RU2849125C1 - Method for determining the risk of enamel demineralisation in patients using braces - Google Patents

Abstract

FIELD: medicine; immunology; dentistry.

SUBSTANCE: invention can be used to determine the risk of enamel demineralisation in patients undergoing orthodontic treatment using fixed orthodontic appliances. The essence of the invention is that the method for determining the risk of enamel demineralisation in patients using fixed orthodontic appliances consists in determining the levels of M-CSF and sIgA, in pg/ml and g/l, in oral fluid from 8 a.m. to 9 a.m. one day before the installation of braces and M-CSF 10 days after the installation of braces, in pg/ml, calculating the ratio of M-CSF 10 days after braces installation to M-CSF 1 day before braces installation as a percentage, with a high risk determined at an M-CSF level of 1100 pg/ml or less in the oral fluid of patients 1 day before the installation of braces, followed by an increase in the M-CSF level on day 10 by 50% or less and an sIgA level in oral fluid of 0.5 g/l or less, medium risk is determined by an M-CSF level of 1100 pg/ml or less in the oral fluid of patients 1 day before the installation of braces, followed by an increase in the M-CSF level on the 10th day after the installation of braces by 50% or less and an sIgA level in the oral fluid of more than 0.5 g/l, Medium risk is also determined by an M-CSF level in oral fluid of 1100 pg/ml 1 day before the installation of braces, regardless of the sIgA level. and low risk is determined when the level of M-CSF in oral fluid 1 day before the installation of braces is less than 110 pg/ml, regardless of the dynamics of M-CSF on day 10 and the level of sIgA.

EFFECT: compared to known solutions, the claimed invention allows for more accurate calculation of the individual risk of enamel demineralisation in patients using fixed orthodontic appliances within 12 months after installation of the braces system by analysing changes in the level of M-CSF in oral fluid 1 day before and 10 days after installation of the braces system, as well as the level of sIgA in oral fluid 1 day before installation of the braces system, regardless of age.

1 cl

Description

The invention relates to the field of medicine, namely immunology and dentistry, and can be used to determine the risk of developing enamel demineralization in patients during orthodontic treatment using fixed orthodontic appliances (FOE).

The rapid introduction of braces into Russian orthodontics occurred twenty years ago and revolutionized the field: it made it possible to individually move teeth, providing control over their position. Other advantages of braces are undeniable: no discomfort or pain during treatment; the ability to correct anomalies in adult patients; and a minimal number of visits to the treating physician. However, not everything is as rosy as it seems at first glance. The device consists of special miniature metal devices—brackets—that are affixed directly to the vestibular surface of the teeth using adhesives [1]. Orthodontic treatment sometimes lasts for 2-3 years, and the braces, glued to the teeth for this entire period, become a mechanical obstacle to the natural self-cleaning of the oral cavity. One of the generally recognized dangers in orthodontic practice is enamel demineralization, which is detected during treatment and after the removal of the braces. This problem is extremely relevant not only for domestic orthodontics but also abroad. The overwhelming majority of orthodontic patients are adolescents, whose enamel has not yet fully formed. According to the literature, the oral hygiene status of adolescents with disocclusions, according to the OHY-S hygiene index, is 3.06 (very poor hygiene level) [2]. A lack of consistent oral hygiene skills is the basis for an increase in the amount of soft plaque around the bases of brackets, especially in the cervical areas and contact points. In addition to natural retention points for bacterial flora, many other points appear during orthodontic treatment with fixed appliances. It has been proven that the quantitative composition of the microbial flora also changes; it significantly increases in all patients with braces [3]. Long-term retention of microbial plaque in these patients leads to focal demineralization, as acid diffusion through the interprismatic spaces of the enamel and dissociation of calcium and phosphate in the surface layer begins. Clinically, this manifests as white spots and stripes that follow the contours of the bracket bases. Based on observations, molars, which serve as abutment teeth throughout the treatment period, are also susceptible to demineralization [4]. Particularly common problems arise between the band and the gingival margin in the cervical area, as this area of the tooth surface becomes difficult to access during brushing, and the accumulation of food debris and microbial plaque leads to demineralization.

