|
|
||||||||
|
J Am Dent Assoc, Vol 137, No 12, 1658-1666.
© 2006 American Dental Association | ![]() |
CLINICAL PRACTICE |
Efficacy and efficiency
| ABSTRACT |
|---|
|
|
|---|
Methods. The authors collected data from 50 children during operative appointments at which caries was removed using one of the two methods.
Results. Complete caries removal within 15 minutes was achieved in only 57.7 percent of the CMCR-treated teeth. In 42.3 percent of these teeth, residual caries was removed using TM. CMCR was almost eight times more time-consuming than was TM when used to excavate dentinal-depth occlusal lesions with minimal cavitation. There was no significant difference between CMCR and TM in the number of subjects who needed to undergo local anesthesia.
Conclusions. The authors found no direct clinical advantage in using CMCR over using TM for treating occlusal dentinal lesions with minimal cavitation in pediatric patients.
Key Words: Dental restoration; pediatric dentistry; carious lesions; caries; dental cavity preparation
The development of alternative and more preservative, selective methods for caries removal could revolutionize operative dentistry in the age of searching for minimally invasive procedures. Chemomechanical caries removal (CMCR) has been introduced as an alternative method of caries removal. CMCR is a method of caries removal based on dissolution. Instead of drilling and using sharp excavators, this method uses a chemical agent assisted by an atraumatic mechanical force to remove soft carious tooth structure. The available CMCR system uses a gel, containing sodium hypochlorite and three amino acids (glutamic acid, leucine and lysine) as active ingredients and blunt instruments to selectively remove the denatured dentin, leaving the affected dentin intact.1,2 A comprehensive overview of various methods of caries removal has been published by Banerjee and colleagues.3
In vitro evaluations of the clinical effectiveness of CMCR showed that caries removal could be achieved.1,4 In addition, the effect of CMCR on sound dentin5,6 and carious dentin7,8 has been explored. Most findings supported the claim that CMCR is clinically efficacious and similar to the traditional method (TM) of caries removal using a bur. Some studies, however, have found up to 70 percent residual caries after CMCR has been used for up to 15 minutes.811 While complete caries removal was achieved in most cases,1215 the time required time for CMCR was significantly longer than the time for TM. Only Nadanovsky and colleagues15 reported similar average treatment times when they compared CMCR with excavation with hand instruments only. Overall, a majority of the studies concluded that the clinical use of CMCR was efficacious and more comfortable for the patient.
![]()
Pediatric patients and CMCR.
TOP
ABSTRACT
Pediatric patients and CMCR.
METHODS
RESULTS
DISCUSSION
CONCLUSIONS
REFERENCES
Seven studies investigated the use of CMCR in pediatric treatments compared with the use of TM (Table 1
).1622 Studies investigating efficacy concluded that complete caries removal was not achieved in 16.7 to 90.0 percent of the cases. All of the studies reported longer to considerably longer time (> three times) was needed for CMCR compared with TM.
|
The purpose of our prospective, randomized controlled clinical trial was to compare CMCR and TM concerning efficacy (in achieving complete caries removal in well-described occlusal lesions into dentin with limited enamel involvement in primary molars), efficiency and the need for local anesthesia when treating patients. Results concerning operators and pediatric patients responses to both methods will be reported in an article about the psychosocial and behavioral outcomes of this study.24
| METHODS |
|---|
|
|
|---|
Cavity preparation. Before the treatment appointment, the operator randomly assigned each tooth to either the CMCR or the TM (control) group using the flip of a coin. He randomized 26 subjects to the CMCR group and 24 subjects to the TM group. He then isolated the study tooth with cotton rolls or dry angles and instructed the subjects to raise their left hands if they felt any discomfort ("a hurt on your tooth"). He started a timer and made an "enamel-only" minimal access opening of 2 to 3 millimeters with a no. 330 carbide bur in high speed under water coolant to facilitate proper access of the lesion.
