The aim of this study was to compare the performance of two visual criteria used for the detection of caries around restorations in permanent teeth. In this delayed-type cross-sectional study, the study sample was randomly allocated to one of two visual criteria for the assessment of restorations as follows: (a) International Dental Federation (FDI) criteria, considers marginal staining, marginal adaptation, and caries recurrence and (b) Caries Associated with Restorations or Sealants (CARS) criteria, defined by the International Caries Classification and Management System. A calibrated examiner assessed the restorations using two reference standards as follows: (i) for restorations requiring operative interventions (repair/replacement), the restoration was partially or totally removed and the presence or absence of carious tissue was assessed; and (ii) for restorations requiring nonoperative intervention, follow-up for a period of 1 year was recommended to allow identification of the presence of new lesions not detected at baseline. The sensitivity, specificity, area under receiver operating characteristic curve (Az), and accuracy of the criteria were assessed. The study included 305 restorations. The FDI marginal staining parameter had the lowest Az value (Az = 0.501), while similar sensitivity was observed between the CARS (62.0%), FDI presence of caries (65.0%), and FDI marginal adaptation (74.0%) parameters. CARS exhibited the highest specificity (88.3%) and accuracy (85.6%). The CARS criteria exhibited better specificity and accuracy in detecting caries around restorations, followed by the FDI criteria for caries recurrence and marginal adaptation. Considering marginal staining or combining multiple marginal features to assess secondary caries resulted in an increased risk of false-positive outcomes and overtreatment.

Secondary dental caries, defined as “lesions at the margins of existing restorations,” are the most common indication for replacement of restorations [Mjör, and Toffenetti, 2000; Bücher et al., 2014; Moraschini et al., 2015; Askar et al., 2020; MacHiulskiene et al., 2020]. They typically occur as a result of a complex interaction of various factors including well-known causes of “conventional” caries (e.g., accumulation of microorganisms and ecological shifts under external pressure caused by excessive sugar consumption) and the specificities of individual restorations and restorative materials [Askar et al., 2020]. The carious process results in detectable demineralization at the margins of existing restorations, and the treatment of choice should be selected based on the clinical signs observed. However, existence of a restoration adjacent to a carious lesion raises questions regarding treatment protocols addressing them individually as well as in combination with one another.

Certain clinical features such as marginal staining, discoloration of the dental structure, and the appearance of small cracks in the restorative material associated with the normal degradation of restorations can be misdiagnosed as secondary caries [Brouwer et al., 2016; Demarco et al., 2017]. Misidentification of marginal defects in restorations as carious lesions may increase the number of false-positive cases, leading to overtreatment [Mjör, 2005]. Although visual inspection is the conventional method of caries detection around restorations, a limited number of studies have investigated the validity of the visual criteria used [Signori et al., 2018].

The two most frequently used criteria include the FDI (International Dental Federation) criteria [Hickel et al., 2010], and the Caries Around Restorations and Sealants (CARS) criteria proposed by the International Caries Classification and Management System [Pitts et al., 2016]. The FDI criteria, which are primarily used for the clinical evaluation of restorations, contain esthetic, functional, and biological parameters to be used during the assessments. It is a well-structured and flexible system of criteria that can be selected and adjusted according to the needs of the clinical investigation. Alternatively, the CARS criteria were designed exclusively to assess the caries’ lesions around restorations. It is also a well-designed system of criteria; however, it is focused on the detection of caries lesions and their severity. Although these criteria were designed for different purposes, they are internationally recognized and accepted in practice and, therefore, may serve as appropriate references for the comparison of the two main approaches used to diagnose secondary caries. These include a minimally invasive approach which takes into consideration the presence of a detectable carious lesion for diagnosis and intervention, and a more invasive approach which considers marginal defects in restorations as potential secondary caries and assigns operative treatment choices accordingly.

Accurate detection of caries around restorations directly impacts treatment choice, thus playing a significant role in either avoiding or promoting overtreatment [Signori et al., 2018]. Therefore, the current study aims to compare the clinical accuracy of the FDI and CARS criteria for the detection of caries around restorations in permanent teeth. The null hypothesis being tested was that there would be no differences in performance between the two methods.

This study was reported in accordance with the Standards for Reporting Diagnostic Accuracy Studies (STARD) Guideline (STARD checklist provided in online suppl. material; for all online suppl. material, see www.karger.com/doi/10.1159/000528730) [Bossuyt et al., 2015].

