1

Introduction

Traditional caries management involves removal of all softened dentine to a level of well-mineralized structure . If caries is deep into dentine and a tooth has clinical and radiographic signs of vitality and health, caries removal should be focused and deliberate to avoid pulp exposure . Exposing the pulp while removing caries introduces bacteria, reducing the likelihood that it will maintain health and vitality over time .

If a tooth has deep dentine caries and a healthy pulp diagnosis, caries can be removed using a total or partial caries removal technique. Total caries removal is any method that completely removes the central as well as the peripheral caries biomass before definitive restoration. One-step total caries excavation removes all caries in one visit. However, this reportedly results in a higher incidence of pulp exposures than alternatives . Stepwise excavation (SWT) removes all caries in two appointments while reducing the risk for pulp exposure compared to single-visit procedures . Stepwise excavation removes all superficial and most of the central caries biomass at the first visit . At the conclusion of the first visit, a thin layer of infected dentine is deliberately left to cover the pulp and protect it from mechanical exposure, and the carious defect is provisionally restored. After a pre-specified time interval the tooth is re-entered, residual caries removed, and the tooth definitively restored . At SWT completion, only greyish, hard dentine covers the pulp that is equal in hardness to sound dentine as judged by gentle probing with a sharp explorer . The purpose of the first excavation and restoration is to arrest caries progression and allow tertiary dentine formation, permitting residual caries removal at the second visit to proceed with less risk for pulp exposure .

An alternative to SWT is partial caries removal (PCR), also known as incomplete caries removal , or indirect pulp capping . Like the SWT, PCR removes only peripheral caries, leaving a thin layer of carious dentine immediately covering the pulp. However, at PCR completion this thin layer of infected carious dentine is deliberately retained, covered with a liner, and the tooth definitively restored . For deep caries management, stepwise and PCR techniques reportedly result in fewer pulp exposures than traditional one-step total caries removal , and PCR has become an acceptable alternative to either complete caries removal technique if a healthy pulp diagnosis has been established . Concerns with PCR include the risk for residual caries progression, reduced fracture resistance, and possible higher incidence of long-term clinical failure compared to total caries removal techniques . A recent systematic review investigated failures of incompletely excavated teeth and found a higher incidence of pulpal complications relative to non-pulpal . However, 1681 of the 2290 teeth in this investigation were primary teeth, and the authors focused on failure trends rather than a therapeutic advantage of one technique over the other . As there is limited collated information on the outcomes of these techniques in permanent teeth, the purpose of this systematic review (SR) was to comprehensively determine if permanent teeth with deep dentine caries treated with PCR differed in loss of pulp vitality and/or restorative failures compared to similar teeth treated with SWT. A secondary purpose was to determine the presence or lack of patient-oriented outcomes associated with either deep dentine caries management technique.

2

Methods

An electronic search of the English language literature was independently performed by two investigators (VH and HN). PubMed, Web of Science, Dentistry and Oral Sciences Source, and the Cochrane Library database were accessed between September 2, 2015 and February 19, 2016 to identify clinical studies published between January 1, 1980 and March 1, 2016 that evaluated PCR or SWT in permanent teeth with deep dentine caries. The specific PICO question for this SR was: do patients with deep dentine caries in permanent teeth differ in loss of pulp vitality and/or restorative failures when treated with PCR compared to SWT? Predetermined inclusion criteria were 1) English language; 2) human subjects; 3) permanent teeth; 4) any clinical study published between January 1, 1980 and March 1, 2016; 5) a primary carious lesion that radiographically penetrates >50% dentine thickness beyond the DEJ , and a clinical presentation that suggests complete caries removal in a single visit will create an obvious risk for pulp exposure; and 6) subjects followed for a minimum of two years. The predetermined exclusion study criteria were 1) articles that did not meet inclusion criteria or were unrelated to the objectives of this SR; 2) review or technique articles lacking associated clinical data; 3) articles that did not report pulp vitality or restorative outcomes; 4) studies involving primary teeth only; and 5) article that would not allow extraction of data needed to meet the objectives of this study. Randomized controlled trials, controlled clinical trials, cohort studies, observational and case-series were eligible for inclusion. For longitudinal studies published in different articles, only the most recent report from the study was used. Gray literature was not evaluated, and unpublished information from authors was not sought after or used.

