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Comparison between Sodium Fluoride Varnish and Titanium Tetrafluoride Varnish to prevent White Spots in Orthodontics

Prevention and Remineralization of White Spot Lesions in Orthodontics: comparison of the efficacy of Sodium Fluoride Varnish and Titanium Tetrafluoride (TiF4) Varnish

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-104n8kqh
Enrollment
Unknown
Registered
2021-07-14
Start date
2019-04-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries limited to enamel

Interventions

This study investigated the effectiveness of fluoride varnishes in preventing and remineralizing white spot lesions (WSLs) and their impact on the oral microbiome in orthodontic patients. To compare t

Sponsors

Faculdade de Odontologia de Bauru - Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia de Bauru - Universidade de São Paulo
Collaborator

Eligibility

Age
11 Years to 18 Years

Inclusion criteria

Inclusion criteria: Age between 11-18 years; both sexes; complete permanent dentition; having at least one active white spot lesion on the smooth surfaces of the permanent dentition (Nyvad index score 1); being under orthodontic treatment with a fixed appliance initiated between 6-18 months

Exclusion criteria

Exclusion criteria: Patients with cavitated caries lesions; who have undergone topical fluoride application in the past 6 months

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: After professional prophylaxis, the analysis of the vestibular surfaces and around the brackets will be made using the Nyvad index, which will be the primary outcome, clinical evolution or not of the white spot lesion. In this index we will define the activity of the white spot lesion, being considered active (lesion progression) when the active white spot lesion - initial non-cavitated (score 1) turns into cavitated enamel (score 3) or when a healthy surface (score 0) turns into an active white spot lesion - not cavitated (score 1) or cavitated (score 3). The regression will be considered when the active white spot lesion - initial cavitation (score 1) turns into inactive caries lesion - non-cavitated (score 2) or healthy surface (score 0). The appearance of new lesions will be considered when a healthy tooth becomes an active white spot lesion (score 1). In summary, the participants will be considered caries-inactive, when they have no cavities and no active cavities lesion. Volunteers who present cavities or cavities with active caries will be considered caries-active;Expected outcome 2: In addition, the ICDAS index (International Caries Detection and Assessment System) will be applied in T0, T1 (6 months), T2 (12 months), T3 (18 months) and T4 (24 months). ICDAS is an international caries detection and evaluation system that classifies the stages of the caries process. In this ICDAS index, we will define the progression or regression of the white spot lesion. The progression of the white spot lesion will be considered when the visible white spot lesion after drying (score 1) turns into visible white spot lesion in moisture (score 2) or localized cavitation (score 3). Or the progression will be when score 2 turns to 3. Regression will be considered when the visible white spot lesion in moisture (score 2) turns into score 1 or when score 1 turns into score 0. The appearance of new injuries will be considered when a healthy tooth becomes a white

Secondary

MeasureTime frame
Expected outocome 3: Two parameters will be measured by examining the surfaces by QLF (equipment applied to measure changes in enamel fluorescence of white spot lesions and to quantify the reversion or progression of lesions), lesion area (mm2) and change in fluorescence (delta F,%). For the storage and analysis of images, the QLF 2.00f software (Inspektor Research System BV) will be used. Thus, the lesion area (mm2), the loss of fluorescence in% (the detection threshold is 5%) and the loss of integrated fluorescence (delta Q, mm2 *%) will be determined. The procedures will be repeated, using plugs in the same position as the initial lesions and the new white spot lesions, at the end of 6, 12, 18 and 24 months. The total evaluation will be carried out by subtracting the images and quantification will be done later by another examiner who is blind to the treatment group. The reproducibility of QLF image analysis will be accessed by calculating intra-examiner reliability (10% repetition of analyzes);Outcome found 3: Increase or decrease in the lesion area (mm2) of pre-existing lesions during the study. In group G1, the white spot lesions maintained a consistent size throughout the observation period. In contrast, in the fluoride varnish groups, a reduction in lesion size was observed after 6 months. In group G2, this reduction was maintained until the end of the follow-up, while in group G3, a new reduction was observed after 12 months that was maintained until T3. Over time, we could observe a statistically significant difference between the groups only after 12 and 18 months, in which group G3 presented a smaller white spot lesion area than groups G1 and G2 (p 5.0% in the biofilm samples. These include Prevotella, Corynebacterium, Veillonella, Fusobacterium, Leptotrichia, Capnocytophaga, and Streptococcus. In G2, this percentage increases to 66%, with predominant genera (>5.0%) such as Veillonella, Neisseria, Streptococcus, Prevotella, Corynebacterium, Haemophilus,

Countries

Brazil

Contacts

Public ContactSamanta Moraes

Faculdade de Odontologia de Bauru - Universidade de São Paulo

samantamoraes@usp.br+55-15-998020196

Outcome results

None listed

Source: REBEC (via WHO ICTRP)