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Randomized Trial of Partial vs. Stepwise Caries Removal : 3-year Follow-up

M. Maltz, R. Garcia, J.J. Jardim, L.M. de Paula, P.M. Yamaguti, M.S. Moura, F. Garcia, C. Nascimento, A. Oliveira and H.D. Mestrinho J DENT RES published online 14 September 2012 DOI: 10.1177/0022034512460403 The online version of this article can be found at: http://jdr.sagepub.com/content/early/2012/09/14/0022034512460403

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RESEARCH REPORTS
Clinical

M. Maltz1*, R. Garcia1, J.J. Jardim1, L.M. de Paula2, P.M. Yamaguti2, M.S. Moura1, F. Garcia2, C. Nascimento1, A. Oliveira2, and H.D. Mestrinho2
Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil; and 2Brasilia University, Brasilia, DF, Brazil; *corresponding author, marisa.maltz@gmail.com J Dent Res X(X):xx-xx, XXXX
1

randomized trial of Partial vs. stepwise caries removal: 3-year Follow-up

AbstrAct
This randomized, multicenter clinical trial evaluated the effectiveness of 2 treatments for deep caries lesions partial caries removal (PCR) and stepwise excavation (SW) with respect to the primary outcome of pulp vitality for a 3-year followup period. Inclusion criteria were as follows: patients with permanent molars presenting deep caries lesions (lesion affecting 1/2 of the dentin on radiographic examination), positive response to a cold test, absence of spontaneous pain, negative sensitivity to percussion, and absence of periapical lesions (radiographic examination). Teeth randomly assigned to PCR (test) received incomplete caries removal and filling in a single session. Outcome success was evaluated by assessment of pulp vitality, determined by pulp sensitivity to a cold test and the absence of periapical lesions. Data were analyzed by a Weibull regression model with shared frailty term (survival analysis). At baseline, 299 treatments were executed: PCR, 152 and SW, 147. By the end of the 3-year follow-up period, 213 teeth had been evaluated. Adjusted survival rates were 91% for PCR and 69% for SW (p = 0.004). These results suggest that there is no need to re-open a cavity and perform a second excavation for pulp vitality to be preserved (Clinical trials registration NCT00887952).

IntrODuctIOn

KEY WOrDs: dental caries, clinical trial, permanent dentition, survival analysis, permanent dental restoration, dental pulp.

DOI: 10.1177/0022034512460403 Received April 5, 2012; Last revision August 8, 2012; Accepted August 8, 2012 International & American Associations for Dental Research

he treatment of asymptomatic teeth presenting deep caries lesions is usually based on traditional techniques that involve the complete removal of the soft, demineralized dentin. In these cases, it is common to have the pulp exposed during the operative procedure (Magnusson and Sundell, 1977; Leksell et al., 1996; Ricketts et al., 2006). Previous investigations have shown that conservative treatments of the exposed pulp resulted in a poor prognosis in follow-up trials (Barthel et al., 2000; Bjrndal et al., 2010). Stepwise excavation (SW) is an option for the treatment of deep lesions. It involves initial excavation, in which the necrotic and disorganized tissue is removed, leaving soft tissue over the pulp wall. The cavity is then temporarily sealed, allowing the pulp to react and produce tertiary dentin (Bjrndal, 2008). The cavity is subsequently re-opened, and the remaining demineralized dentin is removed. This technique involves less pulp exposure compared with complete caries removal during a single session (Magnusson and Sundell, 1977; Leksell et al., 1996). One-year evaluation of SW revealed a survival rate of 74 to 91% (Bjrndal and Thylstrup, 1998; Bjrndal et al., 2010). However, SW requires 2 sessions for treatment completion, resulting in additional costs and discomfort to the patient; further, there is a probability of pulp exposure during the second procedure (Bjrndal and Thylstrup, 1998; Bjrndal et al., 2010). Because of these problems and the evidence pertaining to lesion arrest after sealing of the cavity (Bjrndal and Larsen, 2000; Maltz et al., 2002; Alves et al., 2010), there is discussion in the literature concerning the necessity for cavity re-opening (Ricketts et al., 2006). Three clinical trials have studied partial caries removal (PCR) on permanent teeth: Two of these trials included lesions reaching the outer half of dentin (Mertz-Fairhurst et al., 1998; Bakhshandeh et al., 2011), and the third involved lesions reaching the inner half of dentin (Maltz et al., 2011). All of these studies reported no detrimental effects when demineralized tissue was left in the cavity. Despite these, there are no long-term randomized, controlled trials that support a 1-step partial excavation followed by the immediate placement of a filling on permanent teeth. The aim of this randomized, multicenter trial was to compare PCR and SW with respect to the primary outcome of pulp vitality for a 3-year follow-up period.

