Interventions for treating cavitated or dentine carious lesions.

BACKGROUND: Traditionally, cavitated carious lesions and those extending into dentine have been treated by 'complete' removal of carious tissue, i.e. non-selective removal and conventional restoration (CR). Alternative strategies for managing cavitated or dentine carious lesions remove less or none of the carious tissue and include selective carious tissue removal (or selective excavation (SE)), stepwise carious tissue removal (SW), sealing carious lesions using sealant materials, sealing using preformed metal crowns (Hall Technique, HT), and non-restorative cavity control (NRCC). OBJECTIVES: To determine the comparative effectiveness of interventions (CR, SE, SW, sealing of carious lesions using sealant materials or preformed metal crowns (HT), or NRCC) to treat carious lesions conventionally considered to require restorations (cavitated or micro-cavitated lesions, or occlusal lesions that are clinically non-cavitated but clinically/radiographically extend into dentine) in primary or permanent teeth with vital (sensitive) pulps. SEARCH METHODS: An information specialist searched four bibliographic databases to 21 July 2020 and used additional search methods to identify published, unpublished and ongoing studies.  SELECTION CRITERIA: We included randomised clinical trials comparing different levels of carious tissue removal, as listed above, against each other, placebo, or no treatment. Participants had permanent or primary teeth (or both), and vital pulps (i.e. no irreversible pulpitis/pulp necrosis), and carious lesions conventionally considered to need a restoration (i.e. cavitated lesions, or non- or micro-cavitated lesions radiographically extending into dentine). The primary outcome was failure, a composite measure of pulp exposure, endodontic therapy, tooth extraction, and restorative complications (including resealing of sealed lesions). DATA COLLECTION AND ANALYSIS: Pairs of review authors independently screened search results, extracted data, and assessed the risk of bias in the studies and the overall certainty of the evidence using GRADE criteria. We measured treatment effects through analysing dichotomous outcomes (presence/absence of complications) and expressing them as odds ratios (OR) with 95% confidence intervals (CI). For failure in the subgroup of deep lesions, we used network meta-analysis to assess and rank the relative effectiveness of different interventions. MAIN RESULTS: We included 27 studies with 3350 participants and 4195 teeth/lesions, which were conducted in 11 countries and published between 1977 and 2020. Twenty-four studies used a parallel-group design and three were split-mouth. Two studies included adults only, 20 included children/adolescents only and five included both. Ten studies evaluated permanent teeth, 16 evaluated primary teeth and one evaluated both. Three studies treated non-cavitated lesions; 12 treated cavitated, deep lesions, and 12 treated cavitated but not deep lesions or lesions of varying depth.  Seventeen studies compared conventional treatment (CR) with a less invasive treatment: SE (8), SW (4), two HT (2), sealing with sealant materials (4) and NRCC (1). Other comparisons were: SE versus HT (2); SE versus SW (4); SE versus sealing  with sealant materials (2); sealant materials versus no sealing (2).  Follow-up times varied from no follow-up (pulp exposure during treatment) to 120 months, the most common being 12 to 24 months. All studies were at overall high risk of bias. Effect of interventions Sealing using sealants versus other interventions for non-cavitated or cavitated but not deep lesions There was insufficient evidence of a difference between sealing with sealants and CR (OR 5.00, 95% CI 0.51 to 49.27; 1 study, 41 teeth, permanent teeth, cavitated), sealing versus SE (OR 3.11, 95% CI 0.11 to 85.52; 2 studies, 82 primary teeth, cavitated) or sealing versus no treatment (OR 0.05, 95% CI 0.00 to 2.71; 2 studies, 103 permanent teeth, non-cavitated), but we assessed all as very low-certainty evidence. HT, CR, SE, NRCC for cavitated, but not deep lesions in primary teeth The odds of failure may be higher for CR than HT (OR 8.35, 95% CI 3.73 to 18.68; 2 studies, 249 teeth; low-certainty evidence) and lower for HT than NRCC (OR 0.19, 95% CI 0.05 to 0.74; 1 study, 84 teeth, very low-certainty evidence). There was insufficient evidence of a difference between SE versus HT (OR 8.94, 95% CI 0.57 to 139.67; 2 studies, 586 teeth) or CR versus NRCC (OR 1.16, 95% CI 0.50 to 2.71; 1 study, 102 teeth), both very low-certainty evidence. CR, SE, SW for deep lesions The odds of failure were higher for CR than SW in permanent teeth (OR 2.06, 95% CI 1.34 to 3.17; 3 studies, 398 teeth; moderate-certainty evidence), but not primary teeth (OR 2.43, 95% CI 0.65 to 9.12; 1 study, 63 teeth; very low-certainty evidence). The odds of failure may be higher for CR than SE in permanent teeth (OR 11.32, 95% CI 1.97 to 65.02; 2 studies, 179 teeth) and primary teeth (OR 4.43, 95% CI 1.04 to 18.77; 4 studies, 265 teeth), both very low-certainty evidence. Notably, two studies compared CR versus SE in cavitated, but not deep lesions, with insufficient evidence of a difference in outcome (OR 0.62, 95% CI 0.21 to 1.88; 204 teeth; very low-certainty evidence). The odds of failure were higher for SW than SE in permanent teeth (OR 2.25, 95% CI 1.33 to 3.82; 3 studies, 371 teeth; moderate-certainty evidence), but not primary teeth (OR 2.05, 95% CI 0.49 to 8.62; 2 studies, 126 teeth; very low-certainty evidence). For deep lesions, a network meta-analysis showed the probability of failure to be greatest for CR compared with SE, SW and HT. AUTHORS' CONCLUSIONS: Compared with CR, there were lower numbers of failures with HT and SE in the primary dentition, and with SE and SW in the permanent dentition. Most studies showed high risk of bias and limited precision of estimates due to small sample size and typically limited numbers of failures, resulting in assessments of low or very low certainty of evidence for most comparisons.