Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT06684405
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.
Study:
NCT06684405
Study Brief:
Protocol Section:
NCT06684405