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

2017 ◽  
Vol 51 (6) ◽  
pp. 605-614 ◽  
Author(s):  
Ruth M. Santamaría ◽  
N.P.T. Innes ◽  
Vita Machiulskiene ◽  
Julian Schmoeckel ◽  
Mohammad Alkilzy ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Survival Rates ◽  
Randomised Clinical Trial ◽  
Primary Molars ◽  
Management Options ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Caries Management ◽  
Caries Removal ◽  
Randomised Controlled

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).

scholarly journals Caries Management Strategies for Primary Molars

2014 ◽  
Vol 93 (11) ◽  
pp. 1062-1069 ◽  
Author(s):  
R.M. Santamaria ◽  
N.P.T. Innes ◽  
V. Machiulskiene ◽  
D.J.P. Evans ◽  
C.H. Splieth
Keyword(s):  
Treatment Success ◽  
Management Strategies ◽  
Minimal Invasive ◽  
Primary Molars ◽  
Failure Rates ◽  
Management Options ◽  
Significant Difference ◽  
Caries Management ◽  
Pediatric Dentists ◽  
Caries Removal

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).

scholarly journals Survival Rates of Class II Restoration in Primary Molar with Flowable Resin Composite

2021 ◽  
Vol 48 (1) ◽  
pp. 12-20
Author(s):  
Hyejun Seo ◽  
Soyoung Park ◽  
Eungyung Lee ◽  
Taesung Jeong ◽  
Jonghyun Shin
Keyword(s):  
Stainless Steel ◽  
Survival Rate ◽  
Resin Composite ◽  
Survival Rates ◽  
Class Ii ◽  
Primary Molars ◽  
Primary Molar ◽  
Proximal Caries ◽  
Kaplan Meier ◽  
Significant Difference

The purpose of this retrospective study was to evaluate the survival rate by comparing Class II restoration using flowable resin composite with stainless steel crown in primary molars.Electronic medical records and radiographs of 1,504 primary molars with proximal caries of 590 patients from June 2015 to August 2019 were analyzed. With the collected data, survival analysis was performed using the Kaplan-Meier method.The 1-year survival rate of flowable resin composite in the primary molar was 98.5%, 3-year survival rate was 87.7%, and mean survival time was 39 months. There was no statistically significant difference between flowable resin composite and stainless steel crown (<i>p</i> = 0.896).Within the limits of this study, Class II restoration using flowable resin composite can be considered a promising option for the treatment of proximal caries in primary molars.

scholarly journals Universal Adhesives and Adhesion Modes in Non-Carious Cervical Restorations: 2-Year Randomised Clinical Trial

Polymers ◽  
2021 ◽  
Vol 14 (1) ◽  
pp. 33
Author(s):  
Patricia Manarte-Monteiro ◽  
Joana Domingues ◽  
Liliana Teixeira ◽  
Sandra Gavinha ◽  
Maria Conceição Manso
Keyword(s):  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Nonparametric Tests ◽  
Retention Rates ◽  
Cervical Lesions ◽  
Double Blind ◽  
Kaplan Meier ◽  
Etch And Rinse ◽  
Universal Adhesives ◽  
Randomised Controlled

This prospective, double-blind, six-arm parallel randomised controlled trial aimed to compare the performance of two universal adhesives (UAs) in non-carious cervical lesions (NCCLs), using the FDI criteria, and analysed if participants/NCCLs’ characteristics influenced the outcome. Thirty-eight 18- to 65-year-old participants were seeking routine dental care at a university clinic. At baseline, 210 NCCLs were randomly allocated to six groups (35 restorations’ each). The UAs tested were FuturabondU (FBU) and AdheseUniversal (ADU) applied in either etch-and-rinse (ER) and self-etch (SE) modes. FuturabondDC (FBDC) in SE and in SE with selective enamel etching (SE-EE) modes were controls. NCCLs were restored with AdmiraFusion. The analysis included nonparametric tests, Kaplan-Meier and log-rank tests (α = 0.05). At 2-years, of 191 restorations, ten were missed due to retention loss (all groups, p > 0.05). FBDC (p = 0.037) and FBU (p = 0.041) performed worse than ADU in SE mode. FBDC and FBU also showed worse functional success rate (p = 0.012, p = 0.007, respectively) and cumulative retention rates (p = 0.022, p = 0.012, respectively) than ADU. Some participants/NCCLs’ characteristics influenced (p < 0.05) the outcomes. FBU did not perform as well as ADU, especially in SE mode and due to functional properties. Participants’ age and NCCLs’ degree of dentin sclerosis and internal shape angle influenced FBU performance.

