scholarly journals Nutritional Support and Clinical Outcome of Severe and Critical Patients With COVID-19 Pneumonia

2020 ◽  
Vol 7 ◽  
Author(s):  
Xiangfeng Yue ◽  
Min Li ◽  
Yu Wang ◽  
Jing Zhang ◽  
Xinyi Wang ◽  
...  
Keyword(s):  
Protein Intake ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Antiviral Treatment ◽  
Small Sample ◽  
Nutrition Support ◽  
Calorie Intake ◽  
Viral Shedding ◽  
Significant Difference ◽  
Critical Patients

Background: In 2020, a novel coronavirus has spread throughout the world. More than four hundred thousand people have died of SARS-CoV-2 pneumonia, most of which were severe and critical patients. No effective antiviral treatment has been verified thus far. Nutrition support has become one of the important treatments for severe and critical patients.Methods: In this retrospective study, 26 severe patients and 22 critical patients with laboratory confirmed COVID-19 were enrolled. We recorded the diet and nutritional treatments in severe and critical patients. Baseline characteristics and clinical outcomes of severe and critical patients were also collected.Results: Average calorie intake of severe patients (19.3 kcal/kg/d) was higher than critical patients (15.3 kcal/kg/d) (P = 0.04). Protein intake was similar in the two groups (0.65 and 0.62 g/kg per day, respectively; P = 0.29). There was no significant difference in the median duration of viral shedding between the severe and critical patients (P = 0.354).Conclusions: A permissive underfeeding strategy that restricts non-protein calories but preserves protein intake is feasible for critical patients with SARS-CoV-2 pneumonia. Viral shedding duration of critical patients was the same as severe patients who received standard feeding. Nevertheless, evidence of the conclusion is not sufficient because of small sample size. To show the real clinical benefit of permissive low-calorie and adequate protein intake in critical SARS-CoV-2 pneumonia patients, a large and pragmatic randomized controlled trial is needed.

scholarly journals DrillCutTM vs. VersaCutTM prostate tissue morcellation devices after holmium laser enucleation: A prospective, randomized controlled trial

2018 ◽  
Vol 13 (8) ◽  
Author(s):  
Ahmed Ibrahim ◽  
Mostafa M. Elhilali ◽  
Mohammed A. Elkoushy ◽  
Sero Andonian ◽  
Serge Carrier
Keyword(s):  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Holmium Laser ◽  
Complication Rates ◽  
Symptomatic Benign Prostatic Hyperplasia ◽  
Significant Difference ◽  
Ethical Approval ◽  
Laser Enucleation ◽  
Holmium Laser Enucleation

Introduction: We aimed to compare efficacy, safety, and cost of disposables of the DrillCutTM morcellator with the VersaCutTM morcellator after holmium laser enucleation of the prostate (HoLEP).Methods: After obtaining ethical approval, consecutive patients undergoing HoLEP for symptomatic benign prostatic hyperplasia were randomized to have their enucleated prostates morcellated by either Karl Storz® DrillCutTM or Lumenis® VersaCutTM morcellators. All procedures were performed by two experienced urologists. Patients’ demographics and perioperative data were recorded. Both morcellators were compared for their safety, efficacy, and cost-effectiveness.Results: Eighty-two patients were included in the study (41 per each arm). Both groups were comparable in terms of age, preoperative prostate size (114 vs. 112 mL; p>0.05), enucleation time (95.3 vs. 91.7 minutes; p>0.05), and morcellation time (22.6 vs. 17.3 minutes; p>0.05). The DrillCutTM was associated with significantly lower morcellation rate when compared with the VersaCutTM(3.6 vs. 4.9 g/min; p= 0.03). In terms of safety, there was no significant difference between both morcellators in complication rates (2.4% vs. 7.3 %; p=0.1). However, there was one case of bladder perforation requiring exploration with the VersaCutTM. The DrillCutTM was associated with significantly higher cost of disposables when compared with the VersaCutTM ($247.5 vs. $160.9; p<0.01).Conclusions: Despite the small sample size, the DrillCutTM was associated with lower morcellation rate when compared with the VersaCutTM. However, this difference may not be clinically significant. Although both morcellators were comparable in their safety, the DrillCutTM was associated with higher cost of disposables when compared with the VersaCutTM.

