scholarly journals Assessment of an intervention to optimise antenatal management of women admitted with preterm labour and intact membranes using amniocentesis-based predictive risk models: study protocol for a randomised controlled trial (OPTIM-PTL Study)

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e054711
Author(s):  
Teresa Cobo ◽  
Victoria Aldecoa ◽  
Jose Luis Bartha ◽  
Fernando Bugatto ◽  
María Paz Carrillo-Badillo ◽  
...  
Keyword(s):  
High Risk ◽  
Hospital Stay ◽  
Preterm Labour ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Low Risk ◽  
Control Group ◽  
Type I ◽  
Microbial Invasion ◽  
Predictor Models

IntroductionThe majority of women admitted with threatened preterm labour (PTL) do not delivery prematurely. While those with microbial invasion of the amniotic cavity (MIAC) represent the highest risk group, this is a condition that is not routinely ruled out since it requires amniocentesis. Identification of low-risk or high-risk cases might allow individualisation of care, that is, reducing overtreatment with corticosteroids and shorten hospital stay in low-risk women, while allowing early antibiotic therapy in those with MIAC. Benefits versus risks of amniocentesis-based predictor models of spontaneous delivery within 7 days and/or MIAC have not been evaluated.Methods and analysisThis will be a Spanish randomised, multicentre clinical trial in singleton pregnancies (23.0–34.6 weeks) with PTL, conducted in 13 tertiary centres. The intervention arm will consist in the use of amniocentesis-based predictor models: if low risk, hospital discharge within 24 hours of results with no further medication will be recommended. If high risk, antibiotics will be added to standard management. The control group will be managed according to standard institutional protocols, without performing amniocentesis for this indication. The primary outcome will be total antenatal doses of corticosteroids, and secondary outcomes will be days of maternal stay and the occurrence of clinical chorioamnionitis. A cost analysis will be undertaken. To observe a reduction from 90% to 70% in corticosteroid doses, a reduction in 1 day of hospital stay (SD of 2) and a reduction from 24% to 12% of clinical chorioamnionitis, a total of 340 eligible patients randomised 1 to 1 to each study arm is required (power of 80%, with type I error α=0.05 and two-sided test, considering a dropout rate of 20%). Randomisation will be stratified by gestational age and centre.Ethics and disseminationPrior to receiving approval from the Ethics Committee (HCB/2020/1356) and the Spanish Agency of Medicines and Medical Devices (AEMPS) (identification number: 2020-005-202-26), the trial was registered in the European Union Drug Regulating Authorities Clinical Trials database (2020-005202-26). AEMPS approved the trial as a low-intervention trial. All participants will be required to provide written informed consent. Findings will be disseminated through workshops, peer-reviewed publications and national/international conferences.Protocol versionV.4 10 May 2021.Trial registration numbersNCT04831086 and Eudract number 2020-005202-26.

scholarly journals Rationale and design for Lowering-hyperUricaemia treatment on cardiovascular outcoMes In peritoNeal diAlysis patients: a prospective, multicentre, double-blind, randomised controlled trial (LUMINA)

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037842
Author(s):  
Wei Chen ◽  
Naya Huang ◽  
Haiping Mao ◽  
Xiao Yang ◽  
Qian Zhou ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Cardiovascular Outcomes ◽  
Control Group ◽  
Type I ◽  
Dialysis Patients ◽  
Double Blind ◽  
Randomised Controlled

IntroductionThe prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.Methods and analysesThis prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.Trial registration numberNCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.Protocol versionThe protocol version number and date are YLT-1604-V2.0 and 15 December 2016.

Five year follow up of a phase II study of cytotoxic immunotherapy combined with radiation in newly diagnosed prostate cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4635-4635 ◽  
Author(s):  
L. K. Aguilar ◽  
B. Teh ◽  
W. Mai ◽  
J. Caillouet ◽  
G. Ayala ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Controlled Trial ◽  
Pathologic Complete Response ◽  
Low Risk ◽  
Control Group ◽  
Newly Diagnosed ◽  
Kinase Gene ◽  
Cell Immunity

4635 Background: In the U.S. there are about 70,000 annual prostate cancer recurrences. The purpose of this study is to evaluate a product to decrease incidence of recurrence. This study is based on objective clinical responses in Phase I studies with AdV-tk (ProstAtak™, Advantagene, Inc) as monotherapy in recurrent disease and preclinical data demonstrating synergy between AdV-tk and radiation. AdV-tk is an adenoviral vector expressing the herpes thymidine kinase gene delivered to the prostate via TRUS-guided injection followed by 14 days of oral prodrug. The mechanisms of function involve direct tumor cytotoxicity, local elicitation of danger signals, recruitment and activation of antigen presenting cells and stimulation of systemic anti-tumor T-cell immunity. Method: AdV-tk was evaluated in combination with radiation in 66 newly diagnosed patients: 33 low risk (Arm A, PSA <10, Gleason <7, and T1c-T2a) and 33 intermediate-high risk (Arm B, PSA ≥10, Gleason ≥7, or T2b-T3). Arm A received two treatments with AdV-tk, immediately before and 14 days into radiation. Arm B received an additional treatment at initiation of androgen deprivation therapy. Results: Two surrogate and one definitive end-point were evaluated. Frequency of patients in Arm A with PSA nadir ≤0.2 ng/ml was 71% vs 56% in a control group of concurrent patients without AdV-tk. The two-year pathologic complete response (pCR) rate by sextant biopsy was 90% in Arm A and 94% in Arm B, compared to an expected range of 70–73%. Freedom from failure (FFF) after 60 month median follow up is 100% for Arm A and 90% for Arm B (95% for intermediate, 75% for high risk) vs best reported results of 79–90% for low risk and 48–79% for intermediate-high risk patients. The three failures in Arm B occurred within months after treatment leading to a Kaplan-Meier curve that plateaus at 90% beyond year 3. This is notably different than previous reports in which the curves continue to drop beyond year 5. Conclusion: These results suggest that AdV-tk combined with radiation therapy may significantly reduce the recurrence rate in patients with prostate cancer, particularly in patients with intermediate-high risk disease. A randomized controlled trial is warranted. [Table: see text]

