| Abstract|| |
Background: Chemomechanical removal of carious lesions consists of the dissolution of carious tissue by the application of a natural or synthetic agent, followed by atraumatic mechanical removal.
Aim: The aim of the present study was to assess the effectiveness of Papacarie Duo ® gel in the chemomechanical removal of carious lesions in primary teeth in comparison to the traditional method (low-speed bur).
Settings and Design: A randomized clinical trial was conducted with 20 children between 5 and 8 years of age.
Materials and Methods: Two teeth were treated in each child (split-mouth design), with the randomization of two methods: Group 1 - chemomechanical caries removal with Papacarie Duo™; and Group 2 - removal of carious dentin tissue using a low-speed bur. Both methods involved restoration with glass ionomer cement and follow up. The following aspects were evaluated: time required for the procedure; pain (face evaluation scale); rtention of the restorative material in the cavity; and the presence of secondary caries after 30 days.
Statistical Analysis Used: Chi-squared test, Student's t-test, and Wilcoxon test.
Results: No statistically significant differences between methods were found regarding time required for the procedure (P = 0.13), the occurrence of pain (P = 0.585), or restoration status at the 30-day clinical evaluation (P = 0.713).
Conclusion: The findings of the present study demonstrate that the two methods achieve similar results. The advantages of minimally invasive treatment, such as chemomechanical caries removal with Papacarie Duo™, are its ease of use, patient comfort, and the fact that it causes less damage to dental tissue.
Keywords: Dental atraumatic restorative treatment, dental caries, papain
|How to cite this article:|
Matsumoto SB, Motta LJ, Alfaya TA, Guedes CC, Fernandes KS, Bussadori SK. Assessment of chemomechanical removal of carious lesions using Papacarie Duo ™: Randomized longitudinal clinical trial. Indian J Dent Res 2013;24:488-92
Chemomechanical caries removal (CMCR) is an alternative to the treatment of active caries using re-mineralization techniques  or cavity preparation methods.  CMCR consists of the dissolution of carious tissue by the application of a natural or synthetic agent, followed by atraumatic mechanical removal.  This method is based on the norms of minimally invasive dentistry, allowing patient comfort and the preservation of healthy dental tissue.  CMCR was first described by Habib and co-workers in 1975, using 5% sodium hypochlorite.  Subsequent studies have introduced formulas with the same purpose, such as Caridex™, , Carisolv,™  and Papacarie™. 
|How to cite this URL:|
Matsumoto SB, Motta LJ, Alfaya TA, Guedes CC, Fernandes KS, Bussadori SK. Assessment of chemomechanical removal of carious lesions using Papacarie Duo ™: Randomized longitudinal clinical trial. Indian J Dent Res [serial online] 2013 [cited 2019 Jun 19];24:488-92. Available from: http://www.ijdr.in/text.asp?2013/24/4/488/118393
Papacarie™ was first marketed in Brazil in 2003. This product is a gel based on the combination of papain and chloramine for the removal of carious tissue, uniting the cleaning and healing properties of papain with the disinfecting characteristics of chloramine.  Papain interacts with the collagen exposed by the dissolution of minerals in the dentin due to the action of bacteria, softening the infected tissue and allowing its removal with blunt instruments; hence, there is no need for anesthesia or drills. , Clinical studies report satisfactory results with the use of this gel. ,,, The new version of the product is denominated Papacarie Duo™, which was released in 2011 and has the same efficacy plus a number of additional properties, such as a longer shelf life and no need for refrigerated storage. The gel has also greater viscosity, allowing more precise placement and less waste during the procedure.
The aim of the present study was to perform a longitudinal assessment of the effectiveness of Papacarie Duo™ for the chemomechanical removal of carious lesions in primary teeth in comparison to the traditional caries removal method using burs, analyzing the time required for the procedure and the need for anesthesia as well as retention of the restorative material in the cavity and presence of secondary caries after 30 days.
| Materials and Methods|| |
A randomized clinical trial was carried out to evaluate the efficacy of Papacarie Duo ® gel in comparison to a control group using the traditional caries removal method (burs) in a split-mouth design with a 30-day follow-up period. The study was carried out in compliance with regulating norms for research involving human subjects, having received approval from the City of Sao Paulo ethics committee and the Casa de Saúde Santa Marcelina under process number 170/11. The parents/guardians of the children signed a statement of informed consent authorizing the participation of their child.
