|Year : 2021 | Volume
| Issue : 2 | Page : 202-207
Pain perception of children after restorative treatments: Atraumatic restorative treatment versus chemomechanical removal – A noninferiority randomized clinical trial
Aline Maquiné Pascareli-Carlos1, Laíza Fernandes Martins2, Monicque da Silva Gonçalves3, José Carlos Pettorossi Imparato4, Tamara Kerber Tedesco1
1 Graduate Programme in Dentistry, Ibirapuera University, São Paulo, Brazil
2 Graduate Programme in Dental Science, School of Dentistry, Federal University of Uberlândia, Uberlândia, Brazil
3 Department of Pediatric Dentistry, School of Dentistry, Nilton Lins University, Manaus, Brazil
4 Graduate Programme in Dentistry, Faculdade São Leopoldo Mandic, São Leopoldo Mandic Institute, Campinas, Brazil
|Date of Submission||01-Oct-2020|
|Date of Decision||11-Dec-2020|
|Date of Acceptance||02-Jun-2021|
|Date of Web Publication||29-Jul-2021|
Dr. Tamara Kerber Tedesco
Ibirapuera University, Av. Interlagos, 1329, Sao Paulo, SP 04661-100
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Atraumatic restorative treatment (ART) and chemomechanical removal of dental caries have been shown to be safe and effective restorative procedures. However, current literature lacks well-design studies comparing the pain perceived by infants using ART and chemo-mechanical removal techniques. Aims: To compare pain perception of children of two techniques (ART vs. chemomechanical removal) of restorative treatments for dental caries removal. Settings and Design: A randomized clinical trial with two parallels arms (1:1) was conducted in the cities of Manaus (AM) and Uberlândia (MG), Brazil. Methods: Children between 4 and 9 years old were selected. In both groups - ART (n = 20) and chemomechanical caries removal (Papaya® gel) (n = 20) - oximeter measurements (heart rate and blood oxygenation) were performed before the intervention and until the complete removal of the infected caries dentin. At the end of the treatment, a Wong-Baker scale was used to assess pain perception during the procedure. An independent researcher measured, in minutes, the duration of each technique. Statistical Analysis: Poisson regression analysis was used to evaluate the association between the outcome and the explicative variables. Results: No statistical difference in pain perception between the two procedures of carious tissue removal was observed. By contrast, a lower heart rate was observed when chemomechanical removal was used (P = 0.013). Conclusion: Children that underwent chemomechanical caries removal presented lower heart rate compared to those who underwent ART. However, both techniques showed minimal or absent perceived pain.
Keywords: Dental caries, dental restoration permanent, tooth deciduous
|How to cite this article:|
Pascareli-Carlos AM, Martins LF, Silva Gonçalves Md, Pettorossi Imparato JC, Tedesco TK. Pain perception of children after restorative treatments: Atraumatic restorative treatment versus chemomechanical removal – A noninferiority randomized clinical trial. J Indian Soc Pedod Prev Dent 2021;39:202-7
|How to cite this URL:|
Pascareli-Carlos AM, Martins LF, Silva Gonçalves Md, Pettorossi Imparato JC, Tedesco TK. Pain perception of children after restorative treatments: Atraumatic restorative treatment versus chemomechanical removal – A noninferiority randomized clinical trial. J Indian Soc Pedod Prev Dent [serial online] 2021 [cited 2022 Aug 11];39:202-7. Available from: http://www.jisppd.com/text.asp?2021/39/2/202/322510
| Introduction|| |
Anxiety and discomfort associated with dental treatment are the essential aspects in pediatric dentistry, with at least 14.4% of children aged 5–12 years old expressing dental anxiety. A systematic review focused on patient-reported outcomes showed that anxiety and pain are directly related to more invasive restorative treatment in children dental care. The pain associated with fear, which is often related to the use of rotating instruments, causes patients to avoid seeking care. This is another reason for dentists and guardians to ensure the dental appointment is as pleasant as possible.
Several treatment options can be used to manage dental caries, including atraumatic restorative treatment (ART), and chemomechanical removal.,,, ART causes less pain due to the nonuse of local anesthetics, rubber dam, and hand instruments. Hence, it is considered a patient-friendly treatment. However, even though ART is regarded as an atraumatic approach, a systematic review showed no evidence to support that this reduces anxiety among patients compared to conventional treatments.
Consequently, chemomechanical removal has been suggested as an alternative to decrease anxiety among patients due to its easiness in removing carious tissue. This technique uses a papain/chloramine-based gel (Papacárie®) to dissolve the contaminated carious tissue, thus facilitating its minimally invasive removal in combination with hand tools. Conversely, this technique could be more time-consuming,, which could be unfavorable to anxiety.
