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White Spot LesionNCT04705428

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

A study testing FLUORINE VARNISH in people with White Spot Lesion, run by Universitat Internacional de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 3 to 12 yearsHealthy volunteers can take part
Conditions the study is for
White Spot Lesion
What is being tested?
FLUORINE VARNISH
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSpain
Study dates
1 Jan 2021to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Spain1 site

  • Universitat Internacional de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195

Other trials in Spain

About this study

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

Read the 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.

Being tested
FLUORINE VARNISH

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FLUORINE VARNISHOther

    Also called 3 MONTHS, 6 MONTHS

    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.

Study groups in NCT04705428
Study groupRoleWhat they receive
Group I: intervention group 1ExperimentalProfessional 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.
Receives: Other: FLUORINE VARNISH
Group II: intervention group 2ExperimentalProfessional 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.
Receives: Other: FLUORINE VARNISH
Group III: intervention group 3ExperimentalProfessional 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.
Receives: Other: FLUORINE VARNISH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. visual examination,

    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.

    Measured: 6 MONTHS

  2. tactile examination

    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.

    Measured: 6 MONTHS

  3. fluorescence

    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.

    Measured: 6 MONTHS

  4. photography

    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.

    Measured: 6 MONTHS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2021
  2. Study start1 Jan 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04705428
Sponsor's protocol ID
UIC-ODP-WHITE SPOT
Status last verified
May 2023
First submitted
8 Jan 2021
Last updated
25 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing FLUORINE VARNISH in people with White Spot Lesion, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

visual examination, (time frame: 6 MONTHS). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04705428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.

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