Enamel demineralization is the loss of some of the enamel's mineral components. Since oral fluid is highly supersaturated with Ca2+ and ( _PO4 ) ₃ ions, natural fluctuations in their concentrations have little effect on the rate of demineralization and remineralization.

Thus, the concentration of hydroxyl ions has a decisive influence on the dissolution and crystallization of apatite. It has been established that when the pH decreases to 5.5 and below, the rate of hydroxyapatite demineralization significantly exceeds that of remineralization [5].

The main source of acids are microorganisms in dental plaque. Due to the presence of ion exchange, protons (hydronium ions) can be absorbed by enamel up to a certain limit without destroying its structure. Leontiev V.K. and Vershinina O.I. established that enamel demineralization in acidic environments in vitro occurs with a preferential release of Ca ²⁺ ions compared to PO ₄ ^3- ions, i.e., the dissolution process is accompanied by selective decalcification of enamel and suggested the parallel course of two reactions [6]:

Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ +8H ⁺ → 10Ca ²⁺ + 6HPO ^2- + 2H ₂ O (1),

Ca ₁₀ (PO ₄ ) ₆ (OH) ₂ + H ₃ O ⁺ ← Ca ₉ (H ₃ O) ₂ (PO ₄ ) ₆ (OH) ₂ + Ca ²⁺ (2).

Thus, enamel acts as a buffer system against acids acting on its surface. By displacing Ca2 ⁺ , _H3O ⁺ ions are bound by hydroxyapatite. While the hydroxyapatite structure is preserved, its ability to resist acid is reduced due to the reduced excess calcium. A drop in the calcium-phosphorus molar ratio below 1.30 indicates the destruction of the hydroxyapatite crystal lattice, the depletion of calcium reserves, and the inability of enamel to further resist dissolution.

Thus, the Ca/P ratio is an indicator of enamel resistance to acid attack. The degree of enamel demineralization is related to the size of the carious spot, as follows: the larger the spot, the more pronounced the loss of calcium and phosphorus. Demineralization in all layers of enamel progresses in the following sequence: light brown → brown → black carious spot. Demineralization in caries decreases from the enamel surface to the enamel-dentin junction.

In individuals undergoing orthodontic treatment, the prevalence and severity of underlying dental diseases is significantly higher than in individuals without orthodontic appliances [7]. After removal of braces, up to 55% of tooth surfaces exhibit demineralization, manifesting as white spots and stripes that follow the contours of the bracket bases. Molars, which serve as supporting teeth throughout orthodontic treatment, are also susceptible to demineralization [8].

It is believed that one of the most important pathogenetic factors in the development of caries is the condition of the hard tissues of the teeth and, directly, the acid resistance of the enamel [3], as well as the nature of food intake, namely, excessive consumption of easily digestible carbohydrates and plaque [8, 13]. Cariogenic microorganisms of the oral cavity, in the presence of low molecular weight carbohydrates, produce organic acids, the prolonged exposure of which on the enamel of the teeth leads to demineralization and the formation of structural changes of varying depth [9]. Signs of demineralization with the use of HOT are detected already 4 weeks after the start of treatment and extend to a depth of up to 100 μm. In 75% of patients, decalcification of tooth enamel develops [10].

The issue of oral hygiene in patients undergoing orthodontic treatment with fixed appliances has received much attention recently, since the presence of dentoalveolar anomalies and orthodontic appliances lead to a significant deterioration in the hygienic condition of the oral cavity [11, 13]. This is due to the deterioration of natural tooth cleaning due to difficult access to the vestibular, lingual and buccal surfaces on which the orthodontic appliances are fixed [12]. Most authors note that orthodontic appliances complicate individual hygiene measures, promote the deposition of soft plaque and the retention of food debris, while changing the microbiological status and increasing the total microbial mass [13].

