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

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ClinicalTrials.gov Identifier: NCT04705428
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Francisco Guinot-Jimeno, Universitat Internacional de Catalunya

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

Condition or disease Intervention/treatment Phase
White Spot Lesion Other: FLUORINE VARNISH Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventive Therapy of White Spot Lesions Using Different Remineralizing Agents in Children From 3 to 12 Years Old
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Other: 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.

Other Names:
  • 3 MONTHS
  • 6 MONTHS
Experimental: 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.
 Other: 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.

Other Names:
  • 3 MONTHS
  • 6 MONTHS
Experimental: 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.
 Other: 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.

Other Names:
  • 3 MONTHS
  • 6 MONTHS


Outcome Measures
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Primary Outcome Measures :
  1. visual examination, [ Time Frame: 6 MONTHS ]
    Clinical examination, using ICDAS criteria for the visual diagnosis of caries. The visual inspection will be carried out using the ICDAS criteria. Selected sites will be examined with direct visualization under light illumination and a three-in-one air syringe, without probing. Wet teeth will be evaluated first, and then dried after 5 s. Visual examination will be coded as follows: (0) healthy tooth surfaces, with no evidence of caries after prolonged air drying (5 s); (1) white or brown stain visible on dry enamel; (2) white or brown stain visible on wet enamel. Teeth with codes from 0 to 2 will be included in the study.

  2. tactile examination [ Time Frame: 6 MONTHS ]
    Tactile examination. An exploratory probe will be used by moving it over the examination surfaces without applying pressure. The data will be recorded as follows: 1. Smooth surface, 2 Rough surface, based on a modification of the criteria of Ekstrand et al.

  3. fluorescence [ Time Frame: 6 MONTHS ]
    Using the quantitative light fluorescence method using a VistaProof device (Dürr Dental), the use of which significantly improves the quality of the diagnoses. The results will be evaluated by recording the indications of fluorescence intensity before and after treatment. The fluorescence chamber will be positioned up, parallel to the buccal / buccal surface. The software (DBSWIN, Dürr Dental) will digitize the video signal to create buccal / buccal surface images of 720 × 576 pixels with 3 × 8 bit RGB channel intensities and a resolution of 72 pixels / inch14,15. This software will quantify the fluorescence emitted from green (wavelength of approximately 510 nm) to red (wavelength of approximately 680 nm), and will assign a numerical value of 0 to 3, which corresponds to the severity of the injury according to the manufacturer's instructions.

  4. photography [ Time Frame: 6 MONTHS ]
    Photography. To standardize photographic conditions, the camera will always be placed at the same distance from the tooth surface. To exclude the influence of moisture on the tooth color, the tooth surfaces will be dried with compressed air for 30s. Clinical photographs will be taken with a digital camera (EOS 5d Mark II camera; Canon, Tokyo, Japan), macro lenses (SP AF100 mm F ⁄ 2.8 Di 1: 1 Macro lenses; Canon, Tokyo, Japan) and flash (MT Twinlight 24- EX; Canon). The camera settings will be as follows: shutter speed 1 ⁄ 125, F29, ISO 200 and automatic white balance. The photographic evaluation will be carried out by the same examiner; Photographs will be randomly designated to avoid measurement bias and will be measured using the L * a * b * scoring method of the Commission Internationale de l'E 'clairage.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705428


Contacts
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Contact: Francisco Guinot Jimeno, DDS, MsC 0034 93 504 50 00 fguinot79@hotmail.com
Contact: ANA VELOSO DURAN, DDS, MsC 0034 93 504 50 00 ana_veloso13@hotmail.com

Locations
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Spain
Universitat Internacional de Catalunya Recruiting
Sant Cugat del Vallès, Barcelona, Spain, 08195
Contact: Francisco Guinot Jimeno, DDS, MsC    0034 93 5045000    fguinot79@hotmail.com   
Principal Investigator: Francisco Guinot Jimeno, DDS, MsC         
Principal Investigator: ANA VELOSO DURAN, DDS, MsC         
Sponsors and Collaborators
Universitat Internacional de Catalunya
More Information
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Responsible Party: Francisco Guinot-Jimeno, Jefe departamento de odontopedaitria, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier: NCT04705428    
Other Study ID Numbers: UIC-ODP-WHITE SPOT
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs