Randomisiert-kontrollierte klinische Studien zu plastischen Restaurationsmaterialien: Ergebnisse und Validität

Das Legen von plastischen Restaurationen ist eine der am häufigsten durchgeführten zahnmedizinischen Behandlungsmaßnahmen. Die Vielzahl der hierfür zur Verfügung stehenden Restaurationsmaterialien stellt Zahnärzte im Praxisalltag vor Herausforderungen beim Therapieentscheid: Obwohl die meisten Materialien in klinischen Studien untersucht worden sind, ist es bisher nicht möglich, eine klare Aussage darüber zu treffen, bei welcher Materialklasse unter einer gegebenen Indikation die höchste klinische Erfolgswahrscheinlichkeit erwartet werden kann. Mit den hier vorgestellten Untersuchungen wurde ein Gesamtbild über die Evidenz zum klinischen Erfolg von plastischen Restaurationsmaterialien und Adhäsivsystemen basierend auf Daten aus Randomisiert-kontrollierten klinischen Studien (RCTs) erstellt. Zur Evidenzsynthese kamen dabei unterschiedliche Verfahren zum Einsatz, die auf Netzwerk-Analysen beruhen. Wir konnten zeigen, dass bei nicht-kariösen Zahnhalsdefekten Kunststoff-modifizierter GIZ die höchste Erfolgswahrscheinlichkeit aufweist. Für kaubelastete Seitenzahnkavitäten haben konventionelle Komposite und Bulk-Fill-Komposite die höchste Erfolgswahrscheinlichkeit. Etch-and-Rinse-Adhäsive haben bei bleibenden Zähnen insgesamt eine höhere Erfolgswahrscheinlichkeit als selbstätzende Adhäsivsysteme. Bei Milchzähnen sind dagegen selbstätzende Adhäsivsysteme gleichermaßen effektiv. Die Art der Klassifikation von Kompositen kann dazu führen, dass einzelne Materialien eine unterschiedliche Position im Ranking gemäß ihrer Erfolgswahrscheinlichkeit in Netzwerk-Metaanalysen einnehmen. Die Rankings von Kompositen wurden unter Anwendung verschiedener Klassifikationssysteme verglichen. Wir fanden eine weitgehende Übereinstimmung zwischen den meisten Klassifikationsmöglichkeiten. Der Vergleich der klinischen Performance von Kompositen basierend auf jährlichen Verlustraten kann jedoch zu falschen Schlussfolgerungen führen, da diese stark von der Nachbeobachtungszeit der zugrunde liegenden Studien abhängen. Wir evaluierten zudem die Studienqualität von RCTs zur Restaurationsmaterialien und Adhäsivsystemen. Ein Großteil dieser RCTs wies ein hohes Risiko für systematische Verzerrungen auf. Darüber hinaus schlossen die untersuchten RCTs zu geringe Patientenzahlen ein und verfolgten diese über zu kurze Zeiträume, um robuste Aussagen zu den Materialien treffen zu können. Viele RCTs sind zudem nicht registriert. Zwar fanden wir auch Verbesserungen über die Zeit, insgesamt ist jedoch die Qualität von vielen RCTs zu Restaurationsmaterialien und Adhäsivsystemen auf einem relativ niedrigen Niveau. Die Wahl der Vergleichsgruppen kann ebenfalls den Beitrag von RCTs zur Gesamtevidenz beeinflussen. Mit einer sozialen Netzwerk-Analyse untersuchten wir die Struktur von Netzwerken gebildet aus Vergleichsgruppen und Vergleichen, die in RCTs zu Restaurationsmaterialien und/oder Adhäsivsystemen durchgeführt worden sind. Bestimmte Materialklassen wurden häufiger als andere Materialklassen als Vergleichsgruppen verwendet. In jüngerer Zeit wurden zunehmend neue Materialentwicklungen als Vergleichsgruppen genutzt. Die Gefahr von Verzerrungen durch die Wahl der Vergleichsgruppen war für RCTs zu Restaurationsmaterialien und Adhäsivsystemen gering. Des Weiteren untersuchten wir den Einfluss von Industrieförderung auf Design, Wahl der Vergleichsgruppen und Ergebnisse bei RCTs zu Restaurationsmaterialien und Adhäsivsystemen. Gesponserte und nicht-gesponserte Studien unterschieden sich bei den meisten Parametern nicht wesentlich voneinander. Daher scheinen die untersuchten RCTs nicht systematisch durch Industrieförderung beeinflusst worden zu sein. Die bisher verfügbare Evidenz aus RCTs ist sowohl quantitativ als auch qualitativ nicht ausreichend, um die relative klinische Erfolgswahrscheinlichkeit der meisten Restaurationsmaterialien und Adhäsivsysteme bewerten zu können. Daher besteht weiterhin Bedarf an klinischen Daten aus Studien mit validem Studiendesign

