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

NCT ID: NCT04705428

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-06-30

Brief Summary

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

Detailed 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.

Conditions

White Spot Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group I: intervention group 1

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.

Group Type: EXPERIMENTAL

FLUORINE VARNISH

Intervention Type: OTHER

Participants in all groups will receive written oral hygiene and oral prophylaxis instructions. All groups will receive the application of fluorine varnish every 3 months.

The application of fluoride in the three groups will be done as follows:

-Drying of the teeth, placement of the fluorine varnish on the teeth by quadrants. The varnish will be left to dry for a few seconds according to the manufacturer's instructions. Children in all groups will be asked to avoid brushing and flossing for one day after applying fluoride. They will be instructed to avoid hard food and hot drinks for 4 hours. Children and parents will be instructed on how to care for their teeth at home: brush teeth with conventional toothpaste containing 1000 ppm sodium fluoride, for 3 minutes without rinsing.

In the following reviews (3 and 6 months) the effectiveness of the treatments will be evaluated by visual examination, tactile examination, fluorescence and photography.

Group II: intervention group 2

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.

Group Type: EXPERIMENTAL

FLUORINE VARNISH

Intervention Type: OTHER

Participants in all groups will receive written oral hygiene and oral prophylaxis instructions. All groups will receive the application of fluorine varnish every 3 months.

The application of fluoride in the three groups will be done as follows:

-Drying of the teeth, placement of the fluorine varnish on the teeth by quadrants. The varnish will be left to dry for a few seconds according to the manufacturer's instructions. Children in all groups will be asked to avoid brushing and flossing for one day after applying fluoride. They will be instructed to avoid hard food and hot drinks for 4 hours. Children and parents will be instructed on how to care for their teeth at home: brush teeth with conventional toothpaste containing 1000 ppm sodium fluoride, for 3 minutes without rinsing.

In the following reviews (3 and 6 months) the effectiveness of the treatments will be evaluated by visual examination, tactile examination, fluorescence and photography.

Group III: intervention group 3

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.

Group Type: EXPERIMENTAL

FLUORINE VARNISH

Intervention Type: OTHER

Participants in all groups will receive written oral hygiene and oral prophylaxis instructions. All groups will receive the application of fluorine varnish every 3 months.

The application of fluoride in the three groups will be done as follows:

-Drying of the teeth, placement of the fluorine varnish on the teeth by quadrants. The varnish will be left to dry for a few seconds according to the manufacturer's instructions. Children in all groups will be asked to avoid brushing and flossing for one day after applying fluoride. They will be instructed to avoid hard food and hot drinks for 4 hours. Children and parents will be instructed on how to care for their teeth at home: brush teeth with conventional toothpaste containing 1000 ppm sodium fluoride, for 3 minutes without rinsing.

In the following reviews (3 and 6 months) the effectiveness of the treatments will be evaluated by visual examination, tactile examination, fluorescence and photography.

Interventions

FLUORINE VARNISH

Participants in all groups will receive written oral hygiene and oral prophylaxis instructions. All groups will receive the application of fluorine varnish every 3 months.

The application of fluoride in the three groups will be done as follows:

-Drying of the teeth, placement of the fluorine varnish on the teeth by quadrants. The varnish will be left to dry for a few seconds according to the manufacturer's instructions. Children in all groups will be asked to avoid brushing and flossing for one day after applying fluoride. They will be instructed to avoid hard food and hot drinks for 4 hours. Children and parents will be instructed on how to care for their teeth at home: brush teeth with conventional toothpaste containing 1000 ppm sodium fluoride, for 3 minutes without rinsing.

In the following reviews (3 and 6 months) the effectiveness of the treatments will be evaluated by visual examination, tactile examination, fluorescence and photography.

Intervention Type: OTHER

Other Intervention Names

3 MONTHS; 6 MONTHS

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Francisco Guinot-Jimeno

Jefe departamento de odontopedaitria

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Countries

Spain

Other Identifiers

UIC-ODP-WHITE SPOT

Identifier Type: -

Identifier Source: org_study_id