The risk of demineralization during orthodontic treatment can be predicted using the method of determining the level of cytokines (IL-17, MCSF, M-CSF) and secretory immunoglobulin in the saliva of patients planning orthodontic treatment.

Secretory immunoglobulin A (sIgA) in saliva functions as a local immune defense and plays a key role in the homeostasis of the oral microbiota. Immunoglobulin A (IgA) antibodies are active against a variety of pathogens and prevent their penetration through the oral mucosa and into dental tissue.

Measuring secretory IgA in saliva can assess immune defenses both locally in the oral cavity and throughout the entire immune system. Elevated IgA levels may indicate a strong immune response to a pathogen, while decreased IgA levels indicate decreased mucosal immunity.

SIgA antibodies maintain the integrity of the oral and maxillofacial mucosa by limiting microbial adhesion to the epithelial and dental surfaces and neutralizing enzymes, toxins, and viruses, or by acting synergistically with other antibacterial factors such as lysozyme, lactoferrin, and salivary and mucus peroxidases. Secretory IgA can also prevent the penetration of various antigens into the oral mucosa.

Naturally occurring sIgA antibodies may play an important role in the homeostasis of resident oral microflora, as well as in the prevention of caries and periodontal, as well as maxillofacial diseases (actinomycosis, phlegmon, abscesses, etc.). These antibodies were identified against S. mutans, A. actinomysetemcomitans and Porphyromonas gingivalis, which were strongly associated with pathological processes in the oral cavity [14].

Understanding the role of cytokines in enamel demineralization during orthodontic treatment is important for the development of new methods for the prevention and treatment of this complication:

- Biomarker studies: Measuring salivary cytokine levels may be a tool for choosing an orthodontic treatment method.

- Identification of risk groups requiring additional methods for preventing enamel demineralization during the installation of braces.

- Drug development: Inhibition of proinflammatory cytokine activity may be a new approach to the prevention and treatment of demineralization.

- Modification of orthodontic appliances: Changes in the design of orthodontic appliances that reduce pressure on teeth and periodontal tissues may reduce cytokine levels and the risk of demineralization.

The claimed method is based on determining the level of M-CSF and sIgA cytokines in the oral fluid of patients planning orthodontic treatment.

M-CSF is a cytokine, a small protein involved in cellular signaling. The active form of the protein is found extracellularly as a disulfide-linked homodimer and is thought to be formed by proteolytic cleavage of membrane-bound precursors [15].

The obtained data demonstrated the significance of analyzing the dynamics of macrophage-colony-stimulating factor (M-CSF) in oral fluid in patients after the installation of braces. The specificity and sensitivity of the method were increased when analyzing the baseline sIgA level. Analysis of M-CSF concentrations alone in patients with braces did not have any predictive value for enamel demineralization.

The proposed option, including the analysis of the dynamics of M-CSF in oral fluid within a month after the installation of the brace system, together with the analysis of sIgA concentrations as predictors of the development of enamel demineralization within 12 months after the brace system with high specificity (92%) and sensitivity (87%), is announced for the first time.

When developing a method for predicting the risk of enamel demineralization within 12 months of orthodontic treatment (bracket installation), the degree of agreement between observed and predicted events over 12 months was assessed based on the dynamics of changes in the ratio of the indicators included in the method. During the prospective and retrospective stages of the study, the Kaplan-Meier curve was used to estimate the incidence of enamel demineralization in the observed group of patients undergoing orthodontic treatment, followed by comparison with the risk of enamel demineralization within 12 months calculated using the proposed method. Multivariate correlation analysis was used to demonstrate the pathogenetic independence of the presented marker in relation to the likelihood of enamel demineralization within 12 months in this group of patients.

