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Potential for Dentine Discoloration of Silver Diamino Fluoride Associated With Potassium Iodide

NCT04001959 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-07-05

No results posted yet for this study

Summary

The objective of this randomized clinical trial will be the comparison of dentine discoloration after treatment with: Silver Diamino Fluoride and Silver Diamino Fluoride associated with Potassium Iodide for caries lesions in posterior primary teeth. The study sample will consist of children presenting caries lesion in dentin, without reporting spontaneous pain. The children will be allocated into 2 groups that will correspond to the treatments with the use of SDF (Group 1), SDF + PI (Group 2). Treatment will be performed by trained and calibrated researchers. Examiners will be blind to the treatment received. Initially, data will be collected on socio-demographic aspects, characteristics of children, and clinical aspects. Clinical, photographic and initial evaluations will be performed after 1 week, 15 days, 1 and 2 months after treatment. The results obtained will be typed and organized in a database, using the software Statistical Package for Social Science (SPSS), version 22.0 and descriptive, bivariate analyzes will be performed.

Conditions

  • Dental Caries in Children

Interventions

PROCEDURE

Silver Diamine Fluoride with Potassium Iodide

Dry the tooth for 30 seconds with air jet and apply one drop of Diamino 30% Silver Fluoride with a disposable applicator brush for 3 minutes and one drop of potassium iodide solution immediately on the treated surface, then wash.

Sponsors & Collaborators

  • Federal University of the Valleys of Jequitinhonha and Mucuri

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2019-07-31
Completion
2019-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04001959 on ClinicalTrials.gov