Male and female children aged 5 to 8 years registered at the Basic Health Unit in the municipality of Rio Claro, state of Sγo Paulo, Brazil, were selected, with no restrictions regarding race. The following were the inclusion criteria: the absence of systemic health conditions; good behavior; and at least two deciduous molars with acute, active caries not surpassing 2/3 of the dentin and involving only the occlusal face (this condition was evaluated using bitewing radiographs), with a direct view and no clinical signs or symptoms of pulp involvement. The following were the exclusion criteria: Systemic health condition; lack of cooperation; Black class II, III or IV caries; carious lesion involving the enamel; deficient restorations; small carious lesions on the dentin (without access for manual scrapers); hidden carious lesions; clinical signs or symptoms of pulp involvement; and clinical impossibility of restoration.
The sample was made up of 20 children, among which 40 primary teeth were treated. For each child, one tooth was included in the study group and one was included in the control group. Randomization of the technique to be performed on each tooth was performed by lots. The teeth in Group 1 (G1) underwent CMCR using Papacarie Duo™ [Figure 1] and the teeth in Group 2 (G2) underwent conventional caries removal with a low-speed bur.
| Intervention|| |
G1 - Papacarie Duo ™
G1 underwent removal of carious dentin tissue with the use of Papacarie Duo™ and manual scrapers. The procedure consisted of prophylaxis with a Robinson brush and fluoridated dentifrice, followed by relative isolation (cotton roll and saliva suction device). This technique does not require the use of local anesthesia, thereby providing greater patient comfort, which is in compliance with the precepts of minimally invasive procedures. Relative isolation is required. The procedure can be performed in any setting, such as at schools or community centers, with no need for the infrastructure of a dental office. The Papacarie Duo™ was applied and allowed to act for 30 to 40 seconds. The carious dentin tissue softened by the gel was then removed using the back side of a curette. The procedure was repeated until there was no more carious dentin tissue to remove. The clinical evaluation was performed through an inspection of the texture of the remaining dentin using an exploratory probe. Time was recorded from the first application of the gel to the final inspection with the probe. The restoration was performed using glass ionomer cement (Ketac Molar Easy mix - 3 m ESPE™).
G2 - Traditional method
G2 underwent conventional removal of carious dentin tissue using a low-speed drill and bur. The procedure consisted of prophylaxis with a Robinson brush and fluoridated dentifrice, followed by the traditional removal of the carious tissue. The clinical evaluation was performed through an inspection of the texture of the remaining dentin using an exploratory probe. Time was recorded from the moment the low-speed bur was first applied to the final inspection with the probe. The restoration was performed using glass ionomer cement (Ketac Molar Easy mix - 3 m ESPE™).
The work team involved an operator who performed all the procedures and an assistant in the clinical phase. The assistant filled out the patient charts, recorded all important data, allocated the teeth to the different groups using a randomization chart, recorded the time requirement for each procedure using a chronometer, and recorded the score given by the child for pain using a face evaluation scale. All procedures were tested by a single, calibrated examiner during the initial phase of the study (pilot study), involving two teeth randomly allocated to two different groups.
Clinical criterion for terminating caries removal
Gel color and dentin hardness were taken into consideration for determining the termination of the caries removal process using Papacarie Duo™. The gel became limpid with the absence of further necrotized tissue (the gel does not undergo a change in color) and no further debris was found in the cavity. The remaining dentin tissue exhibited a surface hard enough to impede penetration with the exploratory probe. 
The time required for each procedure was recorded in minutes and seconds using a chronometer (Moure Jar™) beginning with the onset of the caries removal process until the complete removal of all carious tissue. The time was recorded on a specific chart. The need or non-need for anesthesia was also recorded.
An evaluation was performed 30 days after the procedures for the assessment of the retention of the restorative material in the cavity and the presence of secondary caries. For such, the following scores were attributed to the restoration: 0 = present, without defect; 1 = present, small defects on margin less than 0.5 mm in depth, with no need for repair; 2 = present, small defects on margin between 0.5 and 1.0 mm in depth, with need for repair; 3 = present, defects on margin 1.0 mm or more in depth, with need for repair; 4 = absent, restoration nearly completely lost, requiring retreatment; 5 = absent, other treatment performed for some reason; 6 = tooth absent for some reason; 7 = present, surface wear less than 0.5 mm, with no need for replacement; 8 = present, surface wear greater than 0.5 mm, with need for replacement; 9 = impossible to diagnose. 