Evaluation criteria. The operator assessed complete caries removal using visual clinical criteria accommodating for CMCR25 and by relying on tactile sensations. In case of complete caries removal, he judged the explorer to have passed easily over hard sound tooth tissue and did not "catch" or give a "tug-back" sensation, which would indicate carious dentin. An independent evaluator confirmed complete caries removal. If they still noted active caries, both dentists (the operator and the evaluator) examined the area in question and reached consensus. The operator removed residual active caries using the assigned method or completed caries removal with a slow-speed handpiece and round bur if caries still was present after three CMCR cycles or 15 minutes of CMCR-treatment.
CMCR steps. The operator applied freshly prepared gel (Carisolv multimix gel, lot no. 1124576, MediTeam, Göteborg, Sweden) to carious dentin for a minimum of 30 seconds. When applying the gel, the operator started a second timer to record the time needed for caries to be removed completely. He used custom CMCR hand instruments with blunt tips to remove superficial, softened dentin. He then reapplied the gel to the cavity, while scraping until the gel was no longer cloudy and the remaining surfaces felt hard. When the operator assessed that complete caries removal had been attained, he rinsed and dried the cavity preparation. This series of steps was considered a single CMCR cycle. If caries was detected after the first cycle, the operator reapplied the gel and repeated the entire process. We allowed for a maximum of three CMCR cycles over 15 minutes to achieve complete caries removal. In the event that caries removal was not achieved after three cycles, we completed additional caries removal using a slow-speed hand-piece and round bur.
TM steps. After completion of the outline of the preparation, operator started a second timer and used a regular slow-speed handpiece and round bur for caries removal. At variable speed (below 12,000 revolutions per minute for enhanced tactile sensation) he used bur sizes 2, 4, 6 and 8, aiming for complete caries removal. If needed, additional hand instruments such as small, medium and large spoon excavators were used.
Local anesthesia. Although we initiated all treatment without the subjects being under local anesthesia, we administered local anesthetic if requested by the subject (for discomfort) or the operator (for the perceived benefit of the subjects safety and comfort or to avoid negative behavior). We recorded the time needed to achieve effective anesthesia of the tooth, though we did not include this time in the reported treatment times.
Tooth restoration. All of the teeth in this study were clinically and radiographically asymptomatic. We applied indirect pulp protection (Vitrebond Light Cure Glass Ionomer Liner/Base, 3M ESPE, St. Paul, Minn.) on 11 teeth when indicated and restored the teeth using a standard adhesive composite system (Adper Single Bond Adhesive, 3M ESPE, and Filtek Z250, 3M ESPE) according to the manufacturers instructions.
| RESULTS |
|---|
|
|
|---|
|
The treatment characteristics in both groups showed no significant differences concerning the largest bur size used for caries removal. However, it was more likely that medium and large hand instruments were used for caries removal in the CMCR group than in the TM group. The actual cavity depth, which we assessed before restoring the teeth, was significantly different between the two groups; the CMCR group had 26.9 percent superficial lesions and 73.1 percent deep lesions, and the TM group had 62.5 percent superficial lesions and 37.5 percent deep lesions. Maintaining a dry field was problematic in 42.3 percent of subjects in the CMCR group compared with only 8.3 percent in the TM group (P = .007).
Table 3
(page 1661) shows an overview of the efficacy and efficiency of the two treatment methods. Concerning the efficacy of CMCR compared with TM, we found that complete caries removal was achieved in 19.2 percent of the subjects after one CMCR treatment, in 30.8 percent of subjects after two cycles, and 7.7 percent of subjects after three cycles. In 42.3 percent of the subjects in the CMCR group, we used a slow-speed handpiece and bur after 15 minutes of CMCR (three cycles) to complete caries removal. We found no differences between the two treatment groups in the percentage of subjects with a clean dentinoenamel junction (DEJ), the color of the cavity floor and whether indirect pulp treatment was needed.
|
Using chemomechanical caries removal in occlusal lesions with minimal access in pediatric patients is less efficacious, requires substantially more time for caries removal and does not lower the demand for treatment under local anesthesia.
