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Effect and acceptance of a substance that causes early-stage caries of permanent molars to stop developing compared to a treatment with fluoride varnish.

Efficacy and acceptability in the use of cariostatic compared to fluoride varnish in caries lesions in enamel in first permanent molars.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-2z4fkw
Enrollment
Unknown
Registered
2019-04-08
Start date
2018-09-06
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.

Interventions

SDF Group: Number of participants: 40 patients. 1. Use prophylactic paste without fluoride, clean the tooth / teeth to be treated
2. Isolate the area to be treated with cotton rollers
3. Dry the teeth to be treated and adjacent gingival tissues. 4. Apply a small amount of the gingival protection barrier to the tissues that are slightly overlying the tooth (<1 mm) and in the interpr
Drug

Sponsors

Universidade de Brasilia
Lead Sponsor
Universidade de Brasilia
Collaborator

Eligibility

Age
6 Years to 11 Years

Inclusion criteria

Inclusion criteria: Children who present at least one active initial carious lesion (Score 1 and 2 of ICDAS II + LAA); Detected by visual and tactile examination on occlusal surfaces of first permanent molars at different stages of eruption, will be included in the study.

Exclusion criteria

Exclusion criteria: Absence of first permanent molars; Permanent permanent molars, restored or with carious cavity in enamel or dentin; Children with systemic impairment and / or special needs; Children who have other dental treatment needs will be referred to try vacancies specializing in Pediatric Dentistry and the Pediatric Dentistry Clinic of UnB; In addition, all individuals will receive oral hygiene guidelines and eating habits.

Design outcomes

Primary

MeasureTime frame
It is expected to find a preventive fraction of 48% after a period of 24 months of control and follow-up with the use of diamino fluoride silver compared to fluoride varnish. This will calculate the proportion (percentage) of caries lesions that become inactive (paralyze) in the test group, compared to the control group. Revisions will be made after 3, 6, 12 months. A preventive fraction of 52% is still expected for the application of 38% silver fluoride diamine. Thus, a clinically significant difference is expected to be 20% in the rate of preventive fraction between groups.

Secondary

MeasureTime frame
Information about aesthetic perception will be obtained through the questionnaire Child's and Parent's Questionnaire about Teeth Appearance, applied to those responsible in the final consultation. Thus, it will be evaluated if there was a change in the aesthetic perception from the viewpoint of the responsible, comparing the results after the treatment. Thus, we will evaluate if there was a change in the quality of life of the child and the family, comparing the results after the treatment.

Countries

Brazil

Contacts

Public ContactRafaela Andrade

Universidade de Brasilia

rafaelasabino@gmail.com+5561992151045

Outcome results

None listed

Source: REBEC (via WHO ICTRP)