INTRODUCTION
Globally, dental caries is the most prevalent pediatric disease.1 The World Health Organization (WHO) estimates that dental caries affect 60–90% of school-age children, mostly in underdeveloped nations.2 While rotary devices can remove caries relatively quickly, there is a risk of damaging tooth structure and overheating the pulp or nerves, which can result in excruciating pain.3 While local anesthetics may lessen pain, young children may become more fearful of needles and less cooperative during restorative treatments due to the noise and vibration of rotary devices.4
The two most important factors in pediatric dentistry are dental treatment-related anxiety and discomfort.5 Anxiety and pain are strongly associated with more intrusive restorative dental treatments for children, according to a systematic study that concentrated on patient-reported outcomes.6 Patients delay seeking care because of the fear associated with rotary devices.7
Dental caries can be managed using various techniques, such as chemo-mechanical removal and atraumatic restorative treatment (ART). The ability to remove only the caries-infected tissue while leaving the caries-affected tissue intact is a common characteristic of these techniques.8 In ART, hand instruments are used to remove soft and demineralized carious tissue, which is then conditioned and restored using an adhesive substance.9 Because ART doesn't require rotary instruments, rubber dams, or local anesthetics, it produces less pain.9 As a result, it's regarded as a patient-friendly procedure. Even though ART is considered to be a non-traumatic therapy, a systematic review found no evidence that it lowers patient anxiety when compared to traditional treatments.10
Due to the simplicity of the removal of carious tissue, chemo-mechanical caries removal (CMCR) has been proposed as a substitute to reduce patient concern.11 This method, when combined with hand instruments, allows for the minimally invasive removal of contaminated carious tissue by dissolving it with a chemical agent.12 One of the main benefits of CMCR is that it only removes the infected layer of dentin, preserving more dental tissue and preventing pulpal tissue irritation. It can be used on uncooperative children and patients who are physically disabled or who have infectious diseases.13
In recent years, minimally invasive dentistry (MID) has become central to modern pediatric dental care, focusing on conserving tooth structure and ensuring a more comfortable experience for children. Despite this positive shift, there is still limited analytical evidence14-17 directly comparing how various minimally invasive techniques—such as CMCR and ART—affect children’s perception of pain during treatment. Gaining clearer insights into this aspect can help clinicians choose techniques that not only preserve teeth but also make dental visits less stressful for young patients. Hence, the aim of this systematic review is to assess and compare the efficacy of CMCR and ART on pain reaction among children.
MATERIALS AND METHODS
The systematic review procedure was con-ducted by the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines.18
Study registration
The protocol and study details have been registered in PROSPERO. (Registration number: CRD42024565077).
Focused question
Is there a difference in the effect of CMCR and ART on pain reaction among children?
PICO analysis:
Population: Children; Intervention: Chemo-mechanical caries removal; Comparator: Atraumatic restorative treatment; Outcome: Pain reaction
Search strategy
To locate relevant papers, a thorough search was conducted across databases like PubMed, Cochrane, Scopus, Lilacs, Science Direct, Web of Science, EBSCOhost, and Google Scholar (first 100 hits screened) from the earliest date available until July 15, 2024. A manual search of scholarly journals, conference proceedings, unpublished articles, and cross-references was done to find further publications. The search strategies for the above-mentioned data-bases have been summarized in Table 1.