While we expected that fewer subjects in the CMCR group would need to be treated while under anesthesia compared with subjects in the TM group, we found no significant difference between the groups in the percentages of subjects who needed to be treated under local anesthesia or in the phase of treatment in which local anesthetic was administered (Table 2
).
| DISCUSSION |
|---|
|
|
|---|
Overall, the results were less favorable for the CMCR method. CMCR was less able to achieve complete caries removal for pediatric subjects with dentinal-depth occlusal lesions with limited enamel access in primary molars and was more time intensive (604.19 ± 227.54 SD seconds) than was TM (80.71 ± 83.00 SD seconds). In addition, we found no significant differences concerning the need for subjects to be treated under local anesthesia in the CMCR group compared with the TM group.
These results, however, should be reviewed with three issues in mind. First, while the caries removal criteria (clinical visual and tactile criteria) we used in our study accommodated the CMCR method, they still followed the principle that complete caries removal was the desired outcome. All results in our study addressing the clinical efficacy of CMCR need to be interpreted with respect to the objective of ensuring complete caries removal. Most likely, the results would have been more favorable for CMCR if we had applied less stringent caries removal criteria (as advocated by minimally invasive strategies2629). Second, many of the previous clinical studies investigating the clinical efficacy of CMCR treated primarily open and easily accessible lesions. Our study focused on dentinal-depth occlusal lesions in primary teeth, often with minimal cavitation. Third, while the subjects were assigned randomly to the two treatment groups, we found a significant discrepancy in lesional depth between the two groups; there was a larger number of deep lesions in the CMCR group than in the TM group. However, even when we considered these three potentially moderating factors, the size of the effect was so powerful that we could draw the conclusion that using CMCR to treat occlusal lesions with minimal access in pediatric patients is less efficacious, requires substantially more time for caries removal and does not lower the demand for treatment under local anesthesia compared with TM.
Efficacy. In our study, 42.3 percent of all CMCR-treated teeth required further caries removal with a slow-speed handpiece and bur despite 15 minutes of repeated CMCR applications with proper instrumentation. We found residual active caries mostly on the walls of the preparation. If indirect pulp treatment was required, we did not assess it as "ineffective" caries removal unless the treatment method was unable to remove caries from the circumferential walls. In general, the operator found pulpal caries on the floor easier to instrument in CMCR than the caries on the walls of the preparation. Specially designed Carisolv instruments are equipped with "noncutting" surfaces so as to not traumatize or remove reversibly affected dentin. Ideally, these instruments are supposed to be capable of removing CMCR-softened infected dentin with a more whisking type force.30 In our study, the operator noticed that on several occasions carious dentin (dental explorer tug-back present) could not be removed after CMCR treatment unless he applied significant force. However, the amount of caries removed after CMCR may have been ample and sufficient for minimally invasive occlusal dental restorations.28,3133
In adult patients, complete caries removal was achieved in most studies (
90 percent).12,13,15 In a study by Ericson and colleagues,12 the efficacy of CMCR was superior, with 106 of 107 CMCR-treated lesions achieving complete caries removal. Although different types of lesions were treated (only 14 occlusal lesions), the discrepancy between this study and ours with respect to caries removal efficacy is perplexing. However, 42 of the 106 (39.6 percent) CMCR-treated teeth in their study required 11 minutes or more of treatment time to achieve complete caries removal. Therefore, it is possible that if CMCR treatment had been continued in our study beyond the 15-minute limitation, complete caries removal could have been achieved. Only one study with adult patients reported completion of caries removal by drilling (21.7 percent),14 and only one study of the primary dentition reported that all teeth were caries-free.21 Two additional studies did not mention whether caries was completely removed.19,20 In these reports, readers may assume that the caries was removed completely before restoration. In contrast with the studies of adult patients, however, three studies that included children between 3 and 13 years of age reported high percentages of caries remaining in the cavity after CMCR. Maragakis and colleagues17 reported remaining caries in 37.5 percent of the cases, while Balciuniene and colleagues16 stated that in 60 percent of cases bur instrumentation was needed to complete the removal after CMCR. Munshi and colleagues18 described CMCRs performance as "very efficient" in soft carious lesions (though 17 percent had to be completed by bur) but in 90 percent of hard, arrested dentinal lesions, CMCR was not able to result in clean cavity walls. As the two groups in our study did not differ statistically in distribution of hard and soft carious tissue, this was not an issue in our comparison of the two methods. The outcome of our study corroborated the results of these pediatric studies.