It should be emphasized that there is currently no accepted unified scale for predicting the risk of developing enamel demineralization during orthodontic treatment using NOT.

Among the existing methods, the so-called TER test (enamel resistance test) is worth noting for determining the functional resistance of enamel. A 2 mm diameter drop of hydrochloric acid at a concentration of 1 mmol/L is applied to the buccal surface of a maxillary central incisor, cleaned of plaque and dried of saliva, 2 mm from the incisal edge along the central line. After 5 seconds, the drop is rinsed off, and the enamel is dried with a cotton swab. Then, a drop of 1% methylene blue solution is applied for 1 minute. The dye is then removed with a cotton swab. The etching site is stained from a barely noticeable blue to an intense blue. The color of the stained area is compared with a standard blue color chart. If the TER test results are up to 30%, the probability of caries is practically zero. If the result is between 30 and 60%, there is a moderate risk of caries, and the enamel resistance is low. If the data is over 60%, there is a high risk of developing caries and very low enamel resistance [15].

The disadvantage of this method is its excessive invasiveness, which disrupts the structural integrity of the enamel prisms and completely destroys the protective pellicle of the enamel of an intact tooth, which can lead to the appearance of a new retention point for microbial adhesion, as well as cause a local decrease in the caries resistance of the enamel.

A method for determining the condition of the enamel surface is known in the prior art. A measured drop of liquid is applied to the tooth surface. After the liquid-enamel interaction is established, the contact angle is measured, which is used to assess the enamel surface condition. To determine the hygienic condition of tooth enamel, the contact angle of an uncleaned enamel surface is measured. The enamel surface is cleaned, and the contact angle is measured again. The hygienic condition of the tooth enamel is assessed based on the change in the contact angle. To determine the initial stage of demineralization, several cleaned teeth are examined. A decrease in the contact angle on a tooth indicates the initial stage of demineralization on that tooth. To determine the functional resistance of dental hard tissues to caries, the contact angle is measured on a previously cleaned tooth. The tooth surface is then treated with a buffer solution with a pH of 2.0-5.8. The contact angle is measured. The degree of decrease in the contact angle is used to assess the tooth's resistance to caries. The method allows determining the condition of the tooth enamel surface by comparing the wetting angles of a dosed drop of liquid before and after exposure to the tooth enamel (RU 2484763, IPC A61B 5/00, published 20.06.2013).

The disadvantages of this method include the use of complex equipment to measure the contact angle, making it inaccessible to most researchers. The procedure is time-consuming due to the multi-stage preparation of teeth and measurements. Subjective errors in interpreting the results are possible, reducing the reliability of the diagnosis. This method identifies the actual demineralization, not the conditions that cause it.

A method for diagnosing enamel demineralization in permanent teeth is known. It determines the functional resistance of dental hard tissues to caries and diagnoses enamel demineralization in permanent teeth with braces based on the current passing through the hard tissues. The controlled points are selected on the vestibular surface of the tooth in the cervical area - point 1, near the cutting edge of the tooth - point 2 and lateral to the edge of the bracket - point 3. After a month, the initial stage of demineralization is diagnosed: for the teeth of the upper jaw with an average level of resistance at a current strength of point 1 from 0.05 to 0.07 μA, at point 2 - from 0.02 to 0.04 μA, at point 3 - from 0.02 to 0.04 μA, and with a low level of resistance at a current strength of point 1 - from 0.18 to 0.22 μA, at point 2 - from 0.071 to 0.089 μA, at point 3 - from 0.12 to 0.16 μA; for the lower jaw teeth with an average resistance level at a current strength of 0.113 to 0.127 μA at point 1, 0.047 to 0.053 μA at point 2, 0.065 to 0.12 μA at point 3, and with a low resistance level at a current strength of 0.17 to 0.25 μA at point 1, 0.1 to 0.12 μA at point 2, and 0.17 to 0.19 μA at point 3. The method provides the possibility of diagnosing the condition of hard tissues of a tooth with fixed orthodontic equipment installed on it by identifying preclinical manifestations of demineralization of hard tissues of a tooth, taking into account the functional resistance of hard tissues of teeth to the carious process (RU 2239357, IPC A61B 5/05, A61C 19/04, published 10.11.2004).