Comprehensive Geriatric Care to Improve Mobility after Hip Fracture: An RCT

Gerontology ◽  
2020 ◽  
Vol 66 (6) ◽  
pp. 542-548
Author(s):  
Wendy L. Cook ◽  
Penelope M.A. Brasher ◽  
Pierre Guy ◽  
Stirling Bryan ◽  
Meghan G. Donaldson ◽  
...  
Keyword(s):  
Hip Fracture ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Geriatric Care ◽  
Small Sample ◽  
Community Dwelling ◽  
Post Discharge ◽  
Mobility Performance ◽  
Discharge Care ◽  
Comprehensive Geriatric Care

<b><i>Background:</i></b> Comprehensive geriatric care (CGC) for older adults during hospitalization for hip fracture can improve mobility, but it is unclear whether CGC delivered after a return to community living improves mobility compared with usual post-discharge care. <b><i>Objective:</i></b> To determine if an outpatient clinic-based CGC regime in the first year after hip fracture improved mobility performance at 12 months. <b><i>Methods:</i></b> A two-arm, 1:1 parallel group, pragmatic, single-blind, single-center, randomized controlled trial at 3 hospitals in Vancouver, BC, Canada. Participants were community-dwelling adults, aged ≥65 years, with a hip fracture in the previous 3–12 months, who had no dementia and walked ≥10 m before the fracture occurred. Target enrollment was 130 participants. Clinic-based CGC was delivered by a geriatrician, physiotherapist, and occupational therapist. Primary outcome was the Short Physical Performance Battery (SPPB; 0–12) at 12 months. <b><i>Results:</i></b> We randomized 53/313 eligible participants with a mean (SD) age of 79.7 (7.9) years to intervention (<i>n</i> = 26) and usual care (UC, <i>n</i> = 27), and 49/53 (92%) completed the study. Mean 12-month (SD) SPPB scores in the intervention and UC groups were 9.08 (3.03) and 8.24 (2.44). The between-group difference was 0.9 (95% CI –0.3 to 2.0, <i>p</i> = 0.13). Adverse events were similar in the 2 groups. <b><i>Conclusion:</i></b> The small sample size of less than half our recruitment target precludes definitive conclusions about the effect of our intervention. However, our results are consistent with similar studies on this population and intervention.

scholarly journals NI-19 Use of 11C-methionine PET for decision of discontinuation of adjuvant chemotherapy with temozolomide

2020 ◽  
Vol 2 (Supplement_3) ◽  
pp. ii14-ii14
Author(s):  
Takaaki Beppu ◽  
Yuichi Sato ◽  
Toshiaki Sasaki ◽  
Kazunori Terasaki ◽  
Kuniaki Ogasawara
Keyword(s):  
Adjuvant Chemotherapy ◽  
Small Sample Size ◽  
Standardized Uptake Value ◽  
Progression Free Survival ◽  
Residual Tumor ◽  
Small Sample ◽  
Tumor Type ◽  
Diffuse Astrocytoma ◽  
Significant Difference ◽  
Met Pet

Abstract Background: The aim was to clarify whether positron emission tomography with 11C-methyl-L-methionine (met-PET) is useful to decide on discontinuation of TMZ-adjuvant therapy in patients with residual diffuse astrocytic tumor. Methods: Subjects were 44 patients with residual tumor comprising 17 with IDH1-mutant diffuse astrocytoma (DA), 13 with IDH1-mutant anaplastic astrocytoma (AA), and 14 with IDH1-wild glioblastoma (GB). All patients received TMZ-adjuvant chemotherapy (median, 12 courses), and whether to discontinue or continue TMZ-adjuvant chemotherapy was decided on the basis of the tumor-to-normal ratio in standardized uptake value from met-PET (T/N); patients with T/N &lt; 1.6 immediately discontinued TMZ, and patients with T/N &gt; 1.6 were either to continued or discontinued TMZ. Progression-free survival (PFS) was compared between patients with T/N &gt; 1.6 and T/N &lt; 1.6 in each tumor type. Median observation period was 434 days after met-PET scanning. Results: The number of patient who underwent recurrence was 10 in DA, 7 in AA, and 11 in GB. All patients showing T/N &gt; 1.6 underwent tumor recurrence. PFS was significantly longer in patients with T/N &lt; 1.6 than T/N &gt; 1.6 in DA and AA (p &lt; 0.01 in both types), but was no significant difference between 2 groups in GB (p = 0.06). Sixteen of 17 patients (94%) in DA and AA showed recurrence from residual tumor, whereas 4 of 11 patients (36%) in GB showed recurrent tumor at remote regions which were different from residual tumor. Conclusions: The present study suggested that met-PET is beneficial to decide to discontinue adjuvant chemotherapy with TMZ in patients with residual tumors of DA and AA, but not useful for patients with GB. Reasons for unsuccessful results in GB might have been small sample size, failure of establishing the cut off value in T/N, recurrences at remote regions where not be assessed by met-PET.

