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searched four bibliographic databases to 21 July 2020 and used additional search methods to identify published, unpublished and ongoing studies.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.

Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT.

BACKGROUND: Historically, lack of evidence for effective management of decay in primary teeth has caused uncertainty, but there is emerging evidence to support alternative strategies to conventional fillings, which are minimally invasive and prevention orientated. OBJECTIVES: The objectives were (1) to assess the clinical effectiveness and cost-effectiveness of three strategies for managing caries in primary teeth and (2) to assess quality of life, dental anxiety, the acceptability and experiences of children, parents and dental professionals, and caries development and/or progression. DESIGN: This was a multicentre, three-arm parallel-group, participant-randomised controlled trial. Allocation concealment was achieved by use of a centralised web-based randomisation facility hosted by Newcastle Clinical Trials Unit. SETTING: This trial was set in primary dental care in Scotland, England and Wales. PARTICIPANTS: Participants were NHS patients aged 3-7 years who were at a high risk of tooth decay and had at least one primary molar tooth with decay into dentine, but no pain/sepsis. INTERVENTIONS: Three interventions were employed: (1) conventional with best-practice prevention (local anaesthetic, carious tissue removal, filling placement), (2) biological with best-practice prevention (sealing-in decay, selective carious tissue removal and fissure sealants) and (3) best-practice prevention alone (dietary and toothbrushing advice, topical fluoride and fissure sealing of permanent teeth). MAIN OUTCOME MEASURES: The clinical effectiveness outcomes were the proportion of children with at least one episode (incidence) and the number of episodes, for each child, of dental pain or dental sepsis or both over the follow-up period. The cost-effectiveness outcomes were the cost per incidence of, and cost per episode of, dental pain and/or dental sepsis avoided over the follow-up period. RESULTS: A total of 72 dental practices were recruited and 1144 participants were randomised (conventional arm, n = 386; biological arm, n = 381; prevention alone arm, n = 377). Of these, 1058 were included in an intention-to-treat analysis (conventional arm, n = 352; biological arm, n = 352; prevention alone arm, n = 354). The median follow-up time was 33.8 months (interquartile range 23.8-36.7 months). The proportion of children with at least one episode of pain or sepsis or both was 42% (conventional arm), 40% (biological arm) and 45% (prevention alone arm). There was no evidence of a difference in incidence or episodes of pain/sepsis between arms. When comparing the biological arm with the conventional arm, the risk difference was -0.02 (97.5% confidence interval -0.10 to 0.06), which indicates, on average, a 2% reduced risk of dental pain and/or dental sepsis in the biological arm compared with the conventional arm. Comparing the prevention alone arm with the conventional arm, the risk difference was 0.04 (97.5% confidence interval -0.04 to 0.12), which indicates, on average, a 4% increased risk of dental pain and/or dental sepsis in the prevention alone arm compared with the conventional arm. Compared with the conventional arm, there was no evidence of a difference in episodes of pain/sepsis among children in the biological arm (incident rate ratio 0.95, 97.5% confidence interval 0.75 to 1.21, which indicates that there were slightly fewer episodes, on average, in the biological arm than the conventional arm) or in the prevention alone arm (incident rate ratio 1.18, 97.5% confidence interval 0.94 to 1.48, which indicates that there were slightly more episodes in the prevention alone arm than the conventional arm). Over the willingness-to-pay values considered, the probability of the biological treatment approach being considered cost-effective was approximately no higher than 60% to avoid an incidence of dental pain and/or dental sepsis and no higher than 70% to avoid an episode of pain/sepsis. CONCLUSIONS: There was no evidence of an overall difference between the three treatment approaches for experience of, or number of episodes of, dental pain or dental sepsis or both over the follow-up period. FUTURE WORK: Recommendations for future work include exploring barriers to the use of conventional techniques for carious lesion detection and diagnosis (e.g. radiographs) and developing and evaluating suitable techniques and strategies for use in young children in primary care. TRIAL REGISTRATION: Current Controlled Trials ISRCTN77044005. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 1. See the NIHR Journals Library website for further project information.

WHAT WAS THE QUESTION?: Tooth decay is common; it can lead to pain, days off school for children and days off work for parents and is a financial burden to the NHS. There is uncertainty about the best way of managing decay in young children. This trial aimed to find out whether or not there was a difference in the amount of pain and/or infection suffered by children having their decay treated with one of the following: fillings, having decay sealed in or using preventative treatment alone. Which method represented the best value was also explored. WHAT DID WE DO?: For young children with decay, the Filling Children's Teeth: Indicated Or Not? (FiCTION) trial compared the difference between fillings, sealing in the decay and using preventative treatment alone over 3 years in NHS dental practices in Scotland, England and Wales. We recruited 1144 children aged 3­7 years with one or more holes in their baby back teeth (molars), but without pain/infection, and placed them at random into one of three groups: (1) tooth numbing, removing decay and filling(s) with preventative treatment; (2) sealing in decay with fillings or caps and preventative treatment but no numbing; or (3) preventative treatment alone. WHAT DID WE FIND?: Recruitment was challenging but was achieved. There was no evidence of a difference in children's experience of pain or infection, quality of life or dental anxiety between groups. All three ways of treating decay were acceptable to children, parents and dental professionals. Sealing in with preventative treatment was most likely to be considered the best way of managing children's decay if we are willing to pay a minimum of £130 to avoid an episode of pain or infection. WHAT DOES THIS MEAN?: As there was no evidence of a difference between the three treatment groups in pain/infection experienced, treatment choice should continue to be based on shared decision-making between the child, parent and clinician to agree the best option for the individual child.