The disadvantages of this method include the long period required to monitor all necessary points—one month—making it labor-intensive. The use of electric current can be unpleasant for the patient and limits the frequency of use. The accuracy of the diagnosis depends on many factors, including the patient's individual physiological characteristics. This method does not allow for assessing the risk of enamel demineralization during the installation of braces.

The technical result consists in increasing the accuracy of calculating the individual risk of developing enamel demineralization in patients during orthodontic treatment using a NOT for 12 months after installing a bracket system by analyzing the change in the M-CSF level in the oral fluid 1 day before and 10 days after installing the bracket system, as well as the sIgA level in the oral fluid 1 day before installing the bracket system, regardless of age.

The essence of the invention is that the method for determining the risk of enamel demineralization in patients using fixed orthodontic equipment consists of determining the levels of M-CSF and sIgA, in pg/ml and g/l, in oral fluid from 8 a.m. to 9 a.m. 1 day before installing the bracket system and M-CSF 10 days after installing the bracket system, in pg/ml, calculating a coefficient reflecting the ratio of M-CSF on the 10th day after installing the bracket system to M-CSF 1 day before installing the bracket system in percent. In this case, a high risk is determined at an M-CSF level of 1100 pg/ml or less in the oral fluid of patients 1 day before the installation of the bracket system, followed by an increase in the M-CSF level on the 10th day by 50% or less and an sIgA level in the oral fluid of 0.5 g/l or less, an average risk is determined at an M-CSF level of 1100 pg/ml or less in the oral fluid of patients 1 day before the installation of the bracket system, followed by an increase in the M-CSF level on the 10th day after the installation of the bracket system by 50% or less and an sIgA level in the oral fluid of more than 0.5 g/l, an average risk is also determined at an M-CSF level in the oral fluid 1 day before the installation of the bracket system of 1100 pg/ml regardless of the sIgA level, and a low risk is determined at an M-CSF level in the oral fluid 1 day before the installation of the bracket system of less 110 pg/ml regardless of the dynamics of M-CSF on day 10 and the level of sIgA.

The table shows the risk of developing enamel demineralization in patients during 12 months of orthodontic treatment depending on the level of M-CSF and sIgA in the oral fluid.

The method for determining the risk of enamel demineralization in patients using fixed orthodontic appliances is as follows.

Oral fluid is collected between 8:00 AM and 9:00 AM on an empty stomach without prior use of oral hygiene products until the day before brace placement. Before collecting the oral fluid, rinse the mouth with distilled water for several minutes, then collect the oral fluid by passively flowing it for 15 minutes into graduated tubes. The collected oral fluid is centrifuged at 3000 rpm with a mixer for 15 minutes and cooled to 5°C. 300 µl of the supernatant is collected, placed in a tube, and frozen in a freezer at -80°C. Oral fluid samples for sIgA are thawed before M-CSF determination, which is performed according to the instructions for the ELISA kits. Total protein is determined using the Bradford assay, which normalizes CSF-1 levels to total salivary protein.

The table shows the levels of M-CSF and sIgA in the oral fluid of patients before and after 10 days of orthodontic treatment and the risk of developing enamel demineralization during 12 months of observation.

The feasibility and effectiveness of the claimed method are demonstrated by the examples presented below.

The proposed method was developed based on the results of a scientific study involving 141 patients undergoing orthodontic treatment. After twice-daily M-CSF measurements, one day before and 10 days after brace installation, and sIgA levels, monthly examinations were conducted, recording symptoms:

- chalky spots on the enamel;

- enamel hyperesthesia.

