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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:
The 12-13 year participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13) | Dietary Supplement |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Caries development in enamel and dentine | caries increment measured as change/no change of DMFS (Decayed, Missing, Filled, Surfaces) | From enrollment to the end of intervention at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of intervention at 2 years |
| Caries lesion progression |
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Inclusion Criteria:
Exclusion Criteria:
None
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| Name | Affiliation | Role |
|---|---|---|
| Gunnel Svensäter | Malmö University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Odontology, Malmo University | Malmö | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17518963 | Background | 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. | |
| 27043978 | Background | Senneby 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. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008892 | Milk |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
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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
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The subjects and their parents/guardians, the clinicians performing the examinations, the staff-members delivering the packages with solutions to the subjects, the trial investigators and the outcome assessors were blind to the allocation and group assignment. The solutions were distributed to the subjects in tubes pre-labelled with code numbers. The tubes had the same design independent of the solution with fluoride or placebo.
After the randomization, lists with code numbers were saved as sealed files in a safety-deposit box. The code was broken when the study was completed, and the assessment of the outcome measures were processed.
| 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 |
|
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 |
| From enrollment to the end of intervention at 2 years |
| 41460820 | Derived | Rohlin 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. |
| D005502 |
| Food |
| D019602 | Food and Beverages |