Fluoridated Milk and Enamel Caries in Adolescents

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.

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

Study Overview

• Status: Completed
• Conditions: Caries,Dental
• Intervention / Treatment: Dietary supplement: 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.

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 Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmo, Sweden
    • Faculty of Odontology, Malmo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; 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	Dietary supplement: sodium sodium fluoride solution (0.75 mg for subjects aged 12 and 1.0 mg for subjects aged 13)
Placebo Comparator: Control group; 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: 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 the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Malmö University
• Investigators: Principal Investigator: Gunnel Svensäter, Malmö University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: adolescents; caries prevention; flouridated milk; enamel caries; bitewing radiography
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries; Anti-Infective Agents; Physiological Effects of Drugs; Protective Agents; Anti-Infective Agents, Local; Cariostatic Agents; Fluorides; Listerine; Sodium Fluoride
• Other Study ID Numbers: Malmö University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No