Probiotic Effects on Multispecies Biofilm Composition, Architecture, and Caries Activity In Vitro

While probiotics have been tested for their anti-caries effect in vitro and also clinically, there is a lack of understanding of their effects on complex dental biofilms. We assessed two probiotics, Lactobacillus reuteri and Streptococcus oligofermentans, on a continuous-cultured model containing Streptococcus mutans, Lactobacillus rhamnosus and Actinomyces naeslundii. Cariogenic biofilms were grown on bovine enamel specimens and daily challenged with L. reuteri or S. oligofermentans whole culture (LC/SC) or cell-free supernatant (LS/SS) or medium only (negative control, NC) (n = 21/group) for 10 days. Biofilm was assessed via counting colony-forming units, quantitative polymerase chain reaction, and fluorescence in situ hybridization. Caries activity was determined by pH measurements and by assessing mineral loss (ΔZ) using transverse microradiography. Both LC and SC significantly reduced total and strain-specific cariogenic bacterial numbers (p < 0.05). ΔZ was reduced in LC (mean ± SD: 1846.67 ± 317.89) and SC (3315.87 ± 617.30) compared to NC (4681.48 ± 495.18, p < 0.05). No significant reductions in bacterial numbers and ΔZ was induced by supernatants. Biofilm architecture was not considerably affected by probiotic applications. Viable probiotics L. reuteri and S. oligofermentans, but not their culture supernatants, could reduce the caries activity of multi-species biofilms in vitro

Comparator choice in cariology trials limits conclusions on the comparative effectiveness of caries interventions

Comparator choice has been found one major factor impacting on the overall evidence supporting clinical interventions. We performed social network analysis on trials on the prevention/management of caries/carious lesions, hypothesizing that certain comparators are proportionally over-investigated, and others under-investigated, and that comparisons within comparator classes are preferred over comparisons between classes. A systematic review of randomized controlled trials on the prevention/management of caries/existing carious lesions was carried out. All comparators were classified at each of three levels of granularity, becoming more detailed with each level; (a) degree of invasiveness (non-, micro- or invasive), (b) the specific non-invasive, micro-invasive or invasive approach, (c) the actual material or technique used. Social network analysis was used to evaluate trial networks. Searching electronic databases found 4,774 articles of which 765 were relevant and 605 were included. The networks for all levels were polygonal. There was a high degree of separation of comparisons in prevention versus management trials. Invasive comparators were tested most frequently (number of comparators: 611), mainly in management trials. Non-invasive comparators were tested next often (474), mainly in caries prevention. Micro-invasive strategies were tested next often (233), in both prevention and management trials. On more granular levels, few interventions dominated the networks. Regardless of the level, the majority of trials compared within, not between classes. Prevention trials were mainly conducted in children (number of trials in adults/children/both: 37/241/11), while those on managing lesions were conducted in both children and adults (117/179/21). Comparator choice in cariology trials is driven by indication, and limits conclusions on the true comparative effectiveness of all strategies. There are a variety of comparators that have not been, but should be, compared to one another, which should be addressed by future trials. Factors underlying trialists’ comparator choice need to be identified

Implementation of COVID-19 Infection Control Measures by German Dentists: A Qualitative Study to Identify Enablers and Barriers