scholarly journals 1611. Evaluating Clinical Outcomes and Efficacy of Daptomycin in Combination with a Beta-Lactam for the Treatment of Vancomycin-Resistant Enterococcus (VRE) Bacteremia

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S799-S800
Author(s):  
Nerea Irusta ◽  
Ana Vega ◽  
Yoichiro Natori ◽  
Lilian M Abbo ◽  
Lilian M Abbo ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Primary Outcome ◽  
Small Sample Size ◽  
Univariate Analysis ◽  
Small Sample ◽  
Significant Difference ◽  
Vancomycin Resistant ◽  
Secondary Outcomes ◽  
Related Mortality

Abstract Background In-vitro studies have shown synergistic bactericidal activity with daptomycin (DAP) plus β-lactam antimicrobials against vancomycin resistant enterococci (VRE). There is a paucity of data regarding clinical outcomes with this combination in VRE bloodstream infections (BSI). The purpose of this study was to assess the efficacy of DAP plus a β-lactam with in-vitro activity vs. other therapies for treatment of VRE BSI. Methods IRB-approved, single-center, retrospective study of patients with VRE BSI from 01/2018-09/2019. Patients were excluded if &lt; 18 years old, pregnant, or incarcerated. The primary outcome was time-to-microbiological clearance. Secondary outcomes included infection-related mortality, 30-day all-cause mortality, and incidence of recurrent BSI within 30 days of index culture. Targeted DAP doses were ≥ 8mg/kg and based on MIC. Factors associated with significance for outcomes, via univariate analysis, were evaluated with multivariable logistic regression (MLR), removed in a backward-step approach. Results A total of 85 patients were included, 23 of which received DAP plus a β-lactam. The comparator arm included linezolid or DAP monotherapy. Patients with combination therapy had significantly higher Charlson Comorbidity Index (CCI) (p=0.013) and numerically higher Pitt Bacteremia scores (PBS) (p=0.087) (Table 1). There was no difference seen in the primary outcome (Table 2). Secondary outcomes are provided in Table 2. The presence of polymicrobial infection and higher PBS were significantly associated with infection-related mortality (p=0.008 and p=0.005, respectively) by MLR. A Mann Whitney U test indicated that presence of infection-related mortality was greater for patients with higher MICS (U=20.5, p=0.06). The presence of an underlying source may be related to recurrence of BSI (p=0.075). Table 1: Patient Characteristics Table 2. Primary and Secondary Outcomes Conclusion We did not find a significant difference in time-to-microbiological clearance, although patients treated with DAP and a β-lactam had higher CCI and PBS. These results are limited by retrospective design, small sample size, and potential selection bias. Prospective randomized studies are needed to further validate these findings. Disclosures All Authors: No reported disclosures

scholarly journals Fecal viral DNA shedding following clinical panleukopenia virus infection in shelter kittens: a prospective, observational study

2021 ◽  
pp. 1098612X2110230
Author(s):  
Kyrsten J Janke ◽  
Linda S Jacobson ◽  
Jolene A Giacinti ◽  
J Scott Weese
Keyword(s):  
Small Sample Size ◽  
Point Of Care ◽  
Small Sample ◽  
Enteric Pathogens ◽  
Test Results ◽  
Viral Dna ◽  
Virus Shedding ◽  
Feline Panleukopenia Virus ◽  
Viral Shedding ◽  
Point Of Care Test

Objectives The aims of this study were to determine the magnitude and duration of fecal viral DNA shedding after diagnosis of feline panleukopenia (FP) in a group of shelter cats using quantitative real-time PCR (qPCR); to assess the utility of a negative point-of-care test or the resolution of diarrhea and systemic signs as proxy measures for qPCR positivity; and to investigate patterns of additional enteric pathogens in relation to feline panleukopenia viral shedding duration. Methods Feline panleukopenia virus (FPV) infection in clinically affected shelter cats was confirmed by a commercial qPCR test. Observations were made on days 0, 3, 7, 14 and 21 post-diagnosis. Fecal flotation, FPV qPCR and the canine parvovirus IDEXX SNAP Parvo ELISA (SNAP) test were performed on fecal samples. Results Forty cats and kittens with confirmed panleukopenia were initially enrolled. Sixteen kittens were sampled until day 14, and 12 were followed to day 21. Median DNA viral copy numbers fell below the diagnostic cut-off by day 7, with 13/16, 6/16, 1/16 and 0/12 testing PCR-positive on days 3, 7, 14 and 21, respectively. The SNAP test was positive in 12/16 kittens on day 0 and only 3/16 on day 3. SNAP test results, diarrhea and systemic signs were inconsistent in relation to qPCR positivity post-diagnosis. Additional enteric pathogens were common. The presence of additional pathogen types was suggestive of a longer PCR shedding duration, but this was not tested statistically owing to the small sample size. Conclusions and relevance These findings suggest that cats should be isolated for at least 14 days after a diagnosis of FP, but that release from isolation after this point is reasonable, in association with a multifaceted infection control strategy. The study findings did not support using SNAP test results, diarrhea or systemic signs as proxy measures for virus shedding.

scholarly journals Perioperative Outcomes Following Kidney-Pancreas Transplantation in Alberta, Canada: Research Letter

2021 ◽  
Vol 8 ◽  
pp. 205435812110293
Author(s):  
Danielle E. Fox ◽  
Robert R. Quinn ◽  
Paul E. Ronksley ◽  
Tyrone G. Harrison ◽  
Hude Quan ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Postoperative Care ◽  
Pancreas Transplantation ◽  
Type I Diabetes ◽  
Small Sample Size ◽  
Small Sample ◽  
Perioperative Outcomes ◽  
Type I ◽  
Patient Safety Indicators ◽  
Significant Difference

Background: Simultaneous kidney-pancreas transplantation (SPK) has benefits for patients with kidney failure and type I diabetes mellitus, but is associated with greater perioperative risk compared with kidney-alone transplantation. Postoperative care settings for SPK recipients vary across Canada and may have implications for patient outcomes and hospital resource use. Objective: To compare outcomes following SPK transplantation between patients receiving postoperative care in the intensive care unit (ICU) compared with the ward. Design: Retrospective cohort study using administrative health data. Setting: In Alberta, the 2 transplant centers (Calgary and Edmonton) have different protocols for routine postoperative care of SPK recipients. In Edmonton, SPK recipients are routinely transferred to the ICU, whereas in Calgary, SPK recipients are transferred to the ward. Patients: 129 adult SPK recipients (2002-2019). Measurements: Data from the Canadian Institute for Health Information Discharge Abstract Database (CIHI-DAD) were used to identify SPK recipients (procedure codes) and the outcomes of inpatient mortality, length of initial hospital stay (LOS), and the occurrence of 16 different patient safety indicators (PSIs). Methods: We followed SPK recipients from the admission date of their transplant hospitalization until the first of hospital discharge or death. Unadjusted quantile regression was used to determine differences in LOS, and age- and sex-adjusted marginal probabilities were used to determine differences in PSIs between centers. Results: There were no perioperative deaths and no major differences in the demographic characteristics between the centers. The majority of the SPK transplants were performed in Edmonton (n = 82, 64%). All SPK recipients in Edmonton were admitted to the ICU postoperatively, compared with only 11% in Calgary. There was no statistically significant difference in the LOS or probability of a PSI between the 2 centers (LOS for Edmonton vs Calgary:16 vs 13 days, P = .12; PSIs for Edmonton vs Calgary: 60%, 95% confidence interval [CI] = 0.50-0.71 vs 44%, 95% CI = 0.29-0.59, P = .08). Limitations: This study was conducted using administrative data and is limited by variable availability. The small sample size limited precision of estimated differences between type of postoperative care. Conclusions: Following SPK transplantation, we found no difference in inpatient outcomes for recipients who received routine postoperative ICU care compared with ward care. Further research using larger data sets and interventional study designs is needed to better understand the implications of postoperative care settings on patient outcomes and health care resource utilization.

scholarly journals DIAGNOSIS OF ENDOCRINE DISEASE: The diagnostic performance of adrenal biopsy: a systematic review and meta-analysis