Partial-caries-removal and SWT only were investigated. A tooth with deep dentine caries treated with peripheral caries removal and a definitive restoration in one visit was classified as PCR . If a tooth was provisionally sealed following peripheral caries removal and accessed at a later date for the purpose of clinical assessment before definitive restoration but no further caries was removed, it was also classified as PCR . If a tooth was provisionally sealed following peripheral caries removal and accessed at a later date for the purpose of removing residual caries before definitive restoration, it was classified as SWT. If studies included data on teeth whose pulps were exposed for any reason, those teeth were excluded. Partial-caries removal and SWT procedures are summarized in Fig. 1 .

Workflow for PCR and SWT.

Two outcomes were investigated, restorative failures and loss of pulp vitality. A tooth that required retreatment due to secondary or progressing residual caries, reported fracture of the tooth and/or restoration, or was extracted for any reason was classified as a restorative failure. Loss of pulp vitality was defined as a tooth with any clinical or radiographic sign or symptom consistent with an irreversibly diseased or necrotic pulp following treatment. The electronic search and data analysis was conducted in four stages, and a PRISMA format was used to ensure that the process was systematic and complete . In the first stage of the search, two authors (VH and HN) independently screened titles using the search terms and limits listed in Table 1 . If the application of inclusion criteria was not clear or there was disagreement between investigators, the disputed article was included for consideration in the second stage of the search. In the second stage of the search, the same two investigators independently analyzed abstracts of selected titles using a checklist. If there was uncertainty regarding an abstract, the article was included in the third stage, which was a full-text review. In the full-text review, the same two investigators used a spreadsheet to make certain that eligibility criteria were satisfied, and that the quantitative outcomes of interest were reported and retrievable ( Table 2 ). Included in this stage was a manual search of the references of selected articles to identify additional studies for consideration. In the final fourth stage of the investigation, the same two reviewers independently extracted and analyzed data ( Table 3 ), and classified each investigation based on study quality and design .

One of two methodological quality-assessment tools was used to assess risk of bias. For RCT’s, the methodological quality of the trials (i.e. method for randomization, allocation concealment, blinding of participants and outcome assessment, management of incomplete data, selective reporting, and other sources of bias) was assessed using the Cochrane Collaboration risk of bias assessment tool . For observational studies, the methodological quality was assessed using a modified version of the Newcastle-Ottawa scale (NOS) . It was specifically adapted to support the objectives of this review to assess the effect of PCR and SWT on loss of pulp vitality and restorative failures. Topics of consideration included 1) selection of study groups: sample size calculation; comparability of study population to community population; presence of a control group; method to assess pretreatment pulp vitality; clear definition of deep dentine caries; calibration of investigators; clear description of data collection and inclusion/exclusion criteria 2) comparability: comparability of patients in groups based upon study design; management of confounders 3) outcome: pulp vitality and restorative failures were reported; valid diagnostic measures were used to determine outcomes of interest; patient follow-up was adequate 4) statistical analysis: appropriate statistical design; unit of analysis. A star was assigned to each domain if methodological quality was fulfilled, for a maximum of fourteen stars per study. Studies with 11–14 stars were high quality, 8–10 points medium quality, and <8 points were of low quality .

