Caries,Dental
Conditions
Keywords
adolescents, flouridated milk, caries prevention, enamel caries, bitewing radiography
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTsodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13)
DIETARY_SUPPLEMENTSubjects in the control group received a daily dose of 0.5 ml sterile water to be added to 200 ml of milk.
Sponsors
Malmö University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
12 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caries development in enamel and dentine | From enrollment to the end of intervention at 2 years | caries increment measured as change/no change of DMFS (Decayed, Missing, Filled, Surfaces) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caries lesion arrest | From enrollment to the end of intervention at 2 years | 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 |
| Caries lesion progression | From enrollment to the end of intervention at 2 years | 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 |
Countries
Sweden
Outcome results
None listed