ORIGINAL RESEARCH |
https://doi.org/10.5005/jp-journals-10077-3282 |
Clinical Efficacy and Pain Perception with Novel Chemomechanical Caries Removal Agent and Conventional Method in Primary Molars: A Randomized Controlled Study
1–6Department of Pediatric and Preventive Dentistry, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth (Deemed to be University), Vadodara, Gujarat, India
Corresponding Author: Seema Bargale, Department of Pediatric and Preventive Dentistry, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth (Deemed to be University), Vadodara, Gujarat, India, Phone: +91 9586115657, e-mail: drseemabargale@gmail.com
Received: 13 June 2023; Accepted: 11 July 2023; Published on: 30 December 2023
ABSTRACT
Background: Conventional means of preparing cavities include the use of high-speed handpieces and slow-rotating instruments, following the philosophy of extension for prevention. This method usually induces pain, annoying sounds, and vibration. Thus, chemomechanical caries removal (CMCR) has been developed to be an alternative. It involves the application of proteolytic substances, which softens the carious dental tissue and facilitates its removal manually. BRIX3000 is a newer agent with upgraded properties that has been used for efficient caries removal.
Aim: To evaluate and compare clinical efficacy and pain perception with a new CMCR agent (BRIX3000) and conventional caries removal method.
Materials and methods: A total of 60 children aged between 4 and 9 years were allotted to the CMCR (BRIX3000) and rotary caries removal groups. Clinical efficacy and the Wong–Baker Pain Rating Scale (WBPRS) were used as the two parameters. The obtained data analysis was done using an independent t-test and Mann–Whitney U test.
Results: Comparison of the difference in clinical efficacy showed a statistically significant difference in the CMCR (BRIX3000) group with a mean value of 2.33 ± 1.03 as compared to the rotary caries removal group with a mean value of 0.57 ± 0.68 with a p-value of <0.001. In WBPRS, the rotary caries removal group (mean: 4.6 ± 1.83) showed an increased score in comparison with the CMCR group (mean: 1.47 ± 1.17) with a p-value of <0.001.
Conclusion: Chemomechanical caries removal (CMCR) group (BRIX3000) showed increased clinical efficacy as compared to rotary caries removal group. The rotary caries removal group showed increased WBPRS scores.
Clinical significance: The use of the CMCR method in pediatric dentistry can prove to be very beneficial, especially in terms of anxiety and discomfort felt by the children.
HOW TO CITE THIS ARTICLE
Bargale S, Jain S, Deshpande AN, et al. Clinical Efficacy and Pain Perception with Novel Chemomechanical Caries Removal Agent and Conventional Method in Primary Molars: A Randomized Controlled Study. J South Asian Assoc Pediatr Dent 2023;6(3):124–128.
Source of support: Nil
Conflict of interest: None
Keywords: BRIX3000, Chemomechanical caries removal, Primary teeth
INTRODUCTION
In spite of the substantial reduction in caries prevalence in developed countries, it continues to be widespread across the globe. Once a carious lesion starts to form, it becomes very important to use the most conservative way to prevent lesion progression and, at the same time, minimize the loss of unaffected tooth structure.1
Traditionally, caries excavation had been performed using rotary instruments, leading to overly extended cavities, unnecessary healthy tissue removal, heat and pressure on pulp, pain stimulus, and the need for using local anesthesia.2 Gradual evolution of techniques that remove caries has changed the basis of cavity preparation in numerous ways in the last two centuries.3
The principle behind minimal invasive restorative dentistry dictates the removal of carious lesions effectively, along with maximum protection of healthy tooth structure and pulp vitality.4 Chemomechanical caries removal (CMCR) is one such technique that efficaciously removes infected dentin by the use of a chemical agent. The CMCR method has a high acceptance rate, especially among children with dental anxiety.5 It selectively removes the infected tissues, avoiding harm to sound dental structure and pulp, along with negating patient discomfort.6
Chemomechanical caries removal (CMCR) was introduced in 1972, and GK-101 was marketed, although because of its aggressive consequence on both carious lesion and sound structures, a search for a newer material led to the development of Caridex in 1984, which was less degrading to healthy tissues.7 In 2003, another agent derived from the papaya peel was presented (papacarie); its important component was papain, which is comparable to the human pepsin enzyme. It denatures collagen fibers, resulting in easy caries removal using an excavator instrument, and chloramine chemically softens the carious part of dentin and provides antimicrobial action.8
The newest modification in the array of papain-based CMCR gels is BRIX3000 from Argentina.9 The papain concentration in BRIX3000 is 3000 U/mg per 10%, which is bio-encapsulated using encapsulated buffer emulsion (EBE) technology. This modification maintains the ideal pH of the gel, which is needed for immobilizing enzymes, which results in more efficient collagen proteolysis, enhanced resistance to unfavorable storage environments, and better antimicrobial properties.10 Furthermore, BRIX3000 does not contain chloramines, which helps in enhanced toxicological safety.11
The CMCR and conventional caries removal methods need to be evaluated when used clinically. The methods used for evaluating the clinical efficacy are by evaluating the amount of remaining caries by scores (0–5) given by Ericson.12 Additionally, there are scales that help assess the dental pain in patients through their perception. One such scale is the Wong–Baker Faces Pain Rating Scale (WBPRS). WBPRS presents six faces that portray increasing degrees of pain. Each face is attributed a score from 0 to 10, indicated on the scale.13 This study is intended to evaluate and compare the clinical efficacy and pain perception of the new CMCR agent (BRIX3000) with a conventional airotor used for caries removal in primary molars.