The main criterion for inclusion in the study (at the start of observation) is the patient's signing of informed consent in accordance with the requirements for conducting scientific research.

Criteria for exclusion of a patient from the study:

- age under 18 years;

- partial adentia (absence of more than 3 teeth);

- installed orthopedic structures (crowns);

- presence of implants;

- presence of osteoporosis.

During the study, 20 cases of enamel demineralization were recorded in 141 patients with installed braces during a 12-month observation period.

Using this method, 87 patients were predicted to have a low risk of developing enamel demineralization within 12 months after the installation of the braces system (0 cases during the observation period), 33 patients were found to have an average risk (demineralization developed in 5 people (15% of the total), a high risk was identified in 21 people, and in 71% of cases this hypothesis was confirmed by 15 cases of enamel demineralization. The sensitivity of the proposed method for determining high risk was 79%, and its specificity was 95%.

Example 1.

Patient V., 21 years old.

Complaints: incorrect positioning of teeth on the upper and lower jaws in the anterior region, aesthetic disturbances.

Extraoral examination. The face is oval, medium in size, and symmetrical. Visually, there is a deficit in the midface, with the lower third of the face enlarged. The gaze is direct. The nasolabial folds are pronounced, and the chin is smoothed. The lips meet along the Klein line without tension. The profile is slanted forward. The mouth opens freely, 3 cm. Mandibular movements are normal and painless.

Intraoral examination. The oral vestibule is 8 mm. The gingiva is pale pink, the interdental papillae are a regular triangular shape with pointed apices, the frenulum of the lower lip is of regular shape and size, and has a correct insertion site. The frenulum of the upper lip is enlarged in the mesiodistal dimension in the upper third and has a correct insertion site. Occlusion: the first permanent molars of the upper and lower jaws occlude mesiodistally according to Angle's class III, the canines occlude according to Angle's class III, the midlines of the upper and lower dental arches coincide with each other and the midplane of the face. The buccal cusps of the upper lateral teeth overlap and closely contact the buccal cusps of the lower lateral teeth. The upper incisors contact the lower incisors.

Caries intensity index (CII) = 0.

The Fedorov-Volodkina oral hygiene index is 1.2 (good).

RMA in Parma modification - 4%.

The TER test showed a low risk of enamel demineralization.

The staining intensity was 25%

According to the stated method, the risk is high (M-CSF level in oral fluid 1 day before brace installation is 1100 pg/ml), 10 days after brace installation it is 1500 pg/ml, and the sIgA level is 0.5 ng/ml. After 10 months of observation, despite high adherence to hygiene procedures, the following symptoms developed:

- chalky spots on the enamel (around the braces and on the contact surfaces of the incisors);

- enamel hyperesthesia.

The above symptoms confirm the effectiveness of the proposed method.

Example 2.

Patient K., 33 years old.

Complaints: irregular shape and size of teeth on the upper and lower jaws; absence of teeth on the upper and lower jaws.

Extraoral examination. The face is oval, medium-sized, and symmetrical. Visually, there is a deficit in the midface, with the lower third of the face enlarged. The gaze is direct. The nasolabial folds are pronounced, and the chin is smoothed. The lips close along the Klein line without tension. The profile is slanted forward. The mouth opens freely—4 cm. Mandibular movements are normal and painless.

Intraoral examination. The oral vestibule is 7 mm. The gingiva is pale pink, the interdental papillae are a regular triangular shape with pointed apices, the frenulum of the lower lip is of regular shape and size, and has a correct insertion site. The frenulum of the upper lip is enlarged in the mesiodistal dimension in the upper third and has a correct insertion site. Occlusion: the first permanent molars of the upper and lower jaws occlude mesiodistally according to Angle's class II, the canines correspond to Angle's class III, the midlines of the upper and lower dental arches coincide with each other and the midplane of the face. The buccal cusps of the upper lateral teeth overlap and closely contact the buccal cusps of the lower lateral teeth. The upper incisors contact the lower incisors.