Effect of Different Liners on Pulpal Outcome after Partial Caries Removal: A Preliminary 12 Months Randomised Controlled Trial

2019 ◽  
Vol 53 (5) ◽  
pp. 547-554 ◽  
Author(s):  
Shreya Singh ◽  
Shweta Mittal ◽  
Sanjay Tewari
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Permanent Teeth ◽  
Categorical Variables ◽  
Significant Difference ◽  
Caries Removal ◽  
Randomised Controlled ◽  
Analytical Approaches ◽  
Partial Caries Removal

Aim: The aim of this double-blinded parallel randomised controlled trial was to compare the effect of different liners on 12-month pulp health outcomes after partial caries removal (PCR) with composite restorations in permanent molars. Methods: The study was registered at clinicaltrials.gov with registration No. NCT0328695 and conducted in the Department of Conservative dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak with no external financial support. One hundred and ninety-eight participants (116 males, 82 females and age 14–54 years) with vital permanent mature mandibular molars having deep caries involving two-thirds or more of dentin were randomised to calcium hydroxide (CH), resin-modified GIC (RMGIC) and no liner (DC) groups after PCR. After a follow-up time of 12 months, success was defined as positive response to pulp sensibility and absence of periapical alterations. Results: Categorical variables were compared using chi-square test. Two analytical approaches were used, such as intention-to-treat and per-protocol approach. Success rates in per-protocol approach were 96.8, 96.5, and 94.6% for CH, RMGIC and DC groups, respectively with no significant difference between 3 groups (p = 0.811). None of the baseline variables had any significant influence on the treatment success. Conclusion: Partial caries excavation has a high success rate to treat deep carious lesions in permanent teeth after 12 months of follow-up, indicating that the retention of carious dentin does not interfere with pulp vitality or restoration survival. Also, the success of the treatment is independent of the lining material used over the demineralized dentin.

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

scholarly journals The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 1042
Author(s):  
Nicholas Phillips ◽  
Julie Mareschal ◽  
Nathalie Schwab ◽  
Emily Manoogian ◽  
Sylvie Borloz ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Metabolic Health ◽  
Dietary Advice ◽  
Processed Food ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Weight loss is key to controlling the increasing prevalence of metabolic syndrome (MS) and its components, i.e., central obesity, hypertension, prediabetes and dyslipidaemia. The goals of our study were two-fold. First, we characterised the relationships between eating duration, unprocessed and processed food consumption and metabolic health. During 4 weeks of observation, 213 adults used a smartphone application to record food and drink consumption, which was annotated for food processing levels following the NOVA classification. Low consumption of unprocessed food and low physical activity showed significant associations with multiple MS components. Second, in a pragmatic randomised controlled trial, we compared the metabolic benefits of 12 h time-restricted eating (TRE) to standard dietary advice (SDA) in 54 adults with an eating duration > 14 h and at least one MS component. After 6 months, those randomised to TRE lost 1.6% of initial body weight (SD 2.9, p = 0.01), compared to the absence of weight loss with SDA (−1.1%, SD 3.5, p = 0.19). There was no significant difference in weight loss between TRE and SDA (between-group difference −0.88%, 95% confidence interval −3.1 to 1.3, p = 0.43). Our results show the potential of smartphone records to predict metabolic health and highlight that further research is needed to improve individual responses to TRE such as a shorter eating window or its actual clock time.

scholarly journals Effect of Engaging Trainees by Assessing Peer Performance: A Randomised Controlled Trial Using Simulated Patient Scenarios

