Clinical trial NCT06684405: Fluoridated Milk and Enamel Caries in Adolescents
Official title: Fluoridated Milk is Effective in Prevention of Enamel Caries in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries,Dental
Keywords: adolescents
flouridated milk
caries prevention
enamel caries
bitewing radiography
Lead sponsor: Malmö University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 159
Sex: ALL
Minimum age (years): 12
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caries development in enamel and dentine
timeFrame: From enrollment to the end of intervention at 2 years
Secondary outcomes:
measure: Caries lesion arrest
timeFrame: From enrollment to the end of intervention at 2 years
measure: Caries lesion progression
timeFrame: From enrollment to the end of intervention at 2 years
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Faculty of Odontology, Malmo University
Study officials:
affiliation: Malmö University
name: Gunnel Svensäter
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.