2016 ◽  
Vol 175 (2) ◽  
pp. R65-R80 ◽  
Author(s):  
Irina Bancos ◽  
Shrikant Tamhane ◽  
Muhammad Shah ◽  
Danae A Delivanis ◽  
Fares Alahdab ◽  
...  
Keyword(s):  
Systematic Review ◽  
Diagnostic Performance ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Small Sample ◽  
Cochrane Central Register ◽  
Moderate Risk ◽  
Adrenal Biopsy ◽  
Adrenocortical Carcinomas

ObjectiveTo perform a systematic review of published literature on adrenal biopsy and to assess its performance in diagnosing adrenal malignancy.MethodsMedline In-Process and Other Non-Indexed Citations, MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trial were searched from inception to February 2016. Reviewers extracted data and assessed methodological quality in duplicate.ResultsWe included 32 observational studies reporting on 2174 patients (39.4% women, mean age 59.8 years) undergoing 2190 adrenal mass biopsy procedures. Pathology was described in 1621/2190 adrenal lesions (689 metastases, 68 adrenocortical carcinomas, 64 other malignancies, 464 adenomas, 226 other benign, 36 pheochromocytomas, and 74 others). The pooled non-diagnostic rate (30 studies, 2013 adrenal biopsies) was 8.7% (95%CI: 6–11%). The pooled complication rate (25 studies, 1339 biopsies) was 2.5% (95%CI: 1.5–3.4%). Studies were at a moderate risk for bias. Most limitations related to patient selection, assessment of outcome, and adequacy of follow-up. Only eight studies (240 patients) could be included in the diagnostic performance analysis with a sensitivity and specificity of 87 and 100% for malignancy, 70 and 98% for adrenocortical carcinoma, and 87 and 96% for metastasis respectively.ConclusionsEvidence based on small sample size and moderate risk of bias suggests that adrenal biopsy appears to be most useful in the diagnosis of adrenal metastasis in patients with a history of extra-adrenal malignancy. Adrenal biopsy should only be performed if the expected findings are likely to alter the management of the individual patient and after biochemical exclusion of catecholamine-producing tumors to help prevent potentially life-threatening complications.

Abstract 3725: Simvastatin but Not Pravastatin Affects Sleep: Findings from the UCSD Statin Study

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Beatrice A Golomb ◽  
Edwin K Kwon ◽  
Michael H Criqui ◽  
Joel E Dimsdale
Keyword(s):  
Sleep Quality ◽  
Rating Scale ◽  
Sleep Problems ◽  
Small Sample Size ◽  
Case Reports ◽  
Controlled Trial ◽  
Small Sample ◽  
T Test ◽  
Secondary Outcome ◽  
Regression Analyses

Background : Case reports have suggested possible effects of lipophilic statins on sleep in some subjects. Most randomized studies evaluating the effect of statins on sleep have had small sample size and short duration (≤ 6 weeks). Whether statins affect sleep on average, favorably or adversely, has been unclear. Goal : To assess the effects of lipophilic and hydrophilic statins on sleep. Subjects : 1016 adult men and women without diabetes or heart disease, with LDL-cholesterol 115–190mg/dL. Design : Randomized double blind placebo-controlled trial of simvastatin 20mg, pravastatin 40mg or placebo for 6 months. Sleep was a prespecified secondary outcome. It was assessed by both an adaptation of the Leeds sleep scale (a visual analog scale of sleep quality); and a rating scale of sleep problems. Both items were measured at baseline and on-treatment. Analysis : Baseline comparability of randomization groups including sleep measures was affirmed. T-test of mean on-treatment sleep scores across randomization groups was performed. This complemented regression analyses, adjusted for baseline values of the respective sleep assessment. Results : Groups were comparable at baseline on variables including both sleep measures. Simvastatin use was associated with significantly worse sleep quality, and significantly greater reported sleep problems than either pravastatin or placebo, by t-test and regression analyses. Pravastatin did not differ significantly from placebo on any sleep outcome. Conclusion : Findings were compatible with the hypothesis that statins may impair sleep in some subjects, and that this impairment may arise selectively with lipophilic statins. Table 1. Effects of Statins on Sleep: Regression Analysis

Three-year results of phase I retinal gene therapy trial for CNGA3-mutated achromatopsia: results of a non randomised controlled trial

