Effect of Treatment with Selective Caries Removal Associated to Antimicrobial Photodynamic Therapy on Children’s Oral Health-Related Quality of Life: A Non-Randomized Clinical Study

Introduction

Minimal invasive dentistry prioritizes conservative intervention when a surgical approach is necessary, reducing the loss of dental tissue. In more advanced caries lesions, several techniques have been developed to stop the progression of the lesion and its possible pulp involvement. The selective caries removal (SCR), recommends conservative caries removal and it has been showing positive results with the reduction of the risk of pulp exposure and preservation of healthy dental structure [1].

Associated with this technique, the use of antimicrobial photodynamic therapy (aPDT) has been used as an adjunct in the cavity preparation [2, 3]. According to the literature, aPDT seems to be efficient to reduce microorganisms in carious dentin in deep caries [2, 3]. Moreover, in vitro studies it is suggested that aPDT may be used in cavities with enamel margins to decrease the microbial load and prevent secondary caries [4]. In addition, studies recently published have been observed that the performance of primary molar resin restorations was not affected by SCR associated to aPDT after 6 and 12 months of follow-up [5, 6, 7].

Dental patient-reported outcomes (dPROs) and their Patient-Reported Outcome Measures (dPROMs) are fundamental for evidence-based dentistry. How patients perceive impact of diseases is an essential component when characterising different disease impacts, and effects of dental treatments should be perceived by the patients. The widely used concept oral health–related quality of life (OHRQoL) is the most important dPRO.[8] In the literature, it is observed that the treatment of caries improves OHRQoL [9]. However, there are no studies that assess the impact on OHRQoL of caries treatment using aPDT as an adjunct to SCR for the treatment of deep caries. Thus, this study aimed to assess the impact on conservative treatment of deep caries lesions using the selective caries removal (SCR) associated to a low laser therapy (antimicrobial photody-namic therapy–aPDT) on OHRQoL.

MATERIALS AND METHOD

This before-and-after não randomized clinical study was conducted in accordance with CONSORT standards [10] and registered in the ClinicalTrials.gov (NCT # 02908789 and in the Brazilian clinical trial platform–ReBEC (UTN# U1111-1183-0523). The clinical interventions were conducted in a public health institution, following the approval of the local Ethics Committee in Research (CAAE: 46451115.1.0000.5626/protocol number: 1177743). All procedures were performed with the permission of patients and their caregivers, by reading and signing the terms of free and enlightened assent and consent, respectively.

RESULTS

One hundred and thirty participants were acessed for elegibility, from those, 34 were eligible for the study and 26 participants were included the final analysis. Ten participants were lost and the reason was not return until 3 months after treatment to answer the OHRQoL questionnaire (Fig. 1). The sample mean age was 6.15 ($\pm$ 1.48), 09 (34.6%) was male and 17 (65.4%) was female. Regarding socio-economic classification 16 (61.5%) were from class C1 and C2 and 10 (38.5%) from class D and E. The dmft and DMFT indexes mean was 5.42 ($\pm$ 3.05) and 0.19 ($\pm$ 0.63) respectively. The oral hygiene index was 76.9%, which is good. In the sample, there were only 2 (7.7%) cases of children with malocclusion and 4 (15.3%) with dental trauma (Table 1) that did not influence the impact on OHRQoL (p $>$ 0.05) (Table 2).

Fig. 1.Fluxogram describing participant flow.

The mean impact on OHRQoL total scale was 5.46 ($\pm$ 4.55) before and 2.42 ($\pm$ 3.55) after treatment (p $<$ 0.01). In the child subscale it was 4.42 ($\pm$ 3.36) before and 2.12 ($\pm$ 3.19) after treatment (p $<$ 0.01). In the family subscale, the impact on OHRQoL was 1.04 ($\pm$ 2.16) before and 0.31 ($\pm$ 0.74) after treatment (p = 0.04). In child subscale, the symptoms domain had a mean of 1.27 ($\pm$ 1.15) before and 0.54 ($\pm$ 0.95) after treatment (p $<$0.01). The function domain had a mean of 2.12 ($\pm$ 1.90) before and 0.92 ($\pm$ 1.29) after treatment (p $<$ 0.01). The psychological domain had a mean of 0.81 ($\pm$ 1.52) before and 0.65 ($\pm$ 1.47) after treatment (p = 0.35). The self-image/social interaction domain averaged 0.23 ($\pm$ 0.59) before and zero after treatment (p = 0.05). Thus, it was possible to observe that only the psychological domain did not have a statistical difference (p $>$ 0.05).