Study Design

This delayed-type cross-sectional study compared the performance of two index tests methods used for the detection of caries around restorations in permanent teeth as follows: (1) FDI criteria based on 3 parameters (caries presence, marginal adaptation, and marginal staining); and (2) CARS criteria defined by the International Caries Classification and Management System (online suppl. Table S1, S2). The study participants were randomly allocated to a criteria group (online suppl. Fig. S1). A calibrated examiner (C.S.) first assessed the restored teeth and identified the treatment of choice (nonoperative intervention, repair, or replacement) in accordance with the criteria assigned to the patient. Thereafter, immediately after, the same examiner reassessed the restoration using the second criteria. Two reference standards were used as follows: (i) for restorations indicated for operative interventions (repair/replacement), the restoration was partially or completely removed and the presence or absence of carious tissue was assessed; and (ii) for restorations indicated for nonoperative interventions, follow-up for a period of 1 year was recommended to allow evaluation of the presence of new lesions not detected at baseline. A second examiner (M.S.C.), blinded to the initial assessments, carried out the follow-up assessments after 1 year to minimize the risk of bias. The sensitivity, specificity, area under the receiver operating characteristics (ROC) curves (Az), and accuracy of outcome variables were analyzed.

Setting

This study is nested within the Caries Cognition and Identification in Adults (CaCIA) clinical trial (registered on Clinicaltrials.gov, number NCT03108586), and ethical approval was granted by the local Ethics Committee (No. 1.625.236/2016). The study participants signed an informed consent term prior to the participation in the study.

The CaCIA trial is a randomized controlled clinical trial that investigates the impact of using different visual criteria for the assessment of caries around restorations on the short and long-term oral health outcomes of adults. The study protocol has been published previously [Signori et al., 2020]. The clinical trial was carried out at the School of Dentistry from the Federal University of Pelotas (Pelotas, Brazil) in 2016, and the current study is part of a series of investigations conducted within the CaCIA clinical trial.

Eligibility Criteria

The study included individuals between the ages of 18 and 60 years old and identified as having at least one composite or amalgam restoration in a posterior tooth.

Exclusion Criteria

1 Refusal to participate in the study;

2 The presence of systemic conditions or chronic diseases that require specialized care and follow-up;

3 Restorations on teeth with conditions such as fractures, fistula, abscess, pulp exposure, history of spontaneous dental pain, or mobility.

Index Criteria

FDI Criteria

The FDI criteria, a well-known system used to evaluate direct and indirect restorations, are categorized into three groups based on aesthetic, functional, and biological parameters. In the present study, the three criteria used to assess the presence of caries around restorations in permanent teeth included: (1) marginal staining; (2) marginal adaptation; and (3) caries recurrence (online suppl. Table S1). Each parameter within the criterion was assigned a score from 1 to 5, where 1 = clinically excellent/very good; 2 = clinically good; 3 = clinically sufficient/satisfactory; 4 = clinically unsatisfactory and repair indicated; and 5 = clinically poor and replacement indicated.

CARS Criteria

The CARS criteria [Pitts et al., 2016; Martignon et al., 2019] assesses the presence and severity of carious lesions around the restored tooth and assigns a score ranging from 0 to 6, where 0 = sound tooth surface; 1 = first visual change in enamel; 2 = distinct visual change in enamel/dentin adjacent to the restoration margin; 3 = carious defects of <0.5 mm with signs of code 2; 4 = marginal caries adjacent to the restoration accompanied by the presence of an underlying dark shadow in the dentin; 5 = distinct cavity adjacent to the restoration; and 6 = extensive cavity with visible dentin (online suppl. material. Table S2).

The criteria also assess carious lesion activity, classifying it into active or inactive lesions [Nyvad et al., 1999]. A lesion is considered active if the enamel is whitish/yellowish in color, exhibits opacity and loss of luster, roughness, and susceptibility to plaque accumulation, and the dentin appears soft or leathery in consistency. Enamel lesions that are whitish, brownish, or black in appearance and dentinal lesions that are shiny and hard on gentle probing are also considered inactive [Nyvad et al., 1999].

Reference Standard Method

Two reference standards, determined based on the treatments assigned to each restoration (operative or nonoperative treatment), were used to assess the validity of the criteria. The reference standard for operative treatment involved partial or total removal of the restoration and assessment of the presence or absence of decayed tissue, while that for nonoperative treatment included follow-up of the restoration for a period of 1 year.

