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Comparison of toothpaste containing fluoride associated or not with arginine in initial caries lesions in milk teeth

Comparison of the remineralization potential of the dentifrice containing 1,450 ppm sodium monofluorophosphate associated or not with 1.5% arginine in white spot lesions in primary teeth: randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2g9vbx
Enrollment
Unknown
Registered
2017-11-07
Start date
2017-08-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Dental caries, Dental caries susceptibility, Tooth demineralization

Interventions

In this investigation, a minimum sample size of 52 active white spot lesions (ICDAS 2) on smooth surface of maxillary anterior primary teeth will be evaluated. Those lesions will be randomly divided i
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Sponsors

Universidade Cruzeiro do Sul
Collaborator
Universidade Cruzeiro do Sul
Lead Sponsor

Eligibility

Age
4 Years to 5 Years

Inclusion criteria

Inclusion criteria: Healthy children; aged 4 and 5 years old; both genders; resident in the city of São Paulo (public water fluoridation); present at least one visible active white spot lesion on smooth surface of maxillary anterior primary teeth (ICDAS 2); present signed Parent-Guardian Informed Consent Statement

Exclusion criteria

Exclusion criteria: Children who participated of previous research over the past 3 months; using orthodontic devices; with cognitive impairment or syndromes; using medication; receiving dental treatment with professional topical fluoride application (varnish, gel or mousse); children who not allow clinical examination

Design outcomes

Primary

MeasureTime frame
Primary outcome: Area of the white spot lesion verified by standardized digital photographic method from the observation of a variation in mm2 during measurements performed at baseline and after 3 months of the intervention. Progression, regression or stability of the area of the white spot lesion will be evaluated after 3 months of the intervention.

Secondary

MeasureTime frame
Secondary outcome: Reduction of the fluorescence values of the white spot lesion verified by a laser fluorescence device (DIAGNOdent pen) from the observation of a variation in number (from 0 to 99) during measurements performed at baseline and after 3 months of the intervention.;Secondary outcome: Evaluation of caries activity (active or inactive) of white spot lesion verified by visual inspection from the observation of an optical (opacity or brightness) and tactile (roughness or smoothness) variation during assessments performed after 3 months of the intervention.;Secondary outcome: Evaluation of global caries experience of the children assessed by dmft index at baseline and after 3 months of the intervention.

Countries

Brazil

Contacts

Public ContactMichele Diniz

Universidade Cruzeiro do Sul

mibdiniz@hotmail.com+55 11 98285-6909

Outcome results

None listed

Source: REBEC (via WHO ICTRP)