Caries intensity index (CII) = 2.

Greene-Vermillion Index (OHI-S) - 0.6.

The Fedorov-Volodkina oral hygiene index is 1.1 (good).

RMA in Parma modification - 4%.

The TER test showed a low risk of enamel demineralization.

The staining intensity was 20%.

According to the stated method - average risk (M-CSF level in oral fluid 1 day before installation of the bracket system - 1100 pg/ml), 10 days after installation of the bracket system - 1100 pg/ml, sIgA level - 0.5 ng/ml.

After 10 months of observation, despite high adherence to hygiene procedures, the following symptoms developed:

- chalky spots on the enamel (around the braces);

- enamel hyperesthesia.

The above symptoms confirm the effectiveness of the proposed method.

Example 3.

Patient G., 18 years old.

Complaints: delayed temporary teeth in the upper jaw; incorrect positioning of teeth in the upper jaw.

Extraoral examination. The face is oval, medium in size, and symmetrical. Visually, the lower face is deficient, with the lower third of the face reduced. The gaze is direct. The nasolabial folds are not pronounced, and the chin is smoothed. The lips meet along the Klein line without tension. The profile is slanted posteriorly. The mouth opens freely to 3 cm. Mandibular movements are normal and painless.

Intraoral examination. The oral vestibule is 6 mm. The gingiva is pale pink, the interdental papillae are a regular triangular shape with pointed apices, the frenulum of the lower lip is of regular shape and size, and has a correct insertion site. The frenulum of the upper lip is enlarged in the mesiodistal dimension in the upper third and has a correct insertion site. Occlusion: the first permanent molars of the upper and lower jaws occlude mesiodistally according to Angle's class I, the canines occlude according to Angle's class II, the midlines of the upper and lower dental arches coincide with each other and the midplane of the face. The buccal cusps of the upper lateral teeth overlap and closely contact the buccal cusps of the lower lateral teeth. The upper incisors contact the lower incisors.

Caries intensity index (CII) = 1.

Greene-Vermillion Index (OHI-S) - 0.4.

The Fedorov-Volodkina oral hygiene index is 1.0 (good).

RMA in Parma modification - 3%.

The TER test showed a low risk of enamel demineralization.

The staining intensity was 30%.

According to the stated method, the risk is low (the level of M-CSF in the oral fluid 1 day before the installation of the bracket system is 100 pg/ml), 10 days after the installation of the bracket system - 100 pg/ml, the level of sIgA is 0.5 ng/ml.

After 10 months of observation, there are no symptoms of enamel demineralization.

Example 4.

Patient A., 19 years old.

Complaints: presence of gaps between teeth on the lower jaw; aesthetic disturbances.

Extraoral examination. The face is oval, medium in size, and symmetrical. Visually, there is a deficit in the midface, with the lower third of the face enlarged. The gaze is direct. The nasolabial folds are prominent, and the chin is not smoothed. The lips meet along the Klein line without tension. The profile is slanted forward. The mouth opens freely to 4 cm. Mandibular movements are normal and painless.

Intraoral examination. The oral vestibule is 9 mm. The gingiva is pale pink, the interdental papillae are a regular triangular shape with pointed apices, the frenulum of the lower lip is of regular shape and size, and has a correct attachment site. The frenulum of the upper lip is enlarged in the mesiodistal dimension in the upper third and has a correct attachment site. Occlusion: the first permanent molars of the upper and lower jaws close mesiodistally according to Angle's class I, the canines correspond to Angle's class II, the midlines of the upper and lower dental arches coincide with each other and the midplane of the face. The buccal cusps of the upper lateral teeth overlap and closely contact the buccal cusps of the lower lateral teeth. The upper incisors contact the lower incisors.

Caries intensity index (CII) = 3.

Green-Vermillion Index (OHI-S) - 0.5.

The Fedorov-Volodkina oral hygiene index is 1.0 (good).

