Comparison of the Effect of Fluoride Remineralizer Gel and Foam

NCT02490592 | Completed Phase 4 DMC

• 1 other identifier: CAAE: 25687413.8.000.5176
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

Compare the remineralizing effect of acidulated fluoride gel Flugel (1.23% FFA, DFL) and acidulated Fluoride Foam Flúor Care (1.23% FFA, FGM) in maxillary anterior permanent teeth of 58 children aged 7 to 12 years of age. to verified the activity (visual scores) and the dimensional changes of whit spot lesions (with WHO probe and millimeter ruler), risk for caries (CAMBRA) and OHI-S (Simplified Oral Hygiene Index) of children.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (2)

• visual scores

  activity changes of whit spot lesions

  within the first 60 days

• millimeters (with WHO probe and millimeter ruler)

  dimensional changes of whit spot lesions

  within the first 60 days

Study Arms (2)

G1

EXPERIMENTAL

Thirty children aged seven to twelve years who had seventy one active white spots lesions in permanent anterior teeth randomly assigned to four or eight weekly intervals applications of fluoride foam, Flúor Care (NaF 1.23%), to verified the activity (visual scores) and the dimensional changes of whit spot lesions (with WHO probe and millimeter ruler), caries Management by Risk Assessment (CAMBRA) and OHI-S (Simplified Oral Hygiene Index) of children.

Other: Fluoride Foam

G2

EXPERIMENTAL

Twenty-eight children aged seven to twelve years who had seventy five active white spots lesions in permanent anterior teeth randomly assigned to four or eight weekly intervals applications of fluoride gel, Flugel FFA (NaF 1.23%), to verified the activity (visual scores) and the dimensional changes of whit spot lesions (with WHO probe and millimeter ruler), caries Management by Risk Assessment (CAMBRA) and OHI-S (Simplified Oral Hygiene Index) of children.

Other: Fluoride gel

Interventions

Fluoride Foam OTHER

Fluoride foam - Flúor Care (NaF 1.23%) (G1)

G1

Fluoride gel OTHER

Fluoride gel - Flugel FFA (NaF 1.23%) (G2)

G2

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child with active incipient caries lesions (white spots) on upper anterior permanent teeth; permission from parents / guardians through the consent form, authorization of the minor through the term of assent, children at high risk for dental caries.

You may not qualify if:

• Children who used braces, medications that alter the flow / salivary composition or antibiotics in the month before the exam. Not patients with syndromes or changes in tooth development, patients with cognitive and motor disorders were included.

Sponsors & Collaborators

• University Center of João Pessoa: lead
• Universidade Cruzeiro do Sul: collaborator

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Jainara Ferreira, Phd

  UNIPÊ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: JAINARA MARIA SOARES FERREIRA

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: July 7, 2015
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 7, 2015

Record last verified: 2015-07