Restorations Requiring Operative Treatment (Repair/Replacement)

The presence or absence of decayed tissue upon partial (repair) or total (replacement) removal of the restoration was assessed in patients advised to undergo operative treatment at baseline.

The restorative materials were carefully removed by trained undergraduate and graduate students, with the whole restoration being removed where replacement was indicated and only part of the restorative material being removed where repair was indicated. The trained undergraduate and graduate students were closely supervised by a trained examiner who performed the visual-tactile inspection to assess the tooth for the presence or absence of decayed tissue [Pitts et al., 2016]. Decay was said to be present if the dentin appeared discolored and soft or leathery in consistency [Nyvad et al., 1999].

Restorations Requiring Nonoperative Treatment

Restorations not requiring operative treatment were followed up for a period of 1 year, based on previous evidence suggesting that this was the preferred alternative when compared to unnecessary removal and treatment of satisfactory restorations [Knottnerus, and Buntinx, 2009]. After 1 year, the restorations were reevaluated to enable identification of lesions that were not detected at baseline, potentially due to the fact that they were still in the early stages of development, and the need for intervention was determined based on the findings.

Examiner Training

The two examiners (C.S. and M.S.C.) who carried out assessment of restorations underwent appropriate training prior to commencement of the study. The training protocol was divided into two phases. In the first phase, a series of photos with restorations exhibiting marginal defects were presented to the examiners on a 50" high-definition television screen in a dark room, and they were asked to discuss the evaluation and treatment of each case using the FDI and CARS criteria.

In the second phase, performed at the clinic, the examiners individually assessed a total of 20 patients using the FDI and CARS criteria, and the recommended diagnosis and treatment for each case wer0065 recorded. The answers were then compared, and any disagreements were discussed to enable establishment of a consensus.

One examiner (C.S.) was responsible for randomizing patients to the criteria groups, while the other examiner (M.S.C.) carried out the follow-up assessments after 1 year. A second examiner was included to perform the follow-up assessments to minimize the risk of bias since the first examiner had access to the group in which the patient was randomized.

Study Randomization and Examination

The patients were first examined in a dental chair under suitable lighting, and dental cleaning using a low rotation micromotor with a rubber cup and prophylactic paste was carried out. A visual inspection of the dental surfaces was performed in accordance with the International Caries Detection and Assessment System (ICDAS) [Martignon et al., 2019] for screening, and the DMF-T (Decayed-Missing-Filled Teeth) index and caries activity were assessed.

The patients were randomly allocated to the criteria groups (FDI or CARS). The random list was generated via the website (www.sealedenvelope.com). The study participants were allocated via stratified randomization by blocks. The strata were (1) DMF-T index ≤4 without caries activity; (2) DMF-T index ≤4 with caries activity; (3) DMF-T >4 without caries activity; and (4) DMF-T >4 with caries activity. To ensure allocation confidentiality, opaque, sealed, and consecutively numbered envelopes were used. A trained examiner evaluated and scored the restorations in accordance with the randomized criteria (shown in online suppl. Tables S1, S2). Additionally, a treatment plan (no treatment, repair, replacement, or topical fluoride application) was established based on the criteria scores [Hickel et al., 2010; Pitts et al., 2016] for the CARS group. Thereafter, in order to allow comparisons between the criteria, the restorations were reassessed using the criteria from the opposite group, and the data were only recorded for analysis purposes, and the treatment plan assigned previously was retained.

Study Blinding

This study used a triple blinding methodology, wherein the examiner (C.S.) performing baseline assessment was blinded to the reference standard results, the undergraduate and graduate students performing restoration removal were blinded to the reasons for intervention, and the examiner (M.S.C.) performing the follow-up assessment was blinded to the clinical details of the patients.

Statistical Analysis

The sample was retrieved from the ongoing clinical trial described previously, and a descriptive analysis of the restorations included in this study was carried out. Therefore, sample size calculation was based on the primary endpoint of this clinical trial and details can be found elsewhere [Signori et al., 2020].