Table 1. Search strategies for the various databases used in this study
| Database | Search string |
|---|---|
| PubMed | ((chemo mechanical caries removal OR papain) AND dental atraumatic restorative treatment) AND (pain OR pain measurement OR pain perception OR patient comfort) AND (child OR primary molar |
| Cochrane Library | ("chemo mechanical caries removal" OR "papain") AND "dental atraumatic restorative treatment" AND ("pain" OR "pain measurement" OR "pain perception" OR "patient comfort")AND ("child" OR "primary molar") |
| Scopus | (TITLE-ABS-KEY("chemo mechanical caries removal" OR "papain") AND TITLE-ABS-KEY ("dental atraumatic restorative treatment") AND (TITLE-ABS-KEY("pain") OR TITLE-ABS-KEY ("pain measurement") OR TITLE-ABS-KEY("pain perception") OR TITLE-ABS-KEY ("patient comfort")) AND (TITLE-ABS-KEY("child") OR TITLE-ABS-KEY("primary molar"))) |
| Lilacs | ((chemo mechanical caries removal OR papain) AND dental atraumatic restorative treatment) AND (pain OR pain measurement OR pain perception OR patient comfort) AND (child OR primary molar) |
| ScienceDirect | ("chemo mechanical caries removal" OR "papain") AND "dental atraumatic restorative treatment" AND ("pain" OR "pain measurement" OR "pain perception" OR "patient comfort") AND ("child" OR "primary molar") |
| Web of Science | ("chemo mechanical caries removal" OR "papain") AND ("dental atraumatic restorative treatment") AND ("pain" OR "pain measurement" OR "pain perception") OR "patient comfort")) AND ("child" OR "primary molar")) |
| EBSCO Host | ((chemo mechanical caries removal OR papain) AND dental atraumatic restorative treatment) AND (pain OR pain measurement OR pain perception OR patient comfort) AND (child OR primary molar) |
| Google Scholar | "chemo mechanical caries removal" OR "papain" AND "dental atraumatic restorative treatment" AND ("pain" OR "pain measurement" OR "pain perception" OR "patient comfort") AND ("child" OR "primary molar") |
Inclusion criteria
Exclusion criteria
Screening and selection
The reviewers (SM and RM) examined the study titles separately. Duplication resulted in the omission of articles from different databases. If the search terms appeared in the article title, it was considered eligible for abstract reading. If the abstracts supported the aim of the study, the papers were considered for full-text reading. Their eligibility was assessed after the full-text data were obtained. If the articles satisfied the eligibility requirements, they were processed further for data extraction (Figure 1). The reference lists of the full-text papers were manually searched to locate additional research. Discussions were used to settle disagreements.
Data extraction
The following information was gathered and put into an Excel spreadsheet (MS Excel 2020) by two reviewers: author details, study year, study location, study design, participant demographics, pain assessment scale, intervention, outcome, and inference of the included studies. Publications written in other languages were translated into English using Google Translate.19 When full-text publications were unavailable, the pertinent authors were contacted to obtain the missing text or other information. To maintain consistency, both reviewers (SM and RM) first carried out a calibration exercise on a subset of studies. Any differences in their screening or data extraction were discussed and resolved by consensus, and the criteria were refined to ensure uniform application throughout the review.
Risk of bias assessment
The Cochrane risk-of-bias tool for randomized trials Version 2 (RoB 2) was used to evaluate the risk of bias for randomized controlled trials.20 Random sequence generation, allocation concealment, participant and personnel blinding, outcome assessment blinding, insufficient outcome data, selective reporting, and other biases were the criteria utilized to evaluate the bias. There were three categories for overall bias risk: low, high, and uncertain.
The risk of bias in clinical comparative studies was evaluated using the ROBINS-I (Risk of Bias In Non-randomised Studies - of Interventions Tool).21 The following criteria were applied to evaluate the bias: confounding bias, participant selection bias, intervention classification bias, deviation from intended interventions bias, missing data bias, outcome measurement bias, and reported result selection bias. There were four categories for overall bias risk: low, moderate, serious, and critical.
Quality of evidence
The strength of evidence in the included studies was evaluated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) tool.22 This framework classifies evidence into four levels—very low, low, moderate, and high. Each study was carefully assessed across the key GRADE domains, including risk of bias, consistency of results, indirectness, imprecision, and potential publication bias, to determine its overall quality.
Data analysis
After entering the obtained data in the data extraction table for the qualitative synthesis, the meta-analysis was conducted for the quantitative synthesis. The difference in outcome between the chemo-mechanical and ART groups was evaluated using a random-effect model. To estimate the odds ratio (OR) at a 95% confidence interval (CI), the total number of events in each group with positive pain scores was used. The heterogeneity in the findings of the included studies was evaluated using the I2 statistic and Chisquare tests. For statistical significance, heterogeneity was defined as a p-value less than 0.1. Review Manager version 5.4.1 was used to conduct the statistical analysis.
RESULT
Search and selection results
Using PubMed, Scopus, EBSCOhost, Web of Science, Science Direct, Lilacs, Cochrane databases, Google Scholar, and manual searching, 664 articles were found. 650 titles were assessed once the search was cleared of duplicates. After reading the titles, 15 articles were selected. Following the evaluation of the abstract, ten articles were removed. Five23-27 full-text publications were processed for data extraction. The characteristics of the included studies have been presented in Table 2.