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Charlotte Loumann Krogh ◽  
Charlotte Ringsted ◽  
Charles B. Kromann ◽  
Maria Birkvad Rasmussen ◽  
Tobias Todsen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Global Rating ◽  
Training Performance ◽  
Significant Difference ◽  
Training Format ◽  
Peer Performance ◽  
And Performance ◽  
Randomised Controlled

Introduction. The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training.Methods. Eighty-four final year medical students participated in the study. The intervention involved trainees assessing peer performance during training. Outcome measures were in-training performance and performance, both of which were measured two weeks after the course. Trainees’ performances were videotaped and assessed by two expert raters using a checklist that included a global rating. Trainees’ satisfaction with the training was also evaluated.Results. The intervention group obtained a significantly higher overall in-training performance score than the control group: mean checklist score 20.87 (SD 2.51) versus 19.14 (SD 2.65)P=0.003and mean global rating 3.25 SD (0.99) versus 2.95 (SD 1.09)P=0.014. Postcourse performance did not show any significant difference between the two groups. Trainees who assessed peer performance were more satisfied with the training than those who did not: mean 6.36 (SD 1.00) versus 5.74 (SD 1.33)P=0.025.Conclusion. Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance, but not on the learning outcome measured two weeks later. Trainees had a positive attitude towards the training format.

scholarly journals Can topical epinephrine application to the papilla prevent pancreatitis after endoscopic retrograde cholangiopancreatography? Results from a double blind, multicentre, placebo controlled, randomised clinical trial

2021 ◽  
Vol 8 (1) ◽  
pp. e000562
Author(s):  
Adriana Fabiola Romano-Munive ◽  
J Jesus García-Correa ◽  
Luis F García-Contreras ◽  
José Ramírez-García ◽  
Luis Uscanga ◽  
...  
Keyword(s):  
Endoscopic Retrograde Cholangiopancreatography ◽  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Sterile Water ◽  
Endoscopic Retrograde ◽  
Double Blind ◽  
Registration Number ◽  
Baseline Characteristics ◽  
Randomised Controlled ◽  
Rectal Indomethacin

Background and study aimsPost-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a complication associated with important morbidity, occasional mortality and high costs. Preventive strategies are suboptimal as PEP continues to affect 4% to 9% of patients. Spraying epinephrine on the papilla may decrease oedema and prevent PEP. This study aimed to compare rectal indomethacin plus epinephrine (EI) versus rectal indomethacin plus sterile water (WI) for the prevention of PEP.Patients and methodsThis multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 mL of sterile water or a 1:10 000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure. The trial was stopped half way through after a new publication reported an increased incidence of PEP among patients receiving epinephrine.ResultsOf the 3602 patients deemed eligible, 3054 were excluded after screening. The remaining 548 patients were randomised to EI group (n=275) or WI group (n=273). The EI and WI groups had similar baseline characteristics. Patients in the EI group had a similar incidence of PEP to those in the WI group (3.6% (10/275) vs 5.12% (14/273), p=0.41). Pancreatic duct guidewire insertion was identified as a risk factor for PEP (OR 4.38, 95% CI (1.44 to 13.29), p=0.009).ConclusionSpraying epinephrine on the papilla was no more effective than rectal indomethacin alone for the prevention of PEP.Trial registration numberThis study was registered with ClinicalTrials.gov (NCT02959112).

scholarly journals The Effect of Glycomacropeptide versus Amino Acids on Phenylalanine and Tyrosine Variability over 24 Hours in Children with PKU: A Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 520 ◽  
Author(s):  
Anne Daly ◽  
Sharon Evans ◽  
Satnam Chahal ◽  
Saikat Santra ◽  
Alex Pinto ◽  
...  
Keyword(s):  
Amino Acids ◽  
Controlled Trial ◽  
Target Range ◽  
Blood Spots ◽  
Meal Plan ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Limiting Amino Acids ◽  
The Impact ◽  
Rate Limiting