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Maltz et al. Objectives and Outcome

J Dent Res X(X) XXXX

stuDY POPulAtIOn & MEthODs

Participants
This multicenter, randomized clinical trial included 299 treatments performed between 2005 and 2007. Treatments were evaluated up to year 3 and were executed at 2 centers (Porto Alegre and Braslia) by 22 dentists (19 generalists and 3 specialists) working either at Public Health Services or Brazilian Federal Universities. Participants were selected from among the regular attenders at Public Health Services and local schools. The inclusion criteria were: permanent molars presenting deep caries lesions (reaching 1/2 of the dentin on radiographic examination); positive response to a cold test (refrigerated gas at -20C; Aerojet, Rio de Janeiro, RJ, Brazil); absence of spontaneous pain; negative sensitivity to percussion; and absence of periapical lesions (radiographic examination). Patients were excluded if they presented cuspal loss or caries beneath the gingival margin. Dental public health services are free for the entire population in Brazil, so the participants did not receive incentives to join the study. All individuals were informed of the research purpose and signed an informed consent; their dental needs were addressed by the researchers throughout the study. The study was approved by the Ethics Committees from the Federal University of Rio Grande do Sul (protocol 18/05), the Porto Alegre Municipal (protocol 27/06), and the Brasilia University Hospital (protocol 045/2005).

The primary success outcome was pulp vitality, evaluated by: a positive response to cold test, absence of spontaneous pain, negative sensitivity to percussion, and absence of periapical lesion (radiographic examination). The null hypothesis was that there is no difference among treatments with regard to pulp status after 3 yrs of their completion. Data such as age, gender, filling material, and the number of surfaces restored were collected and analyzed for evaluation of their correlation with the outcome.

sample size
Samples were estimated based on the difference in success rates between treatments [60.9% (SW) and 82% (PCR) at 5-year follow-up] at = 5%, with a power of 90%; this resulted in 76 treatments per group (Maltz et al., 2007; Parolo et al., 2007). A drop-out rate of 56% was estimated based on a study carried out with a similar population, thus increasing the number of restorations to 119 per group (Busnello et al., 2001). The sample size calculation was performed with the tool available at http://www. lee.dante.br/pesquisa/amostragem/calculo_amostra.html.

randomization/Allocation concealment and blinding

The randomization unit was the tooth, and the randomization procedure was performed as follows. A number corresponding to each treatment group was printed on pieces of paper and kept in dark flasks. A paper was selected from the flask by a person other than the operator, and the treatment indicated was executed (test/control). The filling material was determined on a weekly basis, alternating between amalgam and resin in each treatment center. Blinding of the patients was not possible, because a range of appointments was required for each treatment. The operator was blinded until randomization into groups, to avoid biases with regard to the removal of decayed dentin. The treatment results were assessed blindly by the statistician. Data were recorded in the clinical files and then transferred to a digital system (http://odonto.cityzoom.net).

Interventions
All dentists were updated and trained by two researchers before the study began. The materials used to perform the treatments were supplied by the researchers to all treatment units. The selected participants underwent the following treatment: After local anesthesia and rubber dam isolation, the lesion was accessed with a diamond bur. Then, complete excavation from cavity walls was performed with dentin excavators or low-speed burs, according to the hardness-tactile criteria (hardness to probe). Partial removal of carious dentin (only disorganized dentin was removed) on the pulp wall was performed by manual instruments (Bjrndal and Thylstrup, 1998). The cavity was washed with distilled water and dried with sterile filter paper. The teeth were randomized, and those allocated to the test group (PCR) received reconstruction of the surrounding walls and pulp lining with glass-ionomer cement (Vitro Fil, DFL, Rio de Janeiro, RJ, Brazil). Teeth were then filled with composite resin (Tetric EvoCeram, Ivoclar/Vivadent, Liechtenstein) or amalgam (GS-80, SDI, Bayswater WA, Australia). Teeth allocated to the control group (SW) received indirect pulp capping with calcium hydroxide cement (Dycal, Caulk/Dentsply, Rio de Janeiro, RJ, Brazil) and temporary filling with a modified zinc oxideeugenol cement (IRM, Caulc/Dentsply, Rio de Janeiro, RJ, Brazil). The cavity was re-opened after a median time of 90 days (25th percentile = 60 days; 75th percentile = 150 days; mean, 120 120 days), the remaining decayed dentin was removed, and the teeth were restored.

statistical Methods
Parametric survival models (Exponential, Weibull, Lognormal, and Generalized gamma) with individual level frailty were developed for outcome with treatment (SW, PCR) as the exploratory factor, after adjustment for other potential predictors: region, gender, age ( 17 yrs, > 17 yrs), filling material, and number of restored surfaces. Because the carious responses are clustered within an individual, statistical methods must account for the correlation between teeth within an individual. We used the goodness-of-fit test with the likelihood statistic to compare nested models and the Weibull regression model for adjusting the data. We performed survival analyses to estimate therapy success rates and to compare completed and uncompleted SW, and survival curves were compared with a Weibull regression model. The censored observation (missing data) was set for all