2

Methods

An electronic search of the English language literature was independently performed by two investigators (VH and HN). PubMed, Web of Science, Dentistry and Oral Sciences Source, and the Cochrane Library database were accessed between September 2, 2015 and February 19, 2016 to identify clinical studies published between January 1, 1980 and March 1, 2016 that evaluated PCR or SWT in permanent teeth with deep dentine caries. The specific PICO question for this SR was: do patients with deep dentine caries in permanent teeth differ in loss of pulp vitality and/or restorative failures when treated with PCR compared to SWT? Predetermined inclusion criteria were 1) English language; 2) human subjects; 3) permanent teeth; 4) any clinical study published between January 1, 1980 and March 1, 2016; 5) a primary carious lesion that radiographically penetrates >50% dentine thickness beyond the DEJ , and a clinical presentation that suggests complete caries removal in a single visit will create an obvious risk for pulp exposure; and 6) subjects followed for a minimum of two years. The predetermined exclusion study criteria were 1) articles that did not meet inclusion criteria or were unrelated to the objectives of this SR; 2) review or technique articles lacking associated clinical data; 3) articles that did not report pulp vitality or restorative outcomes; 4) studies involving primary teeth only; and 5) article that would not allow extraction of data needed to meet the objectives of this study. Randomized controlled trials, controlled clinical trials, cohort studies, observational and case-series were eligible for inclusion. For longitudinal studies published in different articles, only the most recent report from the study was used. Gray literature was not evaluated, and unpublished information from authors was not sought after or used.

Partial-caries-removal and SWT only were investigated. A tooth with deep dentine caries treated with peripheral caries removal and a definitive restoration in one visit was classified as PCR . If a tooth was provisionally sealed following peripheral caries removal and accessed at a later date for the purpose of clinical assessment before definitive restoration but no further caries was removed, it was also classified as PCR . If a tooth was provisionally sealed following peripheral caries removal and accessed at a later date for the purpose of removing residual caries before definitive restoration, it was classified as SWT. If studies included data on teeth whose pulps were exposed for any reason, those teeth were excluded. Partial-caries removal and SWT procedures are summarized in Fig. 1 .

Workflow for PCR and SWT.

Two outcomes were investigated, restorative failures and loss of pulp vitality. A tooth that required retreatment due to secondary or progressing residual caries, reported fracture of the tooth and/or restoration, or was extracted for any reason was classified as a restorative failure. Loss of pulp vitality was defined as a tooth with any clinical or radiographic sign or symptom consistent with an irreversibly diseased or necrotic pulp following treatment. The electronic search and data analysis was conducted in four stages, and a PRISMA format was used to ensure that the process was systematic and complete . In the first stage of the search, two authors (VH and HN) independently screened titles using the search terms and limits listed in Table 1 . If the application of inclusion criteria was not clear or there was disagreement between investigators, the disputed article was included for consideration in the second stage of the search. In the second stage of the search, the same two investigators independently analyzed abstracts of selected titles using a checklist. If there was uncertainty regarding an abstract, the article was included in the third stage, which was a full-text review. In the full-text review, the same two investigators used a spreadsheet to make certain that eligibility criteria were satisfied, and that the quantitative outcomes of interest were reported and retrievable ( Table 2 ). Included in this stage was a manual search of the references of selected articles to identify additional studies for consideration. In the final fourth stage of the investigation, the same two reviewers independently extracted and analyzed data ( Table 3 ), and classified each investigation based on study quality and design .

Table 1

Search strategy as used for PubMed.

#1 Search	(stepwise excavation)
#2 Search	(deep caries) AND (survival)
#3 Search	(deep caries) AND (outcome)
#4 Search	(deep caries) AND (vitality)
#5 Search	(indirect pulp) AND (survival)
#6 Search	(deep caries) AND (permanent) AND (outcome)
#7 Search	(complete caries) AND (partial caries) AND (outcome)
#8 Search	(complete caries) AND (partial caries) and (permanent)
#9 Search	(indirect pulp) AND (permanent) and (outcome)
#10 Search	(stepwise) AND (partial caries)
#11 Search	(stepwise) AND (deep caries) AND (permanent)
#12 Search	(incomplete caries) AND (outcome)
#13 Search	(deep caries) AND (excavation)

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