Objectives: COVID-19 infection control measures have been recommended for dental practices worldwide. This qualitative study explored barriers and enablers for the implementation of these measures in German dental practices. Methods: Semi-structured phone interviews were conducted in November/December 2020 (purposive/snowball sampling). The Theoretical Domains Framework (TDF) and the Capabilities, Opportunities and Motivations influencing Behaviors model (COM-B) were used to guide interviews. Mayring's content analysis was employed to analyze interviews. Results: All dentists (28-71 years, 4/8 female/male) had implemented infection control measures. Measures most frequently not adopted were FFP2 masks, face shields (impractical), the rotation of teams (insufficient staffing) and the avoidance of aerosol-generating treatments. Dentists with personal COVID-19 experience or those seeing themselves as a role model were more eager to adopt measures. We identified 34 enablers and 20 barriers. Major barriers were the lack of knowledge, guidelines and recommendations as well as limited availability and high costs of equipment. Pressure by staff and patients to ensure infection control was an enabler. Conclusions: Dentists are motivated to implement infection control measures, but lacking opportunities limited the adoption of certain measures. Policy makers and equipment manufacturers should address these points to increase the implementation of infection control measures against COVID-19 and potential future pandemics

Accuracy of different approaches for detecting proximal root caries lesions in vitro

Objectives: The objective was to evaluate the diagnostic accuracy of radiographic evaluation (XR), visual-tactile assessment (VT), laser-fluorescence (LF) (DIAGNOdent Pen/KaVo), and near-infrared-light transillumination (NILT) (DIAGNOcam/KaVo) on proximal root caries lesions in vitro. Methods: Two-hundred extracted permanent premolars and molars with and without proximal root caries lesions were allocated to 50 diagnostic models simulating the proximal contacts between teeth and mounted in a phantom dummy head. Two independent examiners used the diagnostic approaches to detect any or advanced root caries lesions, with histologic evaluation of the lesions serving as reference. Receiver operating characteristic (ROC) curves were employed, and sensitivity, specificity, and the area under the ROC curve (AUC) are calculated. Significant differences in mean AUCs between approaches were assumed if p < 0.05 (two-sample t-test). Results: NILT was not applicable for proximal root caries detection. The sensitivity/specificity to detect any lesions was 0.81/0.63 for XR, 0.76/0.88 for VT and 0.81/0.95 for LF, and the sensitivity/specificity to detect advanced lesions was 0.43/0.94 for XR, 0.66/0.99 for VT, and 0.83/0.78 for LF, respectively. For both, any and advanced root caries lesions, mean AUCs for LF and VT were significantly higher compared to XR (p < 0.05). For any root caries lesions, LF was significantly more accurate than VT (p = 0.01), but not for advanced root caries lesions (p = 0.59). Conclusions: Under the in vitro conditions chosen, LF and VT were more accurate than XR to detect proximal root caries lesions, with LF being particularly useful for initial lesion stages. Clinical relevance: LF might be a useful diagnostic aid for proximal root caries diagnosis. Clinical studies are necessary to corroborate the findings

Health policy analysis on barriers and facilitators for better oral health in German care homes: a qualitative study

Objectives: To assess possible health policy interventions derived from the theoretical domains framework (TDF) by studying barriers and facilitators on the delivery of oral healthcare and oral hygiene in German care homes using a behavioural change framework. Design: Qualitative correlational study to evaluate a national intervention programme. Setting: Primary healthcare in two care homes in rural Germany. Participants Eleven stakeholders participating in the delivery of oral healthcare (hygiene, treatment) to older people, including two care home managers, four section managers, two nurses/carers and three dentists. Interventions Semistructured interviews conducted in person in the care homes or by phone. A questionnaire developed along the domains of the TDF and the Capabilities, Opportunities and Motivations influencing Behaviours model was used to guide the interviews. Interviews were transcribed and systematised using Mayring’s content analysis along the TDF. Results 860 statements were collected. We identified 19 barriers, facilitators and conflicting themes related to capabilities, 34 to opportunities and 24 to motivation. The lack of access to professional dental care was confirmed by all stakeholders as a major limitation hampering better oral health. Primary outcome A range of interventions can be discussed with the methodology we utilised. In our interviews, lack of dentists willing to treat patients at these facilities was the most discussed barrier for improving oral health of nursing home residents. Secondary outcomes Dentists highlighted the need for better incentives and facilities to deliver oral healthcare in these institutions. Differences with urban settings regarding access to healthcare were frequently discussed by our study participants. Conclusions: Within our sample, greater capacitation of care home staff, better financial incentives for dentists and increased cooperation between the two stakeholders should be considered when designing interventions to tackle oral health of care home residents in Germany

Outcomes in randomised controlled trials in prevention and management of carious lesions:a systematic review

Abstract Background Inconsistent outcome reporting is one significant hurdle to combining results from trials into systematic reviews. Core outcome sets (COS) can reduce this barrier. The aim of this review was to map outcomes reported in caries prevention and management randomised controlled trials (RCT) as a first step to COS development. We also investigated RCT characteristics and reporting of primary outcomes and sample size calculations. Methods PubMed, Embase, Web of Knowledge and Cochrane CENTRAL were systematically searched (1 January 1968 to 25 August 2015). Inclusion criteria: RCTs comparing any technique for prevention or management of caries with another or placebo and RCTs comparing interventions to support patients undergoing treatment of caries (without setting, dentition or age restrictions). Categories were developed through piloting and group consensus and outcomes grouped accordingly. Results Of 4773 search results, 764 were potentially relevant, full text was available for 731 papers and 605 publications met the inclusion criteria and were included. For all outcomes across the time periods 1968–1980 and 2001–2010, reporting of outcome ‘caries experience’ reduced from 39% to 18%; ‘clinical performance of the restoration’ reporting increased from 33% to 42% although there was a reduction to 22% in 2011–2015. Emerging outcome domains include ‘lesion activity’ and ‘pulp health-related outcomes’, accounting for 1% and 0%, respectively, during 1968–1980 and 10% and 4% for 2011–2015. Reporting ‘resource efficiency’ and ‘quality of life measures’ have remained at a low level. No publications reported tooth survival independent of an index such as DMFT or equivalent. Primary outcomes were only identified as such in 414 (68%) of the reports. Conclusions Over the past 50 years, outcome reporting for trials on prevention and management of carious lesions have tended to focus on outcomes measuring caries experience and restoration material clinical performance with lesion activity and cost-effectiveness increasingly being reported. Patient-reported and patient-focused outcomes are becoming more common (although as secondary outcomes) but remain low in use. The challenge with developing a COS will be balancing commonly previously reported outcomes against those more relevant for the future. Trial registration PROSPERO, CRD42015025310 . Registered on 14 August 2015, Trials (Schwendicke et al., Trials 16:397, 2015) and COMET initiative online (COMET, 2017)

Design and Validity of Randomized Controlled Dental Restorative Trials

Background: The evidence stemming from trials on restorative materials is shaped not only by trial findings, but also trial design and validity. We aimed to evaluate both aspects in randomized controlled dental restorative trials published from 2005–2015. Methods: Using systematic review methodology, we retrieved trials comparing restorative or adhesive dental materials. Two authors independently assessed design, risk of bias, registration status, and findings of trials. Descriptive and regression analyses were performed. Results: 114 studies on 15,321 restorations placed mainly in permanent teeth of 5232 patients were included. Per trial, the median number of patients was 37 (25th/75th percentiles: 30/51). Follow-up was 24 (20/48) months. Seventeen percent of trials reported on sample size calculations, 2% had been registered. Most trials (90%) used US Public Health Service (USPHS) criteria, and had a high risk of bias. More recent trials were more likely to have been registered, to have reported on sample size calculations, to be of low risk of bias, and to use other than USPHS-criteria. Twenty-three percent of trials yielded significant differences between groups. The likelihood of such differences was significantly increased in older studies, studies with potential reporting bias, published in journals with high impact factor (&gt;2), longer follow-up periods, and not using USPHS-criteria. Conclusions: The majority of dental restorative trials published from 2005–2015 had limited validity. Risk of bias decreased in more recent trials. Future trials should aim for high validity, be registered, and use defined and appropriate sample sizes, follow-up periods, and outcome measures