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J Dent Res X(X) XXXX

Randomized Trial of Partial vs. Stepwise Caries Removal

patients lost to follow-up. The time to event was recorded and analyzed in days. Bivariate analyses at the teeth level were conducted with generalized loglinear models (to compensate for intraparticipant correlations) to compare teeth evaluated at the follow-up examination and for those who had not returned for examination. The significance level was set at 5%, and the tooth was the unit of analysis. All analyses were performed with STATA software, version 10, and SAS software, version 9.2.

rEsults
Participant Flow and recruitment

PCR

This study was evaluated as an intentionto-treat analysis. Consequently, protocol deviations were included in the study sample. Cases of restoration failure, secondary caries, or absenteeism during the second SW appointment were treated and followed in the survival analysis without changing trial arms. Patients presenting with filling failure or secondary caries received restoration repair. When the filling failure involved the PCR pulp wall, patients received the same treatment for which they had been enrolled at the beginning of the study. In Figure 1. Participant flow and follow-up. the SW group, 46 treatments were not performed as planned, since the patients year 3, after adjustment for the other potential predictors, the did not return for the second appointment 90 days after the first success rates for each group were 91% and 69% for PCR and one. When contacted, they received treatment as indicated in the SW, respectively (p = 0.004). The causes of failure in the PCR SW protocol. All patients were contacted once a year for followgroup were pulpitis (4) and pulp necrosis (1). In the SW group, up examinations. the causes of failure included pulpitis (11), necrosis (5), pulp exposure followed by endodontic treatment (2), osteitis (1), baseline Data tooth extraction (1), and tooth fracture (1). The comparison of In total, 299 treatments [SW, 147; PCR, 152 (Fig. 1)] were persurvival rates between teeth that had completed (84) and uncomformed in 233 patients. The study sample was composed mainly pleted SW (17) indicated 88% and 13% success rates, respecof low-income individuals (Instituto Brasileiro de Geografia e tively (p < 0.001) (Fig. 2B). Estatstica, 2012). The mean age was 17.17 yrs (median, 14 yrs; minimum, 6 yrs; maximum, 53 yrs), with a standard deviation of Ancillary Analyses 10.91 yrs. The mean DMFT was 7.9 5.7. From all teeth included The Weibull regression model with individual level frailty was in the study, 62% were first molars, 33% were second molars, and developed for outcome with treatment (SW, PCR) as the explor5% were third molars. There were no differences between treatatory factor, after adjustment for region, gender, age, number of ment groups regarding age, monthly family income, filling materestored surfaces, and filling material. Significant associations rial, the number of restored surfaces, and gender. were found for treatment, the number of restored surfaces, and age. The outcome was more favorable when 1 surface was numbers Analyzed and Outcomes restored compared with 2 or more surfaces, and when the treatIn total, 213 teeth (112 that underwent PCR and 101 that underment was PCR compared with SW (Table 1). Teeth evaluated at went SW) were followed up at year 3. Results from the survival the follow-up examination were compared with those of particianalysis for the Weibull regression are presented in Fig. 2A. At pants who had not returned for examination (Table 2).

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Maltz et al.

J Dent Res X(X) XXXX

Figure 2. Survival rates of (A) the test (partial caries removal PCR) and control (stepwise excavation SW) and (b) the completed and uncompleted SW at 3-year follow-up (Weibull regression model).

table 1. Association between Pulp Necrosis and Explanatory Variables (Weibull regression) Multivariable Weibull Regression Variables Gender Male Female Region Midwest South Age 17 yrs > 17 yrs Treatment Stepwise excavation Partial caries removal Filling material Amalgam Composite resin Number of restored surfaces One Two or more N (%) 83 (39) 130 (61) 106 (50) 107 (50) 140 (66) 73 (34) 101 (47) 112 (53) 77 (36) 136 (64) 184 (86) 29 (14) HR 1.00 1.35 1.00 1.69 1.00 0.35 1.00 0.21 1.00 1.62 1.00 5.24 95 % CI p 0.531 0.52 3.49 0.319 0.60 4.75 0.095 0.10 1.20 0.005 0.07 0.63 0.353 0.58 4.48 0.026 1.21 22.59

HR = Hazard ratio; CI = confidence interval.