Efficiency. The CMCR and TM groups differed significantly in the average time used to complete the outline of the preparation with high speed before caries removal (89.73 ± 33.41 SD seconds versus 52.89 ± 39.41 SD seconds, respectively; P = .003). During the outline of the cavity preparation in CMCR teeth, one of our objectives was to ensure that the DEJ was free from caries. Given the finding of Cederlund and colleagues,34 who showed that six of the 10 teeth in their study treated with CMCR had residual caries at the DEJ, it seemed important to avoid this problem. Two other studies drew attention to access opening, stressing the need to remove the enamel carefully to maximize the efficiency of CMCR15 and reporting an extended access time in 70 percent of CMCR cases.19 Another one of our objectives was to provide adequate access for effective hand instrumentation. Because many of the lesions in our study were less than 2 mm in diameter (as visualized from the enamel), simply removing the infected enamel and DEJ caries would not have provided sufficient access for the CMCR instruments to reach the dentinal caries. While the operator also took these precautions with TM teeth, he may have paid more attention with the CMCR group to ensure that there were a healthy enamel cavosurface margin and a caries-free DEJ.
In our study, there were significantly more deep lesions in the CMCR group than in the TM group, which may have contributed to longer time needed to complete the outline of the preparation. While the deeper carious lesions may have had more enamel access to begin with, these lesions still required meticulous preparation with the high-speed handpiece to ensure healthy enamel cavosurface margins and a caries-free DEJ. Overall, the treatment time was more than doubled in the CMCR group than in the TM group (934.96 ± 279.25 SD seconds versus 409.58 ± 169.61 SD seconds, respectively). Since the difference in high-speed access time was approximately 37 seconds and the average restoration time was similar in both groups, this great difference in total treatment time predominantly results from the method of caries removal.
Our study confirmed that extra time was needed for CMCR; this result also was reported in similar studies.1214,16,17,1922,35 Overall, the total treatment time was significantly higher in the CMCR group compared with the TM group (934.96 ± 279.25 SD seconds versus 409.58 ± 169.61 SD seconds, respectively; P = .000). The profound difference in the caries removal time for all lesions was attributed primarily to the longer total treatment time for CMCR.
The average CMCR time for complete caries removal in this study decreased to 484 ± 187.96 SD seconds when we considered only those lesions that had been treated successfully within the 15-minute time limitation. This time was about 18 percent longer than that reported by Maragakis and colleagues.17 In their study, the time for successful CMCR caries removal within a 15-minute period was reported to range between 406 seconds and 837 seconds; the average time was 411 seconds. In a study without a control group, Munshi and colleagues18 reported mixed results; the average CMCR time differences for soft and hard carious lesions were 296 ± 0.58 SD seconds and 370 ± 64 SD seconds, respectively. However, as the two groups in our study did not differ statistically in the distribution of hard and soft carious tissue, this was not an issue when we compared the two methods.
In another study, a new modified Carisolv gel showed promise for 12 to 22 percent shorter CMCR time.35 In addition, different approaches using proteolitic enzymes36 with a faster effect37 are being investigated.
Local anesthesia. At least one study has credited CMCR with being as efficient as TM when the time needed for local anesthetic administration is taken into consideration.12 Since two studies12,17 and our investigation demonstrated that complete caries removal time for CMCR often takes longer than 10 minutes and that caries removal time with comparative lesions for TM takes a maximum of a few minutes, this statement has limited validity even when taking anesthesia in the mandible into consideration. In our investigation, six of the 26 teeth treated with CMCR required treatment under local anesthetic, which took additional time and increased the total chair time needed for the CMCR method.
Clinical relevance. From a clinical standpoint, clinicians should not expect CMCR to achieve complete caries removal in all cases. However, increased patient comfort may make CMCR useful in minimally invasive strategies using incomplete caries removal, especially when extra appointment time can be scheduled. In addition, extra time might be needed when using CMCR in children, as administering local anesthetic should be considered when patients report pain; 28 percent of the subjects in our study reported pain.
| CONCLUSIONS |
|---|
|
|
|---|
| FOOTNOTES |
|---|
| REFERENCES |
|---|
|
|
|---|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |