Mislabeling Controlled Clinical Trials (CCTs) as “Randomized Clinical Trials (RCTs)” in Dental Specialty Journals

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

doi:10.1016/j.jebdp.2012.05.002

Cited by 17 publications

(14 citation statements)

References 30 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A modification of this tool was utilized for the included in-vitro/pre-clinical studies, as no pre-determined guidelines to assess the risk of bias exist and in order to incorporate specific important elements that would help identify the presence of potential bias. These include selection bias [17,18], performance bias [19], attrition bias [20] and reporting issues [21,22].…”

Section: Risk Of Bias Assessment Within Individual Studiesmentioning

confidence: 99%

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

et al. 2020

Self Cite

View full text Add to dashboard Cite

Use of thermoplastic material in orthodontics, either as aligner or as retainer appliances, is common practice and is likely to increase in the years to come. However, no systematic assessment on safety considerations of these adjuncts has been implemented up to date. The aim of this systematic review was to collectively appraise the existing evidence from both clinical and laboratory studies, on whether these appliances are associated with any estrogenic/cytotoxic effects or bisphenol-A (BPA) and monomer leaching. Eight electronic databases were searched with no limits in December 22, 2019, for published and unpublished research. Eligibility criteria comprised of studies of any design, describing use of any type of thermoplastic aligner. Study selection, data extraction and risk of bias (RoB) assessment was done independently, either in duplicate or confirmed by a second reviewer. Random effects meta-analyses of weighted mean differences (WMD) with associated 95% Confidence Intervals (CIs) were planned. Quality of the evidence was evaluated with Grading of Recommendations Assessment, Development and Evaluation (GRADE). A total of 58 articles were initially identified, while 5 were included in qualitative synthesis and 2 of those contributed to the quantitative syntheses. Four studies were in-vitro, while one was a randomized controlled trial; all assessed some type of orthodontic aligner or retainer, either as-received or retrieved. Risk of bias recordings ranged between unclear and high for all studies. Proliferation induction capacity of thermoplastic appliances’ eluents on MCF-7 cells failed to be confirmed compared to beta-estradiol (2 studies: 5% v/v, WMD: −182.08; 95% CI: −198.83, −165.33; p-value < 0.001; and 20% v/v, WMD: −184.53; 95% CI: −206.17, −162.88; p-value < 0.001). No cytotoxic activity was detected as well. In addition, although evidence from in-vitro studies was indicative of no traceable detection of BPA or other monomers, the findings from a single clinical trial were allied to increased levels of BPA in whole stimulated saliva, after up to 30 days of thermoplastic retainer usage, compared to standard Hawley retainer. The quality of the evidence overall was low to medium. Current data from in-vitro research are indicative of an absence of an estrogenic or cytotoxic effect of thermoplastic aligners or retainers. Regarding BPA or monomer release, evidence from clinical and laboratory studies appear inconsistent.

show abstract

Section: Risk Of Bias Assessment Within Individual Studiesmentioning

confidence: 99%

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

et al. 2020

Self Cite

View full text Add to dashboard Cite

show abstract

“…A modification of this tool was utilized for the included in vitro or small in vivo studies, as no pre-determined guidelines to assess the risk of bias exist and in order to incorporate specific important elements that would help identify the presence of potential bias. These include selection bias [15,16], performance bias [17], attrition bias and reporting issues [18,19].…”

Section: Risk Of Bias In Individual Studiesmentioning

confidence: 99%

Particulate Production and Composite Dust during Routine Dental Procedures. A Systematic Review with Meta-Analyses

et al. 2020

Self Cite

View full text Add to dashboard Cite

Composite dust generation is most likely a continuous and daily procedure in dental practice settings. The aim of this systematic review was to identify, compile and evaluate existing evidence on interventions and composite material properties related to the production of aerosolized dust during routine dental procedures. Seven electronic databases were searched, with no limits, supplemented by a manual search, on 27 April 2020 for published and unpublished research. Eligibility criteria comprised of studies of any design, describing composite dust production related to the implementation of any procedure in dental practice. Study selection, data extraction and risk of bias (RoB) assessment was undertaken independently either in duplicate, or confirmed by a second reviewer. Random effects meta-analyses of standardized mean differences (SMD) with associated 95% confidence intervals (CIs) were employed where applicable. A total of 375 articles were initially identified, resulting in 13 articles being included in the qualitative synthesis, of which 5 contributed to meta-analyses overall. Risk of bias recordings ranged between low and high, pertaining to unclear/raising some concerns, in most cases. All types of composites, irrespective of the filler particles, released significant amounts of nano-sized particles after being ground, with potentially disruptive respiratory effects. Evidence supported increased % distribution of particles < 100 nm for nanocomposite Filtek Supreme XTE compared to both conventional hybrid Z100MP (SMD: 1.96, 95% CI: 0.85, 3.07; p-value; 0.001) and nano- hybrid Tetric EvoCeram (SMD: 1.62, 95% CI: 0.56, 2.68; p-value: 0.003). For cytotoxicity considerations of generated aerosolized particles, both nanocomposites Filtek Supreme XTE and nanohybrid GradiO revealed negative effects on bronchial epithelial cell viability, as represented by % formazan reduction at 330–400 μg/mL for 24 hours, with no recorded differences between them (SMD: 0.19; 95% CI: −0.17, 0.55; p-value: 0.30). Effective and more rigorous management of dental procedures potentially liable to the generation of considerable amounts of aerosolized composite dust should be prioritized in contemporary dental practice. In essence, protective measures for the clinician and the practices’ personnel should also be systematically promoted and additional interventions may be considered in view of the existing evidence.

show abstract

“…Randomized clinical trials (RCT) are considered the ‘gold standard’ for assessing intervention effects (Koletsi et al . ). To date, only one RCT evaluating the antimicrobial effect of ultrasonic activation has been reported (Beus et al .…”

Section: Introductionmentioning

confidence: 97%

Effect of ultrasonic activation on the reduction of bacteria and endotoxins in root canals: a randomized clinical trial

et al. 2017

View full text Add to dashboard Cite

Nakamura VC, Pinheiro ET, Prado LC, Silveira AC, Carvalho APL, Mayer MPA, Gavini G. Effect of ultrasonic activation on the reduction of bacteria and endotoxins in root canals: a randomized clinical trial. Journal, 51, e12-e22, 2018. Aim This randomized clinical trial aimed to compare the effectiveness of ultrasonic activation with that of nonactivated irrigation on the removal of bacteria and endotoxin from root canals. Methodology Fifty patients with necrotic pulps and asymptomatic apical periodontitis were randomly allocated into two groups according to the final irrigation protocol after root canal preparation: Group UIultrasonic irrigation (n = 25) and Group NI -needle irrigation (n = 25). The root canals were medicated with calcium hydroxide for 14 days. Microbiological sampling was performed before (S1) and after the root canal preparation (S2), after the irrigation protocols (S3) and after the removal of the intracanal medication (S4). Total bacteria counts were determined by qPCR and the endotoxin levels by the limulus amebocyte lysate assay. Intragroup analyses were performed using the Wilcoxon test for related samples, whereas intergroup analyses were performed using the MannWhitney U-test (P < 0.05). Results All S1 samples were positive for bacteria, with median numbers of 1.49 9 10 6 and 8.55 9 10 5 bacterial cells for the UI and NI groups, respectively. This number significantly decreased in S2 samples (UI: 1.41 9 10 4 ; NI: 3.53 9 10 4 ; both with P < 0.001). After final irrigation protocols, there was a significant decrease in bacterial load from S2 to S3 samples in both groups (UI: 4.29 9 10 3 ; NI: International Endodontic1.08 9 10 4 ; P < 0.01). Intergroup analysis revealed a significant difference between irrigation methods regarding bacterial counts in S3 samples (P < 0.05). In contrast, no significant differences were observed between groups for endotoxin levels (P > 0.05). Conclusions Ultrasonic activation was more effective than nonactivated irrigation for reducing the number of bacteria but not the endotoxin levels in root canals of teeth with apical periodontitis.

show abstract

Mislabeling Controlled Clinical Trials (CCTs) as “Randomized Clinical Trials (RCTs)” in Dental Specialty Journals

Cited by 17 publications

References 30 publications

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research

Particulate Production and Composite Dust during Routine Dental Procedures. A Systematic Review with Meta-Analyses

Effect of ultrasonic activation on the reduction of bacteria and endotoxins in root canals: a randomized clinical trial

Contact Info

Product

Resources

About