RMA in Parma modification - 5%.

The TER test showed a low risk of enamel demineralization.

The staining intensity was 20%.

According to the stated method - high risk (M-CSF level in oral fluid 1 day before installation of the bracket system - 1100 pg/ml), 10 days after installation of the bracket system - 1400 pg/ml, sIgA level - 0.5 ng/ml.

After 10 months of observation, despite high adherence to hygiene procedures, the following symptoms developed:

- chalky spots on the enamel (around the bracket system and on the contact surfaces of the canines);

- enamel hyperesthesia.

The above symptoms confirm the effectiveness of the proposed method.

Thus, Examples 1, 2, and 4 illustrate the significance of using methods for calculating the risk of enamel demineralization in patients undergoing orthodontic treatment using the NOT and the proposed approach. This approach provides higher accuracy compared to the classic TER test, which does not take into account M-CSF and sIgA levels in oral fluid, individual reference values, or the dynamics of indicators in the 10-day period prior to NOT placement and over 12 months of orthodontic treatment. Example 3 demonstrates agreement in the qualitative risk assessment—"low"—which coincided with the actual data.

The obtained results confirmed the proposed hypothesis regarding the prognostic value of measuring M-CSF and sIgA levels in oral fluid. Thus, patients who developed demineralization during the described orthodontic treatment were characterized by predictively lower levels of both M-CSF and sIgA in oral fluid in those who subsequently developed demineralization. These immune factors should ensure control of bacterial overgrowth during the placement of braces.

Compared to known solutions, the claimed invention allows for increased accuracy in calculating the individual risk of developing enamel demineralization in patients using NOT within 12 months after installing the brace system by analyzing changes in the M-CSF level in oral fluid 1 day before and 10 days after installing the brace system, as well as the sIgA level in oral fluid 1 day before installing the brace system, regardless of age.

Table

Indicator Levels M-CSF, pg/ml, 1 day before installation of the bracket system more than 1100 less than or equal to 1100 M-CSF ratio, 10 days to 1 day before bracket system installation (%) not applicable more than 50 less than or equal to 50 less than or equal to 50 sIgA, g/L on the day of installation of the bracket system not applicable not applicable more than 0.5 g/l less than or equal to 0.5 g/l Absolute risk of complications [95% CI] 0 cases out of 87 people. 2 cases 16 people. 3 out of 17 people 15 cases out of 21 people. 0 12.5*
[6.05-46.9] 17.6
[7.44-53.9] 71.4 *
[64.3-92.4] Note:
* - when calculating the risk ratios, 95% CI did not include 1 (p < 0.5)

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Claims (6)

A method for determining the risk of enamel demineralization in patients using a brace system, characterized by the fact that one day before the installation of the brace system, on an empty stomach and before using oral hygiene products, oral fluid is collected in which the levels of M-CSF and sIgA are determined, then ten days after the installation of the brace system, M-CSF is determined in the oral fluid; with an M-CSF level from 110 to 1100 pg/ml in the oral fluid of patients 1 day before the installation of the braces system, followed by an increase in the M-CSF level on the 10th day by 50% or less and an sIgA level of 0.5 g/l or less, a high risk of enamel demineralization is determined; with M-CSF levels from 110 to 1100 pg/ml in the oral fluid of patients 1 day before the installation of the brace system, followed by an increase in M-CSF levels on the 10th day by 50% or less and an sIgA level of more than 0.5 g/l or with an M-CSF level of 1100 pg/ml in the oral fluid of patients 1 day before the installation of the braces system and maintaining the same concentration on the 10th day and an sIgA level of more than 0.5 g/l, an average risk of enamel demineralization is determined; At an M-CSF level of 110 pg/ml or less in the oral fluid of patients 1 day before the installation of the braces system, regardless of the dynamics of the M-CSF level on the 10th day and regardless of the sIgA level, a low risk of enamel demineralization is determined.