The FDI criteria resulted in the following variables: FDI presence of caries; FDI marginal adaptation; FDI marginal staining; and the FDI global criterion. The highest scores from each of the 3 parameters were used to calculate the final score, and this was used to create a dichotomous variable, the FDI global criterion, where FDI scores 1–3 = sound and FDI scores 4–5 = decayed. Therefore, the extreme cases (FDI scores 4–5) were considered as exhibiting “presence of caries” for the purpose of analysis. A similar procedure was also used for the CARS criteria, with the scores being categorized into “no presence of caries” (scores 0–3, as well as those assigned scores 4–6 and exhibiting inactive lesions) and “presence of caries” (scores 4–6 with evidence of caries activity).

The Az and the respective 95% confidence intervals (95% CI) were calculated taking the scores for the CARS, FDI presence of caries, FDI marginal adaptation, FDI marginal staining, and FDI global parameters into consideration. The Az was not calculated for the FDI global criterion as it was a dichotomous variable. Comparison of Az was carried out using the Hanley and McNeil approaches. The index criteria had no missing data. Regarding the accuracy parameters, cut-off points were predetermined based on the criteria and the sensitivity, specificity, and accuracy (percentage of correct diagnoses considering both sound and decayed teeth) were calculated using the McNemar test and preestablished cut-off points.

The sample characteristics have been presented in Table 1. The study sample included 96 patients, the majority of which were women. The mean age was 42.8 years, and the mean DMF-T score was 12.6. A total of 305 restorations were included in the study, and the majority were composite resin restorations involving less than 4 surfaces.

Table 1.

Characteristics of the sample of patients/restorations included in the study

 Characteristics of the sample of patients/restorations included in the study
 Characteristics of the sample of patients/restorations included in the study

Figure 1 shows a diagrammatic flow of the restoration assessments at baseline by criteria group. The FDI criteria diagnosed 75 out of 182 restorations as having secondary caries, while 18 out of 123 restorations were diagnosed with the same when using the CARS criteria. Table 2 shows the descriptive analyses relating the diagnostic method with the tooth condition according to the reference method. Of 305 restorations, 93 were indicated for operative treatment (repair or replacement) and 212 for nonoperative treatment at the baseline evaluation. The reference standards showed presence of carious lesions in 31 restorations (10.2% of decayed teeth).

Table 2.

Descriptive analyses relating the diagnostic method with the tooth condition

 Descriptive analyses relating the diagnostic method with the tooth condition
 Descriptive analyses relating the diagnostic method with the tooth condition
Fig. 1.

Diagrammatic flow of the restoration assessments at baseline by criteria group.

Fig. 1.

Diagrammatic flow of the restoration assessments at baseline by criteria group.

Close modal

Table 3 presents the best cut-off points, Az, sensitivity, specificity, and accuracy of the different methods. No differences in Az were observed for the CARS, FDI presence of caries, and FDI marginal adaptation parameters. Only the FDI staining criterion, due to its lower Az value (Az = 0.501), exhibited a statistically significant difference when compared with the other criteria.

Table 3.

Az, best cut-off points, sensitivity, specificity, and accuracy of the different diagnostic criteria assessing caries lesions around restorations

 Az, best cut-off points, sensitivity, specificity, and accuracy of the different diagnostic criteria assessing caries lesions around restorations
 Az, best cut-off points, sensitivity, specificity, and accuracy of the different diagnostic criteria assessing caries lesions around restorations

The sensitivity was similar between the CARS (62.0%), FDI presence of caries (65.0%), and FDI marginal adaptation (74.0%) parameters, while the values were significantly higher for the FDI global (90.3%) and significantly lower for the FDI staining (28.6%) parameters. Specificity values were similar for the FDI presence of caries, FDI adaptation, and FDI staining parameters. The highest (88.3%) and lowest (65.3%) values were observed for the CARS and the FDI global criteria, respectively. The accuracy was higher when using the CARS criteria (85.6%) in comparison to the FDI global criteria (67.9%). The analysis of the FDI presence of caries and marginal adaptation combined showed higher accuracy (83.9%) and specificity (72.6%) compared to FDI global but lower values compared to CARS.

The findings of this study showed better accuracy in secondary caries detection when using a diagnostic method that considered only the characteristics of the carious lesion (CARS criteria) compared to a method that also included parameters related to the restoration itself (such as marginal staining and marginal adaptation). The FDI group represented a more invasive approach as it considered marginal defects as potential secondary caries, a factor that is often mistaken for caries around restorations. The findings suggest that marginal staining is not a good criterion for the detection of caries around restorations. However, the sensitivity values were similar for the CARS, FDI presence of caries, and marginal adaptation parameters, although the specificity was higher when using the CARS criteria.