MATERIALS AND METHODS
This study was performed in the Department of Pediatric and Preventive Dentistry. Ethical clearance was obtained from the Institutional Ethical Committee (SVIEC/ON/DENT/RP/22005) and has been registered under the clinical trials registry India (CTRI/2022/07/043848), and the study period was from March 2022 to January 2023.
Sample Size Description
The sample size had been estimated to be 30 per group, using 1% α error, 80% power, and a clinically significant difference of 1 unit. The total sample size was decided to be 60 participants.
Inclusion Criteria
- Children between 4 and 9 years of age.
- Children having occlusal caries on mandibular and/or maxillary either first or second primary molars.
- The teeth should belong to code 1.2 according to the Mount and Hume classification.
- The child patient whose parents gave the written informed consent.
Exclusion Criteria
- Children suffering from any illness requiring special medical care.
- Children having teeth with pulpal exposure, mobility, spontaneous pain, swelling or fistula next to the tooth, furcation or cervical lesion, and teeth with sealants, restorations, or enamel defects.
PROCEDURE
The study design was a double-blinded, randomized control study. The written consent was obtained from the participant’s parents or caregiver after giving the participant’s parents an information sheet.
Participants were segregated into two different groups, with 30 children in each group using a computer-generated randomization program. The coinvestigator kept a record of it separately and proceeded with the treatment of the allotted group while the principal investigator performed the evaluation after every treatment. The principal investigator and the statistician were blinded in this study.
The child patient and parents were explained about the entire procedure. All the instruments were sterilized according to standardized protocols.
BRIX3000 (Group I)
BRIX3000 (Brix SRL, Argentina) (Fig. 1) was utilized. The manufacturer’s instructions were followed for the material application. BRIX3000 was placed into the carious lesion using a blunt spoon excavator for two minutes. Initially, the BRIX gel remained clear; however, later, because of its effect, it turned darker in color (turbid) (Fig. 2). The softened infected dentin was scraped away in pendulum motion without using pressure. If needed, the procedure was performed again until the gel remained clear.
Fig. 1: BRIX3000 (Brix SRL, Argentina)
Fig. 2: Application of BRIX3000 (group I)
Conventional Method (Group II)
Airotor with a round bur (BR41) was used for selected carious teeth to remove decayed dentin (Fig. 3).
Fig. 3: Conventional method (group II)
All the teeth in the study were restored with Glass Ionomer Cement (GC Gold label 9, GC Corporation Tokyo, Japan) restorative material.
Evaluation Criteria
The evaluation of CMCR and conventional caries removal method was performed by assessing clinical efficacy and using the WBPRS for pain perception.
Clinical Efficacy
The extent of remaining caries after the procedure was checked and marked by the following scores given by Ericson.12 Score 0: caries have been removed completely; score 1: caries still present in the base of the cavity; score 2: caries still present in base and/or wall; score 3: caries still present in base and/or two walls; score 4: caries still present in base and/or >2 walls; score 5: caries present in base, walls, and margins of the cavity.
Pain Perception
Wong–Baker Pain Rating Scale (WBPRS) was utilized. Children chose the face that they could relate to describe their own pain. Face 0, depicted that it does not hurt at all; face 2, depicted that it hurts just a little bit; face 4, depicted that it hurts a little more; face 6: depicted that it hurts even more; face 8: depicted that it hurts a whole lot, and face 10, depicted that it hurts as much as you can imagine.
Statistical Analysis
It was analyzed through IBM Statistical Package for the Social Sciences (SPSS) software (SPSS version 20.0; SPSS Inc., Chicago, Illinois, United States of America). Intergroup comparison was done using the independent t-test and Mann–Whitney U test.
RESULTS
A comparison of age between both groups showed that the mean age is higher in group I (BRIX3000) (6.23 ± 1.46) as compared to group II (conventional method) (6 ± 1.34).
In Figure 4, the mean clinical efficacy values in both groups were obtained, and it was found that the clinical efficacy was higher in group I (BRIX3000) with a mean value of 2.33 ± 1.03 than in group II (conventional method) (0.57 ± 0.68).
