Ruth M. Santamaría

Caries Management Strategies for Primary Molars: 1-Yr Randomized Control Trial Results

Minimal invasive approaches to managing caries, such as partial caries removal techniques, are showing increasing evidence of improved outcomes over the conventional complete caries removal. There is also increasing interest in techniques where no caries is removed. We present the 1-yr results of clinical efficacy for 3 caries management options for occlusoproximal cavitated lesions in primary molars: conventional restorations (CR; complete caries removal and compomer restoration), Hall technique (HT; no caries removal, sealing in with stainless steel crowns), and nonrestorative caries treatment (NRCT; no caries removal, opening up the cavity, teaching brushing and fluoride application). In sum, 169 children (3-8 yr old; mean, 5.56 ± 1.45 yr) were enrolled in this secondary care–based, 3-arm, parallel-group, randomized clinical trial. Treatments were carried out by specialist pediatric dentists or postgraduate trainees. One lesion per child received CR, HT, or NRCT. Outcome measures were clinical failure rates, grouped as minor failure (restoration loss/need for replacement, reversible pulpitis, caries progression, etc.) and major failure (irreversible pulpitis, abscess, etc.). There were 148 children (87.6%) with a minimum follow-up of 11 mo (mean, 12.23 ± 0.98 mo). Twenty teeth were recorded as having at least 1 minor failure: NRCT, n = 8 (5%); CR, n = 11 (7%); HT, n = 1 (1%) (p = .002, 95% CI = 0.001 to 0.003). Only the comparison between NRCT and CR showed no significant difference (p = .79, 95% CI = 0.78 to 0.80). Nine (6%) experienced at least 1 major failure: NRCT, n = 4 (2%); CR, n = 5 (3%); HT, n = 0 (0%) (p = .002, 95% CI = 0.001 to 0.003). Individual comparison of NRCT and CR showed no statistically significant difference in major failures (p = .75, 95% CI = 0.73 to 0.76). Success and failure rates were not significantly affected by pediatric dentists’ level of experience (p = .13, 95% CI = 0.12 to 0.14). The HT was significantly more successful clinically than NRCT and CR after 1 yr, while pairwise analyses showed comparable results for treatment success between NRCT and CR (ClinicalTrials.gov NCT01797458).

Selective or stepwise removal of deep caries in deciduous molars: study protocol for a randomized controlled trial

BackgroundFor treating deep caries lesions, selective or stepwise (one- and two-step) incomplete excavation seems advantageous compared with complete caries removal. However, current evidence regarding the success, as defined by not requiring any retreatments, or survival of teeth after different excavations is insufficient for definitive recommendation, especially when treating deciduous teeth. Moreover, restoration integrity has not been comparatively analyzed longitudinally, and neither patients’, dentists’ or parents’ preferences nor the clinical long-term costs emanating from both initial and retreatments have been reported yet.Methods/DesignThe planned study is a prospective multicenter, two-arm parallel group, randomized controlled clinical trial comparing selective and stepwise excavation in deciduous molars with deep, active caries lesions without pulpal symptoms. We will recruit 300 children aged between three and nine-years-old with a minimum of one such molar. Patients participating in another study, or those with systemic diseases, disabilities or known allergies to used materials as well patients with teeth expected to exfoliate within the next 18 months will be excluded. After inclusion, sequence generation will be performed. Initial treatment will follow dental routine. During excavation, leathery, moist and reasonably soft dentin will be left in proximity to the pulp followed by adhesive restoration of the cavity. Afterwards, patients’, dentists’ and parents’ subjective assessment of the treatment will be recorded using visual analogue or Likert scales. Re-examination will be performed after six months, and only then teeth will be allocated to one of the two interventions. Selectively excavated teeth will not be treated further, whilst for stepwise caries removal, a second excavation will be performed until only hard dentin remains. Clinical re-evaluations will be performed after 12, 24 and 36 months. Restorations will be reassessed using modified Ryge criteria. Objectively or subjectively required retreatments will determine success and survival. Retreatments will be evaluated both subjectively and regarding generated costs.DiscussionBased on the results of the trial, decision-making for treating deep caries lesions in deciduous molars based on multiple criteria should be feasible.Trial registrationClinicaltrials.gov identifier: NCT02232828 (registered on 29 November 2014).

Inequalities in dental caries experience among 6-year-old German children after the caries decline.

Abstract Objective. As in many other countries, caries decline in Germany has left pockets of persisting caries prevalence. This study aims to assess the benefit of a 10-year community-based prophylaxis program, focused on regular toothbrushing with fluoridated toothpastes or gels and involving institutions noted as having the highest caries levels. Materials and methods. The caries data (d3mft/D3MFT) was extracted from the results of the compulsory school entry examinations in Greifswald/Germany (2003/2004–2012/2013) involving ∼ 280 6–7-year-olds each year. Data from schools that include children with the highest caries levels and coming from low-SES families were analyzed independently and used for comparisons. Additionally, caries trends from Greifswald were compared to data from representative national surveys (2004–2009). Results. Data from 2871 children were available for analysis. The baseline d3mft value (2003/2004) was 3.2 ± 3.8; the d3-component corresponded to 70% of the index. The latest caries data (2012/2013) showed a strong reduction (43.8%) in caries prevalence (d3mft = 1.8 ± 2.5). Similarly, the SiC-Index declined significantly from 2003/2004 (7.9 ± 2.3) to 2012/2013 (4.8 ± 2.3; p < 0.001). Nevertheless, in all analyzed years the d3mft values and the SiC-Index were significantly higher in the institutions that included children coming from lower-SES families (p < 0.05). The amount of caries reduction between 2004 and 2009 corresponded to 38% in Greifswald as compared to 13% in Germany. Conclusions. This strategy involving a combination of regular toothbrushing and fluoride application has achieved an overall substantial caries reduction, thereby indicating that caries-control strategies for heterogeneous risk groups can be highly successful as setting approach. However, activities targeting high risk groups still need to be strengthened.

Alternative Caries Management Options for Primary Molars: 2.5-Year Outcomes of a Randomised Clinical Trial

Less invasive caries management techniques for treating cavitated carious primary teeth, which involve the concept of caries control by managing the activity of the biofilm, are becoming common. This study aimed to compare the clinical efficacy (minor/major failures) and survival rates (successful cases without any failures) of 3 carious lesion treatment approaches, the Hall Technique (HT), non-restorative caries treatment (NRCT), and conventional restorations (CR), for the management of occlusoproximal caries lesions (ICDAS 3-5) in primary molars. Results at 2.5 years are presented. A total of 169 children (3- to 8-year-olds) were enrolled in this secondary care-based, 3-arm parallel-group, randomised controlled trial. Participants were allocated to: HT (n = 52; sealing caries with stainless-steel crowns without caries removal), NRCT (n = 52; opening up the cavity and applying fluoride varnish), CR (n = 65; control arm, complete caries removal and compomer restoration). Statistical analyses were: non-parametric Kruskal-Wallis analysis of variance, Mann-Whitney U test and Kaplan-Meier survival analyses. One hundred and forty-two participants (84%; HT = 40/52; NRCT = 44/52; CR = 58/65) had follow-up data of 1-33 months (mean = 26). Overall, 25 (HT = 2, NRCT = 9, CR = 14) of 142 participants (17.6%) presented with at least 1 minor failure (reversible pulpitis, caries progression, or secondary caries; p = 0.013, CI = 0.012-0.018; Mann-Whitney U test). Ten (HT = 1, NRCT = 4, CR = 5) of 142 participants (7.04%) experienced at least 1 major failure (irreversible pulpitis, abscess, unrestorable tooth; p = 0.043, CI = 0.034-0.045). Independent comparisons between 2 samples found that NRCT-CR had no statistically significant difference in failures (p > 0.05), but for CR-HT (p = 0.037, CI = 0.030-0.040) and for NRCT-HT (p = 0.011, CI = 0.010-0.016; Kruskal-Wallis test) significant differences were observed. Cumulative survival rates were HT = 92.5%, NRCT = 70.5%, and CR = 67.2% (p = 0.012). NRCT and CR outcomes were comparable. HT performed better than NRCT and CR for all outcomes. This study was funded by the Paediatric Dentistry Department, Greifswald University, Germany (Trial registration No. NCT01797458).

Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel:

Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy. In vitro, self-assembling peptide P11-4 enhances remineralization of early carious lesions. To investigate the safety and clinical efficacy of P11-4 for treatment of initial caries, a randomized controlled single-blind study was conducted on children aged >5 y with visible active early caries on erupting permanent molars. Subjects were randomized to either the test group (P11-4 + fluoride varnish) or control group (fluoride varnish alone). Caries were assessed at baseline and at 3 and 6 mo posttreatment per laser fluorescence, a visual analog scale, the International Caries Detection and Assessment System, and Nyvad caries activity criteria. Intention-to-treat analyses were performed, and safety and clinical feasibility of the treatment approaches were assessed. Compared with the control group, the test group showed clinically and statistically significant improvement in all outcomes at 3 and 6 mo. The laser fluorescence readings (odds ratio = 3.5, P = 0.015) and visual analog scale scores (odds ratio = 7.9, P < .0001) were significantly lower for the test group, and they showed regression in the International Caries Detection and Assessment System caries index (odds ratio = 5.1, P = 0.018) and conversion from active to inactive lesions according to Nyvad criteria (odds ratio = 12.2, P < 0.0001). No adverse events occurred. The biomimetic mineralization facilitated by P11-4 in combination with fluoride application is a simple, safe, and effective noninvasive treatment for early carious lesions that is superior to the presently used gold standard of fluoride alone. By regenerating enamel tissue and preventing lesion progression, this novel approach could change clinical dental practice from a restorative to a therapeutic approach. This could avoid additional loss of healthy hard tissue during invasive restorative treatments, potentially enabling longer tooth life and thereby lowering long-term health costs (ClinicalTrials.gov NCT02724592).