The FDI criteria, developed by the International Dental Federation [Hickel et al., 2010], have been widely used in previous studies [Marquillier et al., 2018]. The current study, in addition to examining the presence of recurrent caries, also assessed marginal staining and marginal adaptation in accordance with the FDI system. This was done mainly due to the fact that deep marginal staining and/or lack of marginal adaptation may lead to erroneous detection of secondary caries by dentists, highlighting the importance of demonstrating the reliability of these parameters in the diagnosis of secondary caries.

Although the FDI global criteria had higher sensitivity, it also exhibited lower specificity implying higher false-positive rates. This can be attributed to the fact that the FDI global criteria also identified parameters such as marginal staining and marginal adaptation as carious lesions, in addition to the recurrent carious lesion itself. The FDI staining criterion alone exhibited low sensitivity, and marginal staining was only evaluated for composite resin restorations which may be considered as a limitation of this study. The majority of amalgam restorations result in pigmentation naturally promoted by the presence of the material on the dental structure, often leading to overestimation of caries around amalgam restorations.

It is important to highlight that the main aim of the FDI system is to evaluate the quality of the restorations, and it is typically used in dental research and not on a daily basis by dentists. Therefore, it is a suitable criterion for the evaluation of the quality of restorations, especially in clinical studies in restorative dentistry. However, the treatment decisions made based on this system should take into consideration the clinical relevance of the parameters scored by the criterion. For example, a posterior restoration assigned a score of 5 for marginal staining should not be indicated for replacement if the other parameters are clinically acceptable.

The CARS and FDI presence of caries criteria exhibited comparable sensitivity and this could be attributed to the fact that they are both based on lesion severity [Hickel et al., 2007] with minor differences. Both criteria score the caries lesion according to its severity, evaluating the presence of enamel opacities and dentine cavities. A strong positive correlation between CARS and the parameters used by the FDI to assess caries recurrence was observed in a recent study [Signori et al., 2022]. Thus, the FDI criterion specified for caries recurrence is a suitable criterion for the assessment of caries lesions around restorations. However, the FDI criteria do not consider the lesion activity, which could improve this parameter in the FDI system.

Nevertheless, both FDI global and FDI adaptation/caries presented lower accuracy and specificity when compared to the CARS criteria, although when marginal staining was considered with the two criteria the results were lower. The combined use of lesion parameters and multiple marginal features of the restoration for the detection of carious lesions around restorations can result in high false-positive rates, leading to overtreatment, unnecessary loss of tooth structure through operative interventions and, consequently, unnecessary increases in public or private healthcare costs. These findings suggest that the CARS criteria had the best accuracy, which is directly related to diagnostic precision. A recent study also showed that the evaluation method used to assess restorations has a direct impact on the decision to replace the restoration or not [Moro et al., 2020].

The differences between FDI criteria on the basis of the presence of caries, marginal adaptation and staining criteria (adapted from the FDI criteria), and CARS criteria regarding the decision to intervene or not in restorations were recently published [Signori et al., 2022]. When assessing the same restoration, FDI criteria indicated 5X more replacements when compared to the CARS, considering the presence of caries and marginal adaptation and staining criteria as caries lesion predictors. Although there was a difference in the proportion of invasive interventions between the FDI (41.2%) and CARS (14.6%) groups, all the restorations were evaluated by both the criteria. Moreover, the accuracy analysis was performed considering the standard reference method decided by the randomized criteria, whether invasive or not.

In the current study, only one examiner assessed both criteria at baseline and this may seem like a study limitation. However, the inclusion of more examiners would result in increased outcome variability and, therefore, this study used standardized systems and only one examiner for precise execution of the assessments in accordance with the criteria protocol to minimize inconsistencies in measurements. The lack of statistical methods ensuring the ability of the examiner to record the same conditions in the same way over time and to measure agreements between the examiners is a study limitation. However, the examiners were trained prior to assessments, and consensus between examiners was achieved by means of discussion. We believe that the use of well-defined criteria based on a valid scoring system with a detailed description can ensure intra- and inter-examiner reproducibility, and this has been supported by previous evidence that suggests that intra-examiner reliability is high with regard to caries detection and remains so over the time [Qudeimat et al., 2016].