The SPSS 17 program (IBM Corp., Chicago, IL, USA) was used for the data analysis, employing the chi-squared test. The Student's t-test was used for the analysis of mean values and the Wilcoxon test was used for comparisons between groups. The level of significance was set to 5% (P < 0.05).
| Results|| |
Twenty children between 5 and 8 years of age participated in the present study (10 females and 10 males). The teeth were randomly allocated to two groups based on the treatment method. [Table 1] displays the distribution of the teeth with regard to the type of treatment.
|Table 1: Distribution of primary teeth randomized for treatment with Papacarie Duo® (G1) or traditional caries removal (G2)|
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[Table 2] displays the time required to perform the two methods. The mean time required for the Papacarie Duo TM gel was higher. During conventional treatment (G2), one patient complained of pain and required anesthesia. The chronometer was not stopped during the application of the anesthesia, which led to the highest time value in [Table 2].
|Table 2: Time (in minutes) required for caries removal with Papacarie Duo<,sup>® (G1) and traditional method (G2)|
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No statistically significant differences between methods were found regarding the pain scale (P = 0.585) [Table 3] or restoration status at the 30-day clinical evaluation (P = 0.713) [Table 4].
|Table 3: Scores given by children regarding pain intensity using evaluation scale|
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| Discussion|| |
Based on the results of the present study, no statistically significant differences between methods were found regarding time required for the procedure, the occurrence of pain or restoration status at the 30-day clinical evaluation. It should be pointed out that the children experienced pain with both caries removal techniques. Regarding CMRC, the present results differ from findings described in previous studies, which report satisfactory findings regarding pain. , This discrepancy may be attributed to the interpretation of the drawings on the scale, as evidenced in investigations evaluating pain. , However, despite the reports of pain with both techniques in the present study, only one case required anesthesia.
The absence of the need for anesthesia during the application of CMCR (G1) is in agreement with findings reported in a study carried out by Bussadori et al. (2011), in which none of the 14 patients required anesthesia or reported discomfort during the procedure; this was attributed to the use of blunt curettes, the neutral pH of the product and the local action of papain, which favors the repair process.  According to the literature, CMCR, which is a minimally invasive method, allows eliminating the use of anesthesia and reducing pain symptoms. ,,
While the use of Papacarie Duo TM and the traditional caries removal method are equivalent with regard to time required to perform the procedure, the former only removes the infected dentin, leaving the healthy tissue for re-mineralization.  In contrast, the unnecessary removal of healthy tissue with the use of a low-speed bur can cause harm to the pulp.  These aspects underscore the importance of minimally invasive treatment. ,,
At the 30-day evaluation performed to analyze the retention of the restorative material in the cavity and determine the presence of secondary caries, the restoration was predominantly present and without defects following both procedures. Considering the properties of glass ionomer cement, such as the release of fluoride, chemical adherence to the tooth structure and availability for use in a variety of clinical scenarios,  this material can be widely employed and demonstrates strength when combined with other factors, such as proper oral hygiene. , The choice of this restorative material for the present study was due to the fact that it is widely used by dentists, including those acting in the public healthcare realm. 
Another point that merits attention with the use of Papacarie Duo™ is that there is no need to invest in dental equipment, as the method is simple and easy to apply. Like other atraumatic techniques, , CMCR can be implemented in communities with limited resources for dental care, thereby allowing the control of dental caries and the repercussions of this disease in the lives of pediatric patients.  Cost is another important factor. A comparative study carried out in South Africa on expenditures with atraumatic restorative treatment and conventional restoration with an amalgam and resin composite demonstrated that atraumatic restorative treatment is 50% less costly than conventional restorations placed in cavities prepared by burs. 27 In the comparison of the procedure using Papacarie™ and glass ionomer cement with the traditional method and an amalgam, a previous study reports respective expenditures of US$ 4.57 and US$ 8.76.  The lack of such a comparison constitutes a limitation of the present investigation. Thus, further studies are needed to examine the economic aspect of these procedures.
The findings of the present study demonstrate that both techniques achieve similar results. Papacarie Duo™ offers the advantages of being a minimally invasive method that is easy to apply and dispenses of dental equipment beyond the need for blunt scraping instruments, isolation of the operating field and water. Thus, this product can be used outside the dental office, such as at schools and other places in which dental equipment is not available.
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Thays Almeida Alfaya
Department of Rehabilitation Sciences Post Graduation Program, Nove de Julho University (UNINOVE), São Paulo
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2], [Table 3], [Table 4]