Table 2. Characteristics of included studies
| Author, Year of study | Place of study | Type of study | Participant description (Sample size, age, gender) | Pain assessment scale | Intervention | Outcome | Inference |
|---|---|---|---|---|---|---|---|
| Satie et al,22 (2011) | Brazil | Split-mouth, randomized controlled trial | Total participants=8 children. Age=3-6 years | Wong-Baker Faces Pain Rating Scale (WBS) | Group 1= 8 primary molars ART Group 2=8 primary molars Chemo-mechanical caries removal The cavities were restored with GIC | Chemo-mechanical group No pain=100% ART No pain=100% | No difference in pain perception between the groups |
| Khalek et al,23 (2017) | Egypt | Parallel-arm, randomized controlled trial | Total participants =50 children Age=4-8 years | Sound, Eye, and Motor (SEM) scale | Group 1=25 participants Chemo-mechanical caries removal Group 2=25 participants ART The cavities were restored with chemically cured GIC | Chemo-mechanical group Median S score=1 (comfort), Median E score=1 (comfort), Median M score=1 (comfort). Adjusted mean SEM score=3.6 Mean time for caries removal=5.8 min. ART Median S score=3 (moderately painful) Median E score=2 (mild discomfort), Median M score=3 (moderately painful). Adjusted mean SEM score=7.8 p-value=0.001 Mean time for caries removal=4.8 min | Chemo-mechanical caries removal is associated with minimal is pain compared to ART. However, the working time for chemo-mechanical caries removal is more |
| Pascareli-Carlos et al,24 (2021) | Brazil | Parallelarm, randomized controlled trial | Total participants=40 children. Age=4-9 years | Wong-Baker Faces Pain Rating Scale (WBS) | Group 1= 20 participants Chemo-mechanical caries removal. Group 2=20 participants. ART The cavities were restored with GIC | Chemo-mechanical ART group. No pain=55%, Mild pain=40%, ART Moderate pain=5%. Working time for chemo-mechanical removal 8.4 min. Working time for ART 9.2 min | No statistical difference in pain perception beween the groups. No statistical difference in the working time between the groups |
| Gupta et al,25 (2022) | India | Split-mouth clinical comparative study | Total participants=40 children. Age=4-10 years | Wong-Baker Faces Pain Rating Scale (WBS) | Group 1= 40 primary molars Chemo-mechanical removal. Group 2=40 primary molars. ART The cavities were restored with GIC | Chemo-mechanical group. Score 0=59.5%, Score 2=30%, Score 4=7.5%. ART Score 0=70%, Score 2=12.5%, Score 4=12.5%, p-value=0.147, Mild discomfort in ART group | No statistical between the groups |
| Ghanem et al,26 (2023) | Egypt | Randomized Controlled trial | Total participants=50 children. Age=5-8 years | Sound, Eye, and Motor (SEM) scale | Group 1= 25 participants Chemo-mechanical caries removal. Group 2=25 participants. ART The cavities were restored with resin modified GIC | Chemo-mechanical group. SEM score 1 =100%, SEM score 2=0%. ART SEM score 1=60%, SEM score 2=40%, p-value <0.001, Children showed more co-operative behavior (p=0.002) Working time for chemo-mechanical removal 9.5 min Working time for ART Working time for ART | Chemo-mechanical caries removal is associated with minimal pain compared to ART. However, the working time for chemo-mechanical caries removal is more |
Four studies23,25,27 were randomised controlled trials whereas, one was a clinical comparative study.26 A split-mouth design was used in two studies23,26 while a parallel design was used in three studies.24,25,27 Individuals (aged between 4 and 10 years) were included in the study. The sample size of the included studies ranged from 8 to 50.
Place of studyTwo studies were conducted in Brazil,23,25 two in Egypt,24,27 and one in India.26
Clinical indices
The Sound, Eye, and Motor (SEM) scale was used in two studies24,27 whereas, the Wong-Baker Faces Pain Rating Scale (WBS) was used in three studies.23,25,27
Intervention
In all the studies,23-27 papain was used as the CMCR agent for 1-3 mins (based on the manufacturer’s instructions) and ART was performed using hand instruments. Both the intervention and control groups were restored using GIC.
In the study conducted by Khalek et al.,23 and Ghanem et al.,27 the SEM scale was used by the assessors to gauge the child's response to cavity preparation and caries removal after seeing videos of caries removal sessions. The WBS was given to patients right after the treatment procedure in the study conducted by Pascareli-Carlos et al.,25 The best-fitting illustration for the patient's perceived pain was asked to be pointed at. In the study conducted by Satie et al.,23 the WBS was used to measure how a child reacted to pain during the treatment.
In the study conducted by Gupta et al.,26 WBS was presented to the patients immediately after the treatment and the patients were asked to select a face that best represented their level of pain.