In the current study, removal of the restoration or follow-up for a period of 1 year was used as the reference standards for verification of preexisting and unidentified lesion progress in teeth requiring operative and nonoperative interventions, respectively. The follow-up of a year instead of removal of the restoration is a limitation of the study. The removal of all the restorations would be too invasive. The alternative was based on the follow-up of the disease’s clinical course during a suitable predefined period as applying a definitive reference standard would be too invasive [Knottnerus, and Muris, 2003]. Most diseases that are not self-limiting (chronic diseases) will become clinically evident few months after the enrolment in the study [Knottnerus, and Muris, 2003]. Moreover, this type of reference standard (clinical follow-up) was already used in a diagnostic accuracy study for the detection of caries lesions around restorations [Moro et al., 2022]. The use of two reference standards and the lack of histological assessment may be considered a study limitation as use of the same reference metric for confirmation of carious lesions in all restorations would be preferable.

In conclusion, the CARS criteria exhibited better specificity and accuracy in detecting caries around restorations, followed by the FDI criteria for caries recurrence and for marginal adaptation. Considering marginal staining or combining multiple marginal features to assess secondary caries resulted in an increased risk of false-positive outcomes and overtreatment. Finally, the use of diagnostic criteria with good accuracy, specificity, and sensitivity enables accurate diagnosis and better treatment choices.

The authors would like to thank the CaCIA and CARDEC collaborative groups. Both collaborative groups have shared the ideas and collaborated to the planning and establishment of the present study. Members of the group can be found at https://sites.usp.br/cardec/info/grupos_parceiros/cacia-trial-1/grupo-de-colaboradores/.

  • CaCIA collaborative group

Ana Beatriz L. Queiroz, Alessandra B. Avila, Bruna O. Souza, Camila R. Dias, Camila T. Becker, Eduardo T. Chaves, Eugênia C. Malhão, Elenara F. Oliveira, Fernanda G. Silva, Fernanda S. Silva, Gabriel V.L. Kucharski, Gabriele R. Santos, Julia M. Torres, Karoline V.A. Pinto, Laura L. Morel, Leonardo B. Weymar, Marcelo P. Brod, Maria Fernanda Gamborgi, Renata U. Posser, Thaís S. Vieira, Wagner S. Nolasco, and Wagner M.S. Leal.

  • CARDEC collaborative group – trial 3

Ana Laura Passaro, Annelry C. Serra, Antonio Carlos L. Silva, Bruna L.P. Moro, Carolina P. Acosta, Caroline M. Laux, Cíntia S. Saihara, Daniela P. Raggio, Haline C.M. Maia, Isabel Cristina O. Costa, Isabella R. Almeida, Jhandira Daibelis Yampa-Vargas, Jonathan R. Garbim, José Carlos P. Imparato, Julia G. Freitas, Karina H. Natal, Kim Rud Ekstrand, Laura Regina A. Pontes, Mariana Bifulco, Mariana M. Braga, Mariana P. Araújo, Mayume A. Vale, Raiza D. Freitas, Renata M. Samuel, Rita Baronti, Rodolfo C. Oliveira, Simone Cesar, Tamara K. Tedesco, Tathiane L. Lenzi, Tatiane F. Novaes, and Thais Gimenez.

All procedures performed were in accordance with the ethical standards of the Institutional Research Committee and with the 1964 Helsinki declaration and its later amendments. This study protocol was reviewed and approved by the local Ethics Committee from Federal University of Pelotas (Rio Grande do Sul, Brazil) under the approval number: No. 1.625.236/2016. The study participants signed an informed consent term prior to the participation in the study.

The authors have no conflicts of interest to declare.

The study was supported by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – (CAPES) Brasil– Finance Code 001. The institution had no role in study design, data collection, and analysis, decision to publish, or preparation of the manuscript.

Juliana Lays Stolfo Uehara and Cácia Signori: conceptualization, methodology, investigation, and writing - original draft; CaCIA collaborative group and Vitor Henrique Digmayer Romero: conceptualization, methodology, and investigation; Fausto Medeiros Mendes: formal analysis, investigation, supervision, and writing - review and editing; Maximiliano Sérgio Cenci: conceptualization, investigation, supervision, and writing - review and editing.

The datasets generated and/or analyzed during the current study are not publicly available. The datasets will be available in a public repository after the acceptance of the manuscripts using the data derived from the clinical trial previously mentioned. Further inquiries can be directed to the corresponding author.

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