2021 ◽  
pp. bjophthalmol-2021-319067
Author(s):  
Felix Friedrich Reichel ◽  
Stylianos Michalakis ◽  
Barbara Wilhelm ◽  
Ditta Zobor ◽  
Regine Muehlfriedel ◽  
...  
Keyword(s):  
Gene Therapy ◽  
Primary Endpoint ◽  
Statistical Power ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Small Sample ◽  
Functional Improvement ◽  
Limiting Factor ◽  
Serious Adverse Events

AimsTo determine long-term safety and efficacy outcomes of a subretinal gene therapy for CNGA3-associated achromatopsia. We present data from an open-label, nonrandomised controlled trial (NCT02610582).MethodsDetails of the study design have been previously described. Briefly, nine patients were treated in three escalating dose groups with subretinal AAV8.CNGA3 gene therapy between November 2015 and October 2016. After the first year, patients were seen on a yearly basis. Safety assessment constituted the primary endpoint. On a secondary level, multiple functional tests were carried out to determine efficacy of the therapy.ResultsNo adverse or serious adverse events deemed related to the study drug occurred after year 1. Safety of the therapy, as the primary endpoint of this trial, can, therefore, be confirmed. The functional benefits that were noted in the treated eye at year 1 were persistent throughout the following visits at years 2 and 3. While functional improvement in the treated eye reached statistical significance for some secondary endpoints, for most endpoints, this was not the case when the treated eye was compared with the untreated fellow eye.ConclusionThe results demonstrate a very good safety profile of the therapy even at the highest dose administered. The small sample size limits the statistical power of efficacy analyses. However, trial results inform on the most promising design and endpoints for future clinical trials. Such trials have to determine whether treatment of younger patients results in greater functional gains by avoiding amblyopia as a potential limiting factor.

A comparative assessment of orthodontic treatment outcomes using the quantitative light-induced fluorescence (QLF) method between direct bonding and indirect bonding techniques in adolescents: a single-centre, single-blind randomized controlled trial

2019 ◽  
Vol 42 (4) ◽  
pp. 441-453
Author(s):  
Aykan Onur Atilla ◽  
Taner Ozturk ◽  
Mustafa Murat Eruz ◽  
Ahmet Yagci
Keyword(s):  
Orthodontic Treatment ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
White Spot Lesion ◽  
Indirect Bonding ◽  
Signed Rank ◽  
Group 12 ◽  
Registration Number ◽  
Bonding Technique

Summary Introduction The aim of this two-arm parallel trial was to evaluate enamel demineralization in fixed orthodontic treatment using an indirect bonding technique in comparison to a direct bonding technique by the quantitative light-induced fluorescence (QLF) method. Design, settings and participants Fifty-six patients who needed fixed orthodontic treatment were randomly separated into either the direct bonding group or the indirect bonding group. The presence and extent of lesions on the buccal surfaces of all teeth, except the molar teeth, were assessed. The percentage of fluorescence loss (ΔF and ΔFmax), the degree of demineralization (ΔQ) and lesion area (WS area) were determined using the system’s software. The data were analysed with the Wilcoxon signed-rank and Mann–Whitney U-tests (P &lt; 0.05). Interventions Treatment with a direct bonding or an indirect bonding technique. Results This study was completed with 25 patients in the indirect bonding group (12 females, 13 males; mean age: 15.42 ± 1.71 years) and 26 patients in the direct bonding group (12 females, 14 males; mean age: 14.73 ± 1.65 years). In the indirect bonding technique, a few teeth (especially mandibular left canine: 50.45 ± 93.48; 95% confidence interval: −12.35 and 113.26) were found to develop significant white spot lesion (WSL) formation (P &lt; 0.05). However, the number of teeth with demineralization was higher in the direct bonding group (P &lt; 0.05). Conclusion The bonding procedures used in the indirect bonding technique contribute to reducing the degree of WSL formation. Further, the use of flowable composite adhesives in this bonding process is more effective at reducing the appearance of WSLs than in cases where conventional composite adhesives are used. Limitations The limitation of our trial may be the small sample size and the short follow-up time for the patients. Harms No harms were detected during the study. Protocol The protocol was not published before trial commencement. Registration This trial was registered post hoc at ‘Clinical Trials’ (http://www.clinicaltrials.gov), registration number (ID): NCT03738839.

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