In the family subscale, the domain of parental suffering had a mean of 0.73 ($\pm$ 1.54) before and 0.15 ($\pm$ 0.54) after treatment (p = 0.04) and the domain of family function had a mean of 0.31 ($\pm$ 1.05) before and 0.15 ($\pm$ 0.54) after treatment (p = 0.21), the latter showing no statistical difference (Table 3).

Table 4 shows the results of longitudinal validity and responsiveness testing by SRM The impact on OHRQoL after treatment evaluated by ECOHIS demonstrated satisfatory longitudinal responsiveness except for psychological, self-image/social interaction and Family function domain (SRM$<$0.5 denoting small responsiveness).

DISCUSSION

Children’s OHRQoL are negatively influenced by untreated cavitated dentine lesions and their consequences [18]. Therefore, studying techniques that can restore function and aesthetics promoting quality of life is extremely important. The conservative treatment of deep caries (SCR + aPDT), did not influence negatively on OHRQoL demonstrating, after 3 months of follow up improvement the OHRQoL to these children and the family, with the reduction of the negative impact generated by the disease, thus confirming the importance of access to dental treatment and how it has influence on the well-being of individuals and the use of new technologies.

The literature has demonstrated that dental caries has a negative impact on children’s lives, affecting their physical and emotional well-being and that the treatment of oral disorders has restored the OHRQoL [19, 20]. Its treatment has been related to improvement in OHRQoL [9]. Thus, the present study is in agreement with what was pointed out in the literature, demonstrating that after dental treatment, pediatric patients had improvements both with regard to functionality and also in psychosocial aspects. These measures can help weigh risks and benefits, as well as assess the cost effectiveness of treatments, thus influencing treatment recommendations and health policies. The incorporation of these measures into a professional’s daily life not only represents an improvement in professional performance, but also addresses a humanitarian concern [21].

The present work sought to control biases by performing sample calculations and controlling factors that could potentially be confusing. However, as a limitation, as this is the first study to assess the impact on quality of life using a laser associated with a SCR technique, which makes greater comparisons with the literature was difficult. Hence, it is suggested more studies on this topic considering other groups of children to confirm or to refute the present findings.

In this study, only psychological domain (in child subscale) and family function domain (in family subscale) showed no statistical difference. It also was observed in the responsiveness evaluated by ECOHIS in relation to impact on OHRQoL after treatment. It is believed that the young age of the participants influenced the result of the psychological domain. Children with lower age are expected to be less impact on OHRQoL compared to those of a larger age due to a more advanced in the psychological development phase [22]. Regarding the family function domain, which includes the expenses of that family, there was possibly no statistical difference because it was a free service provided by a public institution.

The search for more scientific evidence, the adoption of a minimally invasive dentistry is increasing. Studies observed the non-necessity of total removal of carious dentin in deep cavities, since there is the possibility of recovery of the innermost layer and paralysis of the lesion of caries [23, 24, 25, 26]. Based on this philosophy, SCR showed an increase in radiopacity, a decrease in the depth of the lesion and deposition of tertiary dentin with high rate of success rate [27].

The advancement of aPDT’s knowledge is changing the current scenario in the area of health. aPDT used as an adjunct to SCR is a reality, reducing the removal of the dental structure during the management of the carious lesion with the guarantee of maximum reduction of microorganisms in the cavity before the restoration [3]. In addition, clinical studies have provided further support to indicate the association of aPDT with SCR, since it does not affect the longevity of composite resin restorations in primary molars [8, 28, 29]

The findings described in this study demonstrated that the association of a low laser therapy (aPDT) with SCR did not influence negatively on OHRQoL. In the practice of pediatric dentistry, this conservative dental treatment improved the OHRQoL after 3 months of follow up. These findings should be interpreted with caution. Other types of treatment and the consideration of more time follow up should also be evaluated suggesting new studies. However, this study is a first step to give more information about the application of aPDT on pediatric dental clinic considering a OHRQoL outcome. It can be one more advantage of the association of these techniques which, in addition to safely returning biological conditions, can also help in the return of health and psychosocial aspects, taking a holistic view of the patient. Knowledge about the impact of these procedures on OHRQoL is of pivotal importance in deciding whether to advocate the adoption of such treatments [21].

ACKNOWLEDGMENTS

We are indebted to the participants of the study. This study was support by Jovem Cientista Nosso Estado-Fundação de Amparo a pesquisa do Estado do Rio de Janeiro (FAPERJ E-26/202.712/2018) (LAA). LAA was supported by National Council for Scientific and Technological Development (CNPq) LP was supported by the Fundação de Amparo a pesquisa do Estado do Rio de Janeiro (FAPERJ/ E-26/202.974/2019). LVF was supportd by CAPES program for master degree.