Cost-effectiveness of managing cavitated primary molar caries lesions: A randomized trial in Germany

OBJECTIVES The Hall Technique (HT), Non-Restorative Cavity Control (NRCC) and conventional carious tissue removal and restoration (CR) are strategies for managing cavitated caries lesions in primary molars. A randomized controlled three-arm parallel group trial in a university clinic in Germany was used to measure the cost-effectiveness of these strategies. METHODS 142 children (HT: 40; NRCC: 44; CR: 58) were followed over a mean 2.5 years. A German healthcare perspective was chosen. The primary outcome was estimated molar survival; secondary outcomes were not needing extraction, not having pain or needing endodontic treatment/extraction, or not needing any re-intervention at all. Initial, maintenance and endodontic/restorative/extraction re-treatment costs were derived from fee items of the statutory insurance. Cumulative cost-effectiveness and cost-effectiveness acceptability were estimated from bootstrapped samples. RESULTS HT molars survived longer (estimated mean; 95% CI: 29.7; 26.6-30.5 months) than NRCC (25.3; 21.2-28.7 months) and CR molars (24.1; 22.0-26.2 months). HT was also less costly (66; 62-71 Euro) than NRCC (296; 274-318 Euro) and CR (83; 73-92 Euro). HT was more cost-effective than NRCC and CR in >96% of samples, and had acceptable cost-effectiveness regardless of a payers willingness-to-pay. This superior cost-effectiveness was confirmed for secondary health outcomes. Cost-advantages were even more pronounced when costs were calculated per year of tooth retention (mean annual costs were HT: 29, NRCC: 154, CR: 61 Euro). CONCLUSIONS HT was more cost-effective than CR or NRCC for managing cavitated caries lesions in primary molars, yielding better dental health outcomes at lower costs. CLINICAL SIGNIFICANCE If choosing between these three strategies for managing cavitated caries lesions in primary molars, dentists should prefer HT over NRCC or CR. This would also save costs for the healthcare payer.

Treatment of Carious Lesions Using Self-Assembling Peptides:

Modern approaches in caries treatment involve lesion management without tissue removal. Regenerative medicine focuses on replacing damaged tissues with biologically similar tissues. This article discusses the scientific evidence and clinical results for self-assembling peptides in modern caries management. The biomimetic remineralization promoted by self-assembling peptide P11-4 has been proven in vitro as an effective therapy for initial caries. P11-4 was rationally designed to promote formation of hydroxyapatite on its surface. The formulation was optimized to ensure the ability of monomeric P11-4 to penetrate past the subsurface lesions and assembly into a biomatrix within. Furthermore, P11-4 has shown that it assembles into fibers within carious lesions, and promotes the remineralization thereof. In a recent clinical study, the safety and efficacy of P11-4 in treatment of initial caries were evaluated. The additional effect of the application of P11-4 (Curodont Repair) was compared to the application of fluoride varnish (Duraphat) alone in active occlusal initial caries lesions on erupting permanent molars. In the 3- and 6-month recalls, the test group showed, both in the laser fluorescence readings and in the clinical assessment of the caries stage and activity, significantly superior lesion regression compared to the control group. No adverse events, medical complications, or allergic reactions related to the treatments were reported. Clinical applicability of treatment was regarded as satisfactory. Patients were happy to receive noninvasive caries treatments. In conclusion, biomimetic mineralization facilitated by P11-4 in combination with fluoride may present a simple, safe, and effective noninvasive treatment for early carious lesions.

Trial shows partial caries removal is an effective technique in primary molars.

