Preventive Therapy of White Spot Lesions Using Different Remineralizing Agents in Children From 3 to 12 Years Old

Universitat Internacional de Catalunya

Status: Completed

Conditions: White Spot Lesion

Treatments: Other: FLUORINE VARNISH

Study type: Interventional

Funder types: Other

Identifiers

NCT04705428

UIC-ODP-WHITE SPOT

Details and patient eligibility

About

Compare by clinical observation, photographs and fluorescence the efficacy of sodium fluoride, silanofluoride and thiefenfluoride in treating white spots.

Full description

This in vivo study will be a randomized experimental clinical trial to be carried out in the Department of Pediatric Dentistry of the International University of Catalonia. Patients between the ages of 3 and 12, who attend the dental university clinic of the International University of Catalonia, will be part of the study.

Parents or legal guardians will be informed of the treatment procedure with a patient information sheet and informed consent will be given. Once signed, the patient will be assigned to one of the 3 study groups.

Accepting an alpha risk of 5% and with a power of 80% in a bilateral contrast, 15 subjects in each group are required to detect a minimum difference of 4 points between two groups, assuming that there are 3 groups and a standard deviation of 4.9. a follow- up loss rate of 10% has been estimated. The total number of children will be 45 by 15 for each group.

In order to analyze the degree of agreement of one examiner, 15 children will be evaluated twice, with a separation of one month.

Enrollment: 75 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients born between 2008 and 2017 of both sexes
• Patients with the active white spot lesions on vesicular and buccal surfaces of the incisors and molars of different sizes and with or without sensitivity to external stimuli
• Patients with white spot lesions that correspond to codifications of 0 to 2 of the ICDAS criteria.

Exclusion criteria

• Patients with mental disabilities or systemic diseases
• Patients with previously restored teeth
• Patients with clinical symptoms of irreversible pulpitis, allergy to fluoride and copper

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

75 participants in 3 patient groups

Group I: intervention group 1

Experimental group

Description:

Professional hygiene will be carried out with the application of fluoride varnish (Duraphat) and the use of fluoride paste according to the age will be recommended for oral hygiene at home.

Treatment:

Other: FLUORINE VARNISH

Group II: intervention group 2

Experimental group

Description:

Professional hygiene will be carried out with the application of fluorine varnish (Tiefenfluoride) and the use of fluoride paste according to the age will be recommended for oral hygiene at home.

Treatment:

Other: FLUORINE VARNISH

Group III: intervention group 3

Experimental group

Description:

Professional hygiene will be carried out with the application of fluorine varnish (Fluor Protector S) and the use of fluoride paste according to the age will be recommended for oral hygiene at home.

Treatment:

Other: FLUORINE VARNISH