DIscussIOn
A comparison was made between variables associated with teeth that were included in the survival analysis (213) and those that were lost to follow-up (86). This comparison showed statistically significant differences in gender and number of surfaces restored. The number of surfaces restored was highlighted as being the strongest indicator of filling failure that could potentially lead to pulpal necrosis. Since most restorations of 2 surfaces were included in the survival analysis, the difference found between

the groups evaluated and not evaluated with respect to the number of surfaces involved in the restoration does not seem to compromise the results of the study. If the treatments not evaluated were mostly restorations with 2 or more surfaces, the results of survival analysis could be biased, showing treatment results more favorable than they actually were. SW has been considered the most conservative treatment for asymptomatic teeth presenting deep caries lesions. In comparison with complete caries removal, SW leads to less pulp exposure and provides better outcomes with regard to preserving

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J Dent Res X(X) XXXX

Randomized Trial of Partial vs. Stepwise Caries Removal

table 2. Comparison between Evaluated and Non-evaluated Treatments Variable Gender Male Female Region Midwest South Age 14 yrs > 14 yrs Treatment Stepwise excavation Partial caries removal Filling material Amalgam Composite resin Number of restored surfaces One Two or more * p value from generalized log-linear models. Evaluated 83 (39.0) 130 (61.0) 106 (49.8) 107 (50.2) 108 (50.7) 105 (49.3) 101 (47.4) 112 (52.6) 77 (36.2) 136 (63.8) 184 (86.4) 29 (13.6) Non-evaluated 19 (22.1) 67 (77.9) 0.543 39 (45.3) 47 (54.7) 0.381 49 (57.0) 37 (43.0) 0.360 46 (53.5) 40 (46.5) 0.062 42 (48.8) 44 (51.2) 0.031 83 (96.5) 3 (3.5) p* 0.017

pulp sensitivity (Bjrndal et al., 2010). Clinical trials have demonstrated that conservative treatments performed after pulp exposure lead to a poor prognosis. Barthel and collaborators (2000) investigated 123 teeth treated with direct pulp-capping. The success rates after 5 and 10 yrs were 44.5% and 13%, respectively. Bjrndal et al. (2010) carried out a clinical trial comparing direct pulp-capping with partial pulpotomy, showing no difference between these treatments. There is little evidence from clinical trials concerning conservative treatments of the exposed pulp, and little information can be gathered in systematic reviews (Miyashita et al., 2007). In our study, the success rates for SW were 93% and 69% after 1- and 3-year follow-up, respectively. The completion of SW necessitates 2 sessions, adding costs and patient discomfort. Furthermore, patients may not return to complete the treatment, as observed in our study. Restorations in patients with uncompleted SW showed a very low survival rate. Zanata and collaborators (2003) evaluated the survival of glass-ionomer cement and zinc oxide-eugenol restorations in 81 caries-active women. The results indicated that zinc oxide-eugenol does not provide good cavity sealing at 2-year follow-up. The survival rates of PCR in this study after 1 and 3 yrs were 98% and 91%, respectively. In permanent teeth, uncompleted caries removal of deep lesions has previously been studied in only 1 single-arm clinical trial. In this study, success rates for PCR were 97% and 90% after 1 and 3 yrs, respectively (Alves et al., 2010; Maltz et al., 2011). In our study, a comparison between SW and PCR treatments showed statistically significant differences after 3 yrs. This difference could be explained by the high number of uncompleted SW treatments and by the type of analysis performed in the study (intention-to-treat). Completed SW presented survival rates similar to those of PCR. Weibull regression showed that PCR was associated with a 79% lower risk of failure as compared with SW. This must be

considered in the making of treatment decisions, because researchers and clinicians are still reluctant to indicate incomplete caries removal in daily practice. In a study conducted in Public Health Services in Porto Alegre (Brazil), treatment decisions for deep lesions were assessed. Across a total of 155 observations, the most common was complete caries removal in a single session (61.30%) (Weber et al., 2011). Similar results were observed in a study evaluating the North American dentist population:The majority of respondents (62%) removed carious dentin completely, even if the procedure was associated with the risk of pulp exposure, while 18% performed partial caries removal (Oen et al., 2007). Partial dentin removal showed a statistically significant improvement with regard to the maintenance of pulp vitality as compared with SW after a 3-year follow-up period. This difference might be attributed to the low success rate of incomplete SW treatments. No adverse events relating to soft demineralized dentin left on the pulpal wall of the cavity were observed.

AcKnOWlEDgMEnts
We acknowledge the support of CAPES, CNPq (40.3420/04-0), FAPERGS (04/1531-8), and the industries Ivoclar/Vivadent (Schaan, Liechtenstein), DFL (Rio de Janeiro, Brazil), SDI (Bayswater WA, Australia), and Hu-Friedy (Chicago, IL, USA). The authors declare no potential conflicts of interest with respect to the authorship and/or publication of this article.

rEFErEncEs
Alves LS, Fontanella V, Damo AC, Oliveira EF, Maltz M (2010). Qualitative and quantitative radiographic assessment of sealed carious dentin: a 10-year prospective study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 109:135-141.

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Maltz et al.

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