WITHDRAWN: Operative caries management in adults and children.

BACKGROUND: The management of dental caries has traditionally involved removal of all soft demineralised dentine before a filling is placed. However, the benefits of complete caries removal have been questioned because of concerns about the possible adverse effects of removing all soft dentine from the tooth. Three groups of studies have also challenged the doctrine of complete caries removal by sealing caries into teeth using three different techniques. The first technique removes caries in stages over two visits some months apart, allowing the dental pulp time to lay down reparative dentine (the stepwise excavation technique). The second removes part of the dentinal caries and seals the residual caries into the tooth permanently (partial caries removal) and the third technique removes no dentinal caries prior to sealing or restoring (no dentinal caries removal). This is an update of a Cochrane review first published in 2006. OBJECTIVES: To assess the effects of stepwise, partial or no dentinal caries removal compared with complete caries removal for the management of dentinal caries in previously unrestored primary and permanent teeth. SEARCH METHODS: The following electronic databases were searched: the Cochrane Oral Health Group's Trials Register (to 12 December 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 11), MEDLINE via OVID (1946 to 12 December 2012) and EMBASE via OVID (1980 to 12 December 2012). There were no restrictions regarding language or date of publication. SELECTION CRITERIA: Parallel group and split-mouth randomised and quasi-randomised controlled trials comparing stepwise, partial or no dentinal caries removal with complete caries removal, in unrestored primary and permanent teeth were included. DATA COLLECTION AND ANALYSIS: Three review authors extracted data independently and in triplicate and assessed risk of bias. Trial authors were contacted where possible for information. We used standard methodological procedures exacted by The Cochrane Collaboration. MAIN RESULTS: In this updated review, four new trials were included bringing the total to eight trials with 934 participants and 1372 teeth. There were three comparisons: stepwise caries removal compared to complete one stage caries removal (four trials); partial caries removal compared to complete caries removal (three trials) and no dentinal caries removal compared to complete caries removal (two trials). (One three-arm trial compared complete caries removal to both stepwise and partial caries removal.) Four studies investigated primary teeth, three permanent teeth and one included both. All of the trials were assessed at high risk of bias, although the new trials showed evidence of attempts to minimise bias.Stepwise caries removal resulted in a 56% reduction in incidence of pulp exposure (risk ratio (RR) 0.44, 95% confidence interval (CI) 0.33 to 0.60, P < 0.00001, I2 = 0%) compared to complete caries removal based on moderate quality evidence, with no heterogeneity. In these four studies, the mean incidence of pulp exposure was 34.7% in the complete caries removal group and 15.4% in the stepwise groups. There was also moderate quality evidence of no difference in the outcome of signs and symptoms of pulp disease (RR 0.78, 95% CI 0.39 to 1.58, P = 0.50, I2 = 0%).Partial caries removal reduced incidence of pulp exposure by 77% compared to complete caries removal (RR 0.23, 95% CI 0.08 to 0.69, P = 0.009, I2 = 0%), also based on moderate quality evidence with no evidence of heterogeneity. In these two studies the mean incidence of pulp exposure was 21.9% in the complete caries removal groups and 5% in the partial caries removal groups. There was insufficient evidence to determine whether or not there was a difference in signs and symptoms of pulp disease (RR 0.27, 95% CI 0.05 to 1.60, P = 0.15, I2 = 0%, low quality evidence), or restoration failure (one study showing no difference and another study showing no failures in either group, very low quality evidence).No dentinal caries removal was compared to complete caries removal in two very different studies. There was some moderate evidence of no difference between these techniques for the outcome of signs and symptoms of pulp disease and reduced risk of restoration failure favouring no dentinal caries removal, from one study, and no instances of pulp disease or restoration failure in either group from a second quasi-randomised study. Meta-analysis of these two studies was not performed due to substantial clinical differences between the studies. AUTHORS' CONCLUSIONS: Stepwise and partial excavation reduced the incidence of pulp exposure in symptomless, vital, carious primary as well as permanent teeth. Therefore these techniques show clinical advantage over complete caries removal in the management of dentinal caries. There was no evidence of a difference in signs or symptoms of pulpal disease between stepwise excavation, and complete caries removal, and insufficient evidence to determine whether or not there was a difference in signs and symptoms of pulp disease between partial caries removal and complete caries removal. When partial caries removal was carried out there was also insufficient evidence to determine whether or not there is a difference in risk of restoration failure. The no dentinal caries removal studies investigating permanent teeth had a similar result with no difference in restoration failure. The other no dentinal caries removal study, which investigated primary teeth, showed a statistically significant difference in restoration failure favouring the intervention.Due to the short term follow-up in most of the included studies and the high risk of bias, further high quality, long term clinical trials are still required to assess the most effective intervention. However, it should be noted that in studies of this nature, complete elimination of risk of bias may not necessarily be possible. Future research should also investigate patient centred outcomes.