Study outcomes
CMCR was associated with minimal pain compared to ART in two studies.24,27 In the study conducted by Khalek et al.,24 the adjusted mean SEM score for CMCR was 3.6 whereas for ART was 7.8. In the study conducted by Ghanem et al.,27 100% of the participants had a SEM score of 1 (comfort) for CMCR whereas, for ART it was 60%. No statistically significant difference was found between CMCR and ART in three studies.23,25,26
The working time for CMCR and ART was assessed in three studies. The working time for CMCR was 5.8, 8.4, and 9.5 mins whereas for ART it was 4.8, 9.2, and 5.7 min in the studies conducted by Khalek et al.,24 Pascareli-Carlos et al.,25 and Ghanem et al.27
Risk of bias assessment
In RCTs, three studies24,25,27 were rated as low risk of bias whereas, one23 was rated as unclear risk of bias. The study was rated as unclear risk of bias because details regarding allocation concealment, blinding of participants and personnel, and blinding of the outcome assessment were not mentioned. The risk of bias summary has been illustrated in Figure 2A. Random sequence generation, incomplete outcome data, reporting bias, and other bias exhibited a low risk of bias of 100%. Allocation concealment, blinding of participants and personnel, and blinding of outcome assessment exhibited a low risk of bias of 75%. The risk of bias graph has been illustrated in Figure 2B. For the clinical comparative study, the overall risk of bias was low, (Table 3).
Table 3. Risk of bias assessment in non-RCT using the RoB-I Tool
| Study | Domain | Gupta et al |
|---|---|---|
| Gupta et al,25 (2022) | Bias due to confounding | No |
| Bias in selection of participants | No | |
| Bias in classification of interventions | No | |
| Bias due to deviation from intended interventions | No | |
| Bias due to missing data | No | |
| Bias in measurement of outcomes | No | |
| Bias in the selection of reported result | No | |
| Judgement | Low |
Quality of evidence
The evidence's quality was determined to be "high," indicating that the true effect is close to the estimate of the effect. (Table 4).
Table 4. Quality of evidence as assessed by the GRADE Tool
| Certainty assessment | № of patients | Effect | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of Study | Study design | Risk of bias | Incon- sistency | Indirect- ness | Impre- cision | Other conside- rations | CMCR | ART | Relative(95% CI) | Absolute(95% CI) | Quality of the Evidence(GRADE) | ||
| 5 | Randomised and non-randomised trials | Serious | Not Serious | Serious | Not Serious | None | 25/118 (21.2%) | 56/118 (47.5%) | OR 0.12 (0.01 to 1.68) | 377 per 1000 (from 466 fewer to 128 more) | ⊕⊕⊗⊕ High | ||
Synthesis of result
A high statistical heterogeneity was found between the studies; Test for heterogeneity: p<0.00001; I2=89% (Figure 3).
Sub-group analysis
A subgroup analysis of RCTs showed that there was no significant difference in pain scores between CMCR and ART (OR: 0.03 [95% CI: 0.00–3.24]; p = 0.14). However, the findings within this subgroup were highly inconsistent, as indicated by the high heterogeneity I2 = 90%, p< 0.0001; suggesting substantial variation among the included studies (Figure 4A).
When pain was measured using the Wong–Baker Faces Pain Scale (WBS), the results were more consistent, again showing no significant difference between CMCR and ART (OR: 1.33 [95% CI: 0.63–2.79];p = 0.45). In this subgroup, heterogeneity was low (I2 p= 0%, 0.58), indicating that the studies were largely in agreement (Figure 4B).
In contrast, studies that used the Sound, Eye, and Motor (SEM) scale found that CMCR was associated with significantly lower pain compared to ART (OR: 0.00 [95% CI: 0.00–0.29]). Although these results favored CMCR, moderate heterogeneity was observed (I² = 67%, p= 0.08), suggesting some variation in the study outcomes (Figure 4C).
DISCUSIÓN
Dental caries is a prevalent disease that affects people of all ages. A biological and less intrusive method has become more important in the management of carious lesions. Therefore, eliminating infected dentin without sacrificing healthy dentin—which can remineralize— has been the ultimate objective of conservative restorative dentistry.
In this review, two studies24,27 suggested that CMCR was associated with minimal pain compared to ART, whereas three studies23,25,26 suggested that no statistically significant difference was found between the two groups. A quantitative synthesis of the included studies revealed a high heterogeneity between the studies thus making it difficult to make a conclusion (p<0.00001; I2=89%). A sub-group analysis of RCTs suggested no difference in the scores between CMCR and ART with high heterogeneity (p<0.0001; I2=90%). A sub-group analysis of patients whose pain score was recorded using the WBS also suggested that there is no difference in the scores between CMCR and ART with no heterogeneity (p=0.58; I2=0%).