The current literature lacks well-designed studies comparing which technique results in less pain in infants during restorative procedures. Most studies compared both techniques with conventional restorative treatment,,, causing difficulty in understanding children's perceptions regarding these techniques. Understanding this panorama could guide pediatric dentistry in the choice of restorative techniques, especially in patients with fear and anxiety concerning dental care. Thus, this study aimed to compare the pain perception of the children during caries removal using two restorative treatments: ART and chemomechanical removal. It was hypothesized that the use of chemomechanical caries removal is not inferior to ART in the pain perception of the children.
| Methods|| |
Study design and ethical aspects
A noninferiority, blind (researcher responsible for assessing outcomes), with two parallel arms (1:1), randomized clinical trial was conducted and reported according to CONSORT Statement for randomized clinical trials. This study was previously approved by the Local Committee for Ethics in Research (protocol number 087489/2016) and registered in the database to register clinical studies (Clinicaltrials.gov NCT03143387). Written informed consent was obtained from all children's parents or legal guardians before evaluations.
Sample size and selection
For the sample size calculation, it was considered the mean of pain with ART to be 14.8. Thus, using the effect size of 0.57, adopting the level of significance of 0.05 and a power of 80%, and using a one-sided test for noninferiority study, it was reached the final number of 20 teeth per group, which results in 40 children in total.
Children aged 4–9 years old from public and private health systems from the cities of Manaus (AM, Brazil) and Uberlândia (MG, Brazil) were invited to participate in the study between June and December 2017. The screening was performed using a mouth mirror, a WHO probe, and cotton rolls, by three examiners previously trained and calibrated for the caries diagnosis.
Children in good general health and cooperative to the exam, with at least one primary carious molar with a medium or shallow lesion on occlusal surfaces, were included in the study. Exclusion criteria included teeth with pulp exposure, spontaneous pain, mobility, swelling or fistula next to the tooth, furcation or cervical lesion, and teeth with restorations, sealants or enamel defects.
Random allocation and allocation concealment mechanism
Teeth included were distributed in two parallel groups: (ART Group) and Chemicomechanical Removal Group with Papacarie® gel (Papacarie® Group). Teeth were randomly assigned according to a sequence of random numbers (MedCalc Statistical Software version 15.8, Ostend, Belgium) in blocks of 4 and 6, distributed in opaque and sealed envelopes by an external researcher. The operator only became aware of the technique to be used at the time of execution.
The operators and participants were not blinded due to the evident difference between the techniques. However, the examiner and the researcher responsible for the statistical analyses were blinded.
For the ART group, selective removal of carious dentin was performed. Both infected and affected dentin were removed from the cavity surrounding walls, but only the infected dentin was removed from the pulp wall using manual instruments.
For the Papacarie® group, the manufacturer's instructions were rigorously followed. The gel was left in the cavity for 40 s, followed by removal of carious tissue without manual pressure, with the inactive part of the manual instrument. Upon affected tissue removal, the cavity was washed out and dried.
In both techniques, the teeth were restored using restorative glass ionomer cement (Riva Self Cure; SDI, Victoria, AUS).
Three previously trained operators performed the restorative procedures. Training was done by lecture classes, and laboratory practice carried out by an clinical expert in both techniques.
The primary outcome was pain reported by the Wong-Baker Faces Pain Rating Scale. This scale was presented to patients immediately after the procedure. An external researcher asked the following question: What did you feel during the treatment? Then, the patient was asked to point at the illustration that best matched their pain perception.
The secondary outcome was patient's heart rate and peripheral oxygen saturation during caries removal. Thus, before the restorative procedure, baseline heart rate and pulse oximetry were operator recorded. With the oximeter in place, a stopwatch was triggered at the start of the randomized operative technique and interrupted only at the end of the infected dentin removal procedure. Oximetry and heart rate values were monitored and recorded throughout the removal process to assess changes in readings.
An external researcher measured the time spent in the intervention in minutes.
Data analysis was performed considering the tooth as the unit of analysis.
Poisson regression analysis was used to compare both groups and to assess the influence of explanatory variables on pain perception of children (treatment group, first attendance at dental office, anesthesia, children's cooperation reported by the dentist, and time spent in the intervention).
Initially, an unadjusted Poisson regression analysis was performed for each explanatory variable. Subsequently, we performed an adjusted Poisson regression model with variables that showed P < 0.20. In the final model, only variables that showed P < 0.05 remained in the analysis. Prevalence ratios were calculated with 95% confidence interval (CI).
A one-way ANOVA was conducted to compare time spent in intervention, heart rate, and peripheral oxygen saturation during restorative treatment.
Significance level was set at 5%, and CI (95%) was calculated. All analyses were performed in Statistical Package for the Social Sciences® (SPSS) software, version 20.0 (IBM Corp., Armonk, New York, USA).
| Results|| |
One hundred and forty-one children were screened from June 2017 to October 2017. Of those, 40 children were recruited and randomly allocated in two groups. [Figure 1] displays the recruitment process.