Fig. 1: Clinical efficacy scores in the BRIX3000 (group I) and conventional method (group II)
In Figure 5, the mean values of the scores from the WBPRS, which portrayed the pain perception, were obtained, and the WBPRS score for group II (conventional method) was higher with a mean value of 4.6 ± 1.83 when compared to group I (BRIX3000) (1.47 ± 1.17).
Fig. 5: Wong–Baker faces pain scale scores in BRIX3000 (group I) and conventional method (group II)
DISCUSSION
One of the common pathologies that affect people of all ages is dental caries. There are several different restoration techniques that can be implemented to cure carious lesions. Ranging from very invasive airotor drilling to minimally invasive chemomechanical techniques.
Conventional airotor is the most regularly used device in carious structure removal; however, it generates discomfort and pain along with instilling anxiety and fear in child patients.14 The importance of caries management has shifted toward a more biological as well as less invasive approach.
The CMCR technique is desirable since it offers a minimally invasive method. This system also eradicates anesthesia usage and painful symptoms, along with needless removal of healthy tooth structure, as only infected dentin is scooped.15
The most recent upgrade observed in the papain-gel category is the BRIX3000. It has a superior enzymatic activity when compared to other CMCR agents. Papain, being a crucial component, aids in faster and more efficient degradation of collagen without the use of any special armamentarium.16
In this study, pain perception was evaluated in 4–9-year-olds because a child undergoes the concrete development stage in cognitive behavior, and self-assessment of pain is common among this age group. Hence, the reliability of the study’s intervention was properly assessed using WBFPS.17 A study by Gupta18 observed that BRIX 3000® acted efficiently in removing caries and showed to be a promising and effective treatment option for child patients, which is in accordance with our study.
According to a study by Oommen,19 CMCR methods can be subjected as an alternative for caries removal when it comes to dental fear among patients associated with the noise of drilling and associated discomfort. The results showed that little pain response was observed while using a chemomechanical gel, which might be because of papain present in BRIX3000 gel, which works exclusively on dead infected cells, leaving behind unharmed healthy tissue. Papain has a debriding anti-inflammatory impact in contrast to the airotor caries removal group, where the operator uses the airotor against the hard dentin, hence harming more dentinal tubules that cause discomfort.12,20 Abdul21 stated that CMCR encompasses less pain compared to atraumatic restorative treatment (ART).
Pascareli-Carlos,22 in his study, agreed with a similar finding that participants who underwent CMCR showed lower pulse rate compared to ART. However, both techniques portrayed minimal perceived pain. On the contrary, Adham23 obtained results where patients complained of increased discomfort upon using the CMCR method compared to ART.
Rajakumar3 conducted a study that evaluated and compared the efficacy of the CMCR method using carie care with hand and rotary excavation by evaluating the time taken, pain response, and residual caries left. Their results portrayed that more time was taken in the caries care group than the airotor group and hand excavation group, efficacy was more with airotor, followed by carie-care, and least for manual excavation, the pain experienced was more with airotor followed by manual excavation and least of all is caries care. In the present study, the clinical efficacy of BRIX3000 was better in removing carious tooth structure owing to its EBE technology.
According to a study by Balachandran et al.,24 CMCR with BRIX3000 has emerged as a comfortable, less pain-inducing, effective, minimally invasive technique compared with traditional caries excavation. Although BRIX3000 takes more working time, it selectively eradicates only carious dentine while still conserving sound dentine, helping in remineralization. Moreover, it eliminates any need for local anesthesia, thus improving patient compliance.
Inamdar et al.25 performed an in vivo study where they compared BRIX3000, caries care, and smart burs in caries excavation and checked for bacterial count reduction. BRIX3000 had shown the highest reduction in bacterial count, followed by smart burs and carie care. Further studies are required on a larger sample to justify the implementation of newer CMCR agents as a part of minimally invasive procedures in pediatric dentistry. The limitations of the study included a lack of standardization of the number of times the chemomechanical agent was used for each tooth.
CONCLUSION
- Clinical efficacy was higher in the BRIX3000 agent group when compared to the conventional caries removal method.
- Wong–Baker Pain Rating Scale (WBPRS) scores were higher in the conventional method group as compared to the BRIX3000 agent. This shows that children experienced a higher amount of pain in the conventional method of caries removal.
- The CMCR method can be used as an efficient method in restorative procedures in pediatric dentistry.
Clinical Significance
The CMCR used as an alternative for caries removal in pediatric dentistry can prove to be very beneficial, especially in terms of anxiety and discomfort felt by the children.
ORCID
Seema Bargale https://orcid.org/0000-0003-4110-7990
Sejal Jain https://orcid.org/0000-0002-0859-9834
Anshula N Deshpande https://orcid.org/0000-0003-3467-2123
K S Poonacha https://orcid.org/0000-0002-5367-3685
Saylee Deshmukh https://orcid.org/0000-0002-6832-6942
Charmi Shah https://orcid.org/0000-0001-9623-5290
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