DesignRandomised controlled trial in a university setting.InterventionChildren aged three to eight years, with at least one molar with an acute, deep carious lesion into the dentine were recruited. Treatment took place under rubber dam with decayed dentine being removed completely from the lateral walls of cavities in both groups using round burs operated at low speed. TCR or PCR was then performed in the pulpal wall of each tooth. After caries removal teeth were restored with calcium hydroxide cement and composite resin. Teeth with pulpal exposure were pulpotomised using ferric sulphate.Outcome measureThe presence of a fistula, swelling, spontaneous pain and mobility not compatible with root resorption were considered to be clinical signs of failure. Radiolucency at the furcation or in the periapical region and internal or external pathological resorption were considered to be radiographic signs of failure.ResultsOne hundred and twenty-four teeth in 51 patients were randomised. In the TCR group there were 57 teeth and 38 patients, with 41 patients and 67 teeth in the PCR group. Three patients (four teeth; one PCR and three TCR) dropped out leaving 120 teeth (PCR: n = 66; TCR: n = 54) for analysis. In the TCR group 27.5% (15) teeth in 13 children had pulp exposure compared with one tooth in one child in the PCR group (2%). The mean operative time was significantly higher for TCR (28.1 min; 95% CI: 23.6–32.6 min) than for PCR (17.9 min; 95% CI: 16.3–19.5 min). There was no statistical difference in success rates at 24 months between the groups. The success rate in the TCR group was 96%; (95% CI: 85–99%) compared with 92%; (95% CI: 81–96%) in the PCR group.ConclusionsThe clinical and radiographic success rates of PCR and TCR in primary teeth with deep carious lesions were high and did not differ significantly, indicating that PCR is a reliable minimally invasive approach in primary teeth and that the retention of carious dentine does not interfere with pulp vitality. Moreover, PCR provided other clinically relevant advantages over TCR, especially lower incidence of pulp exposure and lower operative time.

Sealing Carious Tissue in Primary Teeth Using Crowns: The Hall Technique

In line with reducing the invasiveness of interventions in permanent teeth and changes towards more biological approaches, there have also been moves away from traditional restorative approaches to managing primary teeth where carious dentine/lesions were completely excised and a restoration placed. The Hall Technique is a method for managing carious primary molar teeth where a preformed stainless-steel crown, also known as a preformed metal crown, is seated over a tooth, sealing in, and not removing carious tissue. This chapter discusses the rationale behind the Hall Technique, an outline of the clinical procedure to carry it out, its indications and contraindications, together with the evidence supporting its use. The Hall Technique has been found to be acceptable to children and preferred to more invasive treatment options. Like all dental treatment options, it requires careful case selection, precise carious lesion and pulpal status diagnosis (clinically and radiographically), good patient management, and excellent parental cooperation. The Hall Technique has been shown to be a durable (being likely to last the lifespan of the primary molar) and economical management option for primary molars with carious lesions, which in addition offers the benefit of full coronal coverage, reducing the risk of future carious lesion development. As part of our everyday armamentarium in paediatric dentistry, the Hall Technique is an effective management option for controlling carious lesions in primary molars.

Cost-effectiveness of the Hall Technique in a Randomized Trial:

Clinical and patient-reported outcomes were reported for carious primary molars treated with the Hall technique (HT) as compared with conventional carious tissue removal and restorations (i.e., conventional restoration [CR]) in a 5-y randomized controlled practice-based trial in Scotland. We interrogated this data set further to investigate the cost-effectiveness of HT versus CR. A total of 132 children who had 2 matched occlusal/occlusal-proximal carious lesions in primary molars (n = 264 teeth) were randomly allocated to HT or CR, provided by 17 general dental practitioners. Molars were followed up for a mean 5 y. A societal perspective was taken for the economic analysis. Direct dental treatment costs were estimated from a Scottish NHS perspective (an NHS England perspective was taken for a sensitivity analysis). Initial, maintenance, and retreatment costs, including rerestorations, endodontic treatments, and extractions, were estimated with fee items. Indirect/opportunity costs were estimated with time and travel costs from a UK perspective. The primary outcome was tooth survival. Secondary outcomes included 1) not having pain or needing endodontic treatments/extractions and 2) not needing rerestorations. Cost-effectiveness and acceptability were estimated from bootstrapped samples. Significantly more molars in HT survived (99%, 95% CI: 98% to 100%) than in CR (92%; 87% to 97%). Also, the proportion of molars retained without pain or requiring endodontic treatment/extraction was significantly higher in HT than CR. In the base case analysis (NHS Scotland perspective), cumulative direct dental treatment costs (Great British pound [GBP]) of HT were 24 GBP (95% CI: 23 to 25); costs for CR were 29 (17 to 46). From an NHS England perspective, the cost advantage of HT (29 GBP; 95% CI: 25 to 34) over CR (107; 86 to 127) was more pronounced. Indirect/opportunity costs were significantly lower for HT (8 GBP; 95% CI: 7 to 9) than CR (19; 16 to 23). Total cumulative costs were significantly lower for HT (32 GBP; 95% CI: 31 to 34) than CR (49; 34 to 69). Based on a long-term practice-based trial, HT was more cost-effective than CR with HT retained for longer and experiencing less complications at lower costs.