[Table 1] presents the characteristics of included participants. Most children were female (61%), between 6 and 7 years old (79%), with high caries experience (77%). In the ART group, 55% of patients reported the absence of pain during the procedure, 40% reported mild pain, and only 5% reported moderate pain. In the Papacarie® Group, 55% reported no pain, 40% reported mild pain and 5% reported intolerable pain.
Results of Poisson regression analysis are shown in [Table 2]. Unadjusted analysis showed only children's cooperation was associated with pain perception. For this reason, adjusted analysis was not conducted, and only this variable was maintained in the final model. Cooperative participants reported lower pain compared to those that showed no cooperation (0.188; 95%: 0.056–0.628).
|Table 2: Poisson regression analysis between pain perception reported by children and independent variables|
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[Table 3] reports the results of secondary outcomes. No statistically significant differences between the groups regarding time spent on restorative procedures and oxygen saturation during treatment were observed. However, chemomechanical caries removal resulted in statistically significant lower heart rate compared to ART (P = 0.013).
|Table 3: Mean and standard deviation of oxygen saturation, heart frequency, and the time of intervention for experimental groups|
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| Discussion|| |
The sensation of thermal effects resulting from pressure on the pulp, perception of sensitivity related to the heating of the pulp chamber, and the vibration and noises derived from the rotating instruments often generate dental fear and anxiety, leading patients to avoid dental care., Therefore, several carious tissue removal methods, such as those studied herein, are tested for broader acceptance of procedures among infants. We observed no statistically significant differences between ART and Papacárie® groups concerning pain perception during caries removal. However, children in the Papacárie® group showed lower heart rate compared to the ART group.
A previous systematic review has shown that the use of rotatory instruments and local anesthesia are the main reasons for pain and anxiety during restorative procedures in children. In both techniques tested in the present study, we did not use these steps, which can explain the similar findings regarding patient-reported outcome.
Furthermore, both ART and chemomechanical are based on minimally invasive dentistry philosophy, aiming at minimal removal of dental tissue. ART has been shown to be effective in the management of cavitated caries lesion.,,,, Conversely, chemomechanical removal, which uses chemicals to remove softened carious tissue with blunt manual noncut manual instruments, has been recommended for patients with special needs, phobic infants and adults, since it would not cause pain, produce noise, or create other inconveniences to patients., However, the advantages of this technique are still questionable, this could result in a longer and expensive procedure, without any additional benefits. Although, in theory, chemomechanical removal would be more comfortable and less traumatic to patients because it only removes nonremineralize carious tissue., Our study refuted this hypothesis.
Our results, nonetheless, differ from previous studies. Abdul Khalek et al. stated that the group treated with gel showed a lower index of pain and discomfort; however, the procedure took, on average, 1 min longer than ART. Moreover, the systematic review and meta-analysis performed by Deng et al. analyzed several outcomes, including the pain perception according to the Wong-Baker Scale. The author found reduced pain perception when the gel was used; however, the Papacárie® technique was compared to conventional removal using a rotating instrument. It is also important to highlight that most published studies did not consider the pain perception among patients as a primary outcome; hence, these results need to be considered cautiously.
On the other hand, dental anxiety in children is frequently associated with previous negative experiences. Previous study has, however, showed that previous visits to the dentists is associated with lower anxiety levels in preschool children. These data differ from our study, which to be a first attendance at dental office was not associated with pain perception. A possible explanation has been earlier explored by authors which justified that dental pain experienced is a better predictor of dental anxiety than the fact of has or has not previously visited the dentist.
However, it is important to highlight that the sample included in this study had a low caries experience. Thus, there is a possibility that the participants have never experienced previous invasive interventions, being this possible limitation of our study. The lack of association between the first dental office attendance with pain perception could be different in other populations. Thus, the extrapolation of the results should be considered with caution. Further studies comparing both techniques as the first intervention could help to provide more evidence in the benefits of using both techniques.
One obstacle to assessing pain in infants is the misperception that they do not know how to express themselves. However, several methods to measure pain and discomfort with the use of scales such as the Wong-Baker Faces Pain Rating Scale, which consists of a series of faces with different expressions ranging from “no hurt” to “hurts worst” have been proposed and validated. For this reason, we opted to use this tool to measure the pain perception of the children. Another way of measuring the pain felt by newborns and infants is by evaluating physiological variables using a finger pulse oximeter, which allows reading of heart rate and oxygen saturation during dental procedures. However, patient-reported outcomes have been suggested as the most important variable to be considered, especially in evidence-based dentistry.
Thus, even though chemomechanical removal could reduce pain perception of the restorative procedure by children, dentists do not widely use it. The reduction of pain perception in children is particularly important to dental anxiety and behavior management during dental care. For this reason, both ART and chemomechanical removal could be used in caries lesion treatment of primary teeth to improve the dentist–patient relationship.
| Conclusion|| |
Children that underwent chemomechanical caries removal presented lower heart rate compared to those who underwent ART. However, both techniques showed minimal or absent perceived pain.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]
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