Introduction: In phenylketonuria (PKU), evidence suggests that casein glycomacropeptide supplemented with rate-limiting amino acids (CGMP-AA) is associated with better protein utilisation and less blood phenylalanine (Phe) variability. Aim: To study the impact of CGMP-AA on blood Phe variability using 3 different dietary regimens in children with PKU. Methods: This was a 6-week randomised controlled cross-over study comparing CGMP-AA vs. Phe-free l-amino acids (l-AA) assessing blood Phe and tyrosine (Tyr) variability over 24 h in 19 children (7 boys) with PKU, with a median age of 10 years (6–16). Subjects were randomised to 3 dietary regimens: (1) R1, CGMP-AA and usual dietary Phe (CGMP + Phe); (2) R2, CGMP-AA − Phe content of CGMP-AA from usual diet (CGMP − Phe); and (3) R3, l-AA and usual dietary Phe. Each regimen was administered for 14 days. Over the last 48 h on days 13 and 14, blood spots were collected every 4 h at 08 h, 12 h, 16 h, 20 h, 24 h, and 04 h. Isocaloric intake and the same meal plan and protein substitute dosage at standardised times were maintained when blood spots were collected. Results: Eighteen children completed the study. Median Phe concentrations over 24 h for each group were (range) R1, 290 (30–580), R2, 220 (10–670), R3, 165 (10–640) μmol/L. R1 vs. R2 and R1 vs. R3 p < 0.0001; R2 vs. R3 p = 0.0009. There was a significant difference in median Phe at each time point between R1 vs. R2, p = 0.0027 and R1 vs. R3, p < 0.0001, but not between any time points for R2 vs. R3. Tyr was significantly higher in both R1 and R2 [70 (20–240 μmol/L] compared to R3 [60 (10–200) μmol/L]. In children < 12 years, blood Phe remained in the target range (120–360 μmol/L), over 24 h, for 75% of the time in R1, 72% in R2 and 64% in R3; for children aged ≥ 12 years, blood Phe was in target range (120–600 μmol/L) in R1 and R2 for 100% of the time, but 64% in R3. Conclusions: The residual Phe in CGMP-AA increased blood Phe concentration in children. CGMP-AA appears to give less blood Phe variability compared to l-AA, but this effect may be masked by the increased blood Phe concentrations associated with its Phe contribution. Reducing dietary Phe intake to compensate for CGMP-AA Phe content may help.

scholarly journals The prognosis of hepatoid adenocarcinoma of the stomach: a propensity score-based analysis

2020 ◽  
Author(s):  
Kai Zhou ◽  
Anqiang Wang ◽  
Sheng Ao ◽  
Jiahui Chen ◽  
Ke Ji ◽  
...  
Keyword(s):  
Propensity Score ◽  
Cox Regression ◽  
Radical Surgery ◽  
Survival Rates ◽  
Cancer Type ◽  
Radical Gastrectomy ◽  
Hepatoid Adenocarcinoma ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Propensity Matching

Abstract Background : To investigate whether there is a distinct difference in prognosis between hepatoid adenocarcinoma of the stomach ( HAS) and non-hepatoid adenocarcinoma of the stomach (non-HAS) and whether HAS can benefit from radical surgery. Methods : We retrospectively reviewed 722 patients with non-HAS and 75 patients with HAS who underwent radical gastrectomy between 3 November 2009 and 17 December 2018. Propensity score matching (PSM) analysis was used to eliminate the bias among the patients in our study. The relationships between gastric cancer type and overall survival (OS) were evaluated by the Kaplan-Meier method and Cox regression. Results : Our data demonstrate that there was no statistically significant difference in the OS between HAS and non-HAS {K-M, P=log rank (Mantel-Cox), (before PSM P=0.397); (1:1 PSM P=0.345); (1:2 PSM P=0.195)}. Moreover, there were no significant differences in the 1-, 2-, or 3-year survival rates between patients with non-HAS and patients with HAS (before propensity matching, after 1:1 propensity matching, and after 1:2 propensity matching). Conclusion : HAS was generally considered to be an aggressive gastric neoplasm, but its prognosis may not be as unsatisfactory as previously believed.

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