-brushing twice a day with toothpaste containing fluorides as recommended by the Swedish National Board of Health and Welfare.
At their yearly visit to their dental clinic the participants were asked about their health status, use of antibiotics, lactose intolerance, daily consumption of milk, tooth brushing frequency, type of toothpaste and use of other fluoride additives. Information on adverse effects (dental pain, visit to other dental clinic, and antibiotics due to dental infection) was collected.
Caries registration was performed by visual-tactile and radiographic examinations at baseline and 1 and 2 years. Visual-tactile examination was performed by a dental practitioner under lighting with a mirror and occasionally with a probe. Caries status was classified for the occlusal/incisal, buccal and lingual surfaces and the proximal surfaces of incisors and cuspids according to the ICDAS criteria with code 0 (for sound), 1-3 (for enamel caries) and 4-6 (for dentine caries). ICDAS is an internationally applied system for caries detection used clinically (The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries (reference). Radiographic examination of the proximal surfaces of premolars and molars with one bitewing radiograph on each side of the mouth took place in the same session.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms; an intervention group receiving doses of fluoride in water to add to milk and a control group receiving water to add to milk
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13)The subjects in the intervention group received individually packaged daily doses of sodium fluoride solution in 0.5 ml sterile water to be added to 200 ml of milk |
| Control group | Placebo comparator | Dietary Supplement: Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk.Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk. |
Who may qualify
- Ages
- 12 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- adolescents of both sexes, aged 12-¬13
- healthy (no oral disease or systemic disease possibly affecting the oral cavity). Health declaration used in the dental clinic was utilized to confirm health status
- adolescents with permanent posterior teeth/no primary molar teeth present and second premolars in contact with the mesial surface of the first molars
- adolescents who, together with their parents or guardians, gave informed written consent to participate. Data confidentiality and the right to withdraw from the study at any time were warranted to the adolescents in writing.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13) | Dietary supplement | Intervention |
| Subjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk. | Dietary supplement | Control group |
Primary outcome
Caries development in enamel and dentine
Time frame: From enrollment to the end of intervention at 2 years
caries increment measured as change/no change of DMFS (Decayed, Missing, Filled, Surfaces)
2 secondary outcomes
Caries lesion arrest
Time frame: From enrollment to the end of intervention at 2 years
Caries lesion progression
Time frame: From enrollment to the end of intervention at 2 years
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 22 Nov 2024.
- Background: PubMed 17518963Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
- Background: PubMed 27043978Senneby A, Elfvin M, Stebring-Franzon C, Rohlin M. A novel classification system for assessment of approximal caries lesion progression in bitewing radiographs. Dentomaxillofac Radiol. 2016;45(5):20160039. doi: 10.1259/dmfr.20160039. Epub 2016 Apr 4.
- Derived from this study: PubMed 41460820Rohlin M, Neilands J, Davies JR, Isberg PE, Wickstrom C, Svensater G. Fluoridated milk is effective in prevention of enamel caries in adolescents: a randomised trial. Acta Odontol Scand. 2025 Dec 29;84:673-684. doi: 10.2340/aos.v84.45271.
- Individual participant dataSharing planned: No
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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.
Gunnel Svensäter principal investigator
Malmö University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13) in people with Caries,Dental, run by Malmö University at 1 site in Sweden.
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 4 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: finished, as of the sponsor's last update on 22 Nov 2024. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
Caries development in enamel and dentine (time frame: From enrollment to the end of intervention at 2 years). 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 NCT06684405, which also lists 3 linked publications.
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 22 Nov 2024.