However, this finding should be interpreted with caution, as it is drawn from only three studies, which limits how confidently the results can be generalized. A sub-group analysis of patients whose pain score was recorded using the SEM scale suggested that CMCR was associated with minimal pain compared to ART with moderate heterogeneity (p=0.08; I2=67%).
Since 1975, several CMCR agents have been produced. They fall into one of two broad categories: agents based on enzymes or agents based on sodium hypochlorite (NaClO).28 All the studies in this review used papain as the CMCR agent. Papain is an enzyme-based agent that is considered an effective chemical debriding agent. It is a cysteine protease obtained from green papaya (Carica papaya) fruits and latex.29 It is believed to function by breaking down partially degraded collagen molecules and assisting in the removal and disintegration of the fibrin mantle produced by the carious process without damaging the intact collagen fibrils.28 This leads to a softening of the diseased dentin, which can be removed with non-cutting instruments and without anesthesia.
Dorri et al.,30 found that children reported less pain with ART compared to traditional cavity preparation. Deng et al.,31 similarly showed that papain-based CMCR techniques caused less discomfort than conventional methods. In addition, da Silva et al.,32 reported that using CMCR together with ART reduced pain even more effectively than ART alone. Despite these insights, no systematic review has directly compared CMCR and ART in terms of pain reduction. This makes the present review the first to specifically explore this comparison.
The working time of CMCR was found to be higher than that of ART. This could be explained by the fact that the study's lesions were accessible with hand instruments and ART; in contrast, caries was removed chemo-mechanically by using the CMCR agent multiple times. However, according to a systematic study by Hamama et al.,29 CMCR had a higher excavation time than rotary instruments but somewhat less than ART (mean working time for CMCR, rotary instruments, ART= 6.36, 2.99, and 6.98 min respectively). The difference in the findings of the current systematic review and the aforementioned systematic review could be due to variation in the age of the individuals, types of lesions, and accessibility.
Based on the pain assessment scales used, it was observed that while studies using the WBS supported neither treatment, those utilizing the SEM scale concluded that CMCR is superior to ART in producing the least amount of pain. Pain is a subjective experience. The WBS evaluates a child's perception of pain. The inherent dread and apprehension associated with the operation or dentist appointment may make this scale erroneous or untrustworthy. The SEM scale obscures the confounding variables connected to the child's sense of pain and suffering by concentrating on the auditory, visual, and motor alterations as noted by the dentist.33 Hence, the nature of the scale used to assess the pain reaction plays a significant role in deciding the outcome of the intervention.
Limitations
This review has a few important limitations to consider. First, only a small number of studies directly compared CMCR and ART. Subgroup analysis using WBS showed no heterogeneity. However, it was based on just three studies, which limits how confidently the results can be interpreted. Second, considerable heterogeneity was seen in the other subgroup analyses, possibly because of differences in participant age and operator experience. Third, the way minimally invasive techniques were carried out varied across studies, and the lack of a consistent method for measuring pain may have influenced the findings.
Finally, many of the included studies had relatively small sample sizes and showed an unclear risk of bias, particularly in blinding and outcome assessment. Moreover, formal assessment of publication bias could not be performed due to the small number of included studies.
Future recommendations
Studies using a combination of both subjective and objective pain assessment scales may be helpful in determining the true pain reaction and provide more conclusive evidence of pain perception for a particular intervention. This would further substantiate the efficacy of CMCR and ART in terms of pain reaction. A finger pulse oximeter,34 which measures heart rate and oxygen saturation during dental operations, can be used to evaluate physiological factors. Future studies are required to evaluate the effectiveness of these two minimally invasive restorative methods in real-world settings, particularly those with limited resources. These studies should also focus on children with special needs, children who struggle with behavior management, and children who have had unfavorable dental treatment experiences.
Large-scale multi-center trials need to be conducted in the future to get more valid results. Furthermore, the chemo-mechanical method of caries removal is not cost-effective in under-developed and developing countries due to the addition of the cost of chemical agents. Therefore, further studies need to be conducted to evaluate the feasibility and cost-effectiveness of the CMCR method.
CONCLUSIONS
The current review concludes that there is no difference in the effect of chemo-mechanical caries removal and atraumatic restorative treatment on pain reaction among children. However, the certainty is low due to high heterogeneity among the included studies. Further studies with a combination of subjective and objective scales may help determine the true pain reaction and provide more conclusive evidence for pain reaction to chemo-mechanical caries removal and atraumatic restorative treatment.
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AUTHORS’ CONTRIBUTIONS
Subhashree Mohapatra: Concept, design, and definition of intellectual content, literature search, data acquisition, data analysis, manuscript preparation. | Rahul Mohandas: Data acquisition, manuscript editing and manuscript review.
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