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Study of the efficacy of calcium and phosphate containing fluoride paste and a placebo paste to promote remineralisation of caries developed during orthodontic treatment with fixed appliances.

Study of the efficacy of calcium and phosphate containing fluoride paste and a placebo paste to promote remineralisation of caries developed during orthodontic treatment with fixed appliances. - remineralization of caries developed during orthodontic treatment.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30955
Enrollment
50
Registered
2008-03-19
Start date
2007-11-15
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

caries caries tooth decay

Interventions

Participants with caries on the buccal surfaces upon removal of the fixed appliances will be put on a rigid oral hygiene program. One-half of subjects will also receive a a paste containing Casein P

Sponsors

Academisch centrum voor tandheelkunde
Lead Sponsor

Eligibility

Age
12 Years to 17 Years

Inclusion criteria

Inclusion criteria: Subject is enrolled as patient at the orthodontic clinic of ACTA, and receives orthodontic treatment with fixed appliances and is scheduled for debracketing. Subject is between 12 and 18 years old at the start of the study. Subject, and also a parent or guardian, have signed the informed consent form prior to the start of the study. Subjects have at least two detectable caries lesions on their buccal surfaces immediately after debracketing.

Exclusion criteria

Exclusion criteria: Subject is younger than 12 years old or older than 18 years old. Subject is mentally not capable to understand and follow instructions. Subject suffers from a systemic illness. Subject is milk protein intolerant, because this may provoke an allergic reaction to the CPP-ACP paste. Subject has caries lesions that need restorative care.

Design outcomes

Primary

MeasureTime frame
Number of Caries lesions, change in lesion extent expressed by their fluorescence loss and lesion area over a one-year study period.

Secondary

MeasureTime frame
Plaque composition and acidogenicity

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)