Preventive effect of trimetazidine on contrast-induced nephropathy undergoing percutaneous coronary intervention in elderly moderate and high risk diabetics stratified by mehran score

Perfusion ◽  
2020 ◽  
pp. 026765912095205
Author(s):  
Xue Zhang ◽  
Peng Zhang ◽  
Shicheng Yang ◽  
Wenyuan Li ◽  
Xiuzhen Men ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
High Risk ◽  
Serum Creatinine ◽  
Coronary Intervention ◽  
Low Risk ◽  
Control Group ◽  
Preventive Effect ◽  
Contrast Induced Nephropathy ◽  
Risk Population ◽  
Percutaneous Coronary

Background: The aim of this research was to use the Mehran risk score to classify elderly diabetics with coronary heart disease to assess the preventive effect of trimetazidine on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) in different risk population. Methods: An uncompromised of 760 elderly diabetics that went through PCI were included in this research. The patients were first divided into three groups in the light of MRS: low-risk, moderate-risk, and high-risk group, then randomized into trimetazidine group and the control group respectively. The first endpoint was the amount of CIN, which is described as a rise in serum creatinine levels by ⩾44.2 μmol/L or ⩾25% ratio within 48 or 72 hours after medication. Second endpoint included differences in creatinine clearance rate (CrCl), blood urea nitrogen (BUN), serum creatinine (Scr), cystatin-C (Cys-C), and the incidence of major adverse events after administration. Results: In the three groups, the incidence of CIN in trimetazidine and control group was 5.0% versus 4.9%(χ2 = 0.005, p > 0.05), 8.0% versus 18.0% (χ2 = 7.685, p < 0.05), 10.4% versus 27.1% (χ2 = 4.376, p < 0.05), respectively. The multivariable logistic regression result demonstrated that trimetazidine intervention was a profitable element of CIN in moderate and high-risk groups (OR = 0.294, 95% CI 0.094-0.920, p = 0.035). Conclusion: Our study confirmed that trimetazidine can be considered for preventive treatment of CIN occurrence in elderly diabetics with moderate and high-risk population, while there is no obvious advantage compared with hydration therapy in low-risk patients.

Early Physical Therapy Effects on the High-Risk Infant: A Randomized Controlled Trial

PEDIATRICS ◽  
1986 ◽  
Vol 78 (2) ◽  
pp. 216-224
Author(s):  
Martha C. Piper ◽  
V. Ildiko Kunos ◽  
Diana M. Willis ◽  
Barbara L. Mazer ◽  
Maria Ramsay ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Therapy ◽  
High Risk ◽  
Motor Development ◽  
Controlled Trial ◽  
Physical Growth ◽  
Control Group ◽  
Randomized Controlled ◽  
Early Physical Therapy ◽  
The Impact

A prospective, randomized, controlled trial was conducted to assess the effects of early physical therapy on infants at risk for neurologic sequelae and to evaluate the impact of such early treatment on the prevention or minimization of future handicaps. A cohort of 134 infants who had received care in two Montreal inborn neonatal intensive care units was identified prospectively. Infants were stratified according to prognosis and birth weight and were randomly assigned to either an experimental or control group. Babies assigned to the experimental group received early physical therapy, whereas those allocated to the control group received conventional follow-up care. Outcome measures were administered by independent evaluators at 12 months and included measures of neurologic status, motor and overall development, and physical growth. No statistically significant differences on any of the measured outcomes at 12 months were found between the experimental and control groups. Infants weighing less than 750 g at birth, regardless of group assignment, consistently demonstrated significant delays in their growth and development when compared with their heavier peers. The early physical therapy program investigated in this study was not efficacious in altering the pattern of motor development in those high-risk infants participating in the trial.

INOVASIA Study: A Randomized Open Controlled Trial to Evaluate Pravastatin to Prevent Preeclampsia and its Effects on sFlt1/PLGF Levels

2021 ◽  
Author(s):  
Muhammad Ilham Aldika Akbar ◽  
Angelina Yosediputra ◽  
Raditya Eri Pratama ◽  
Nur Lailatul Fadhilah ◽  
Sulistyowati Sulistyowati ◽  
...  
Keyword(s):  
High Risk ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Perinatal Outcomes ◽  
Neonatal Morbidity ◽  
Clinical Risk Factor ◽  
Control Group ◽  
Significant Deterioration ◽  
Plgf Ratio

Objectives To evaluate the effect of pravastatin to prevent preeclampsia (PE) in pregnant women at a high risk of developing preeclampsia and the maternal and perinatal outcomes and the sFlt1/PLGF ratio. Study Design This is an open labelled RCT part of INOVASIA trial. Pregnant women at a high risk of developing PE were recruited and randomized into an intervention group (40) and a control group (40). The inclusion criteria consisted of pregnant women with positive clinical risk factor and abnormal uterine artery doppler examination at 10-20 weeks gestational age. The control group received low dose aspirin (80 mg/day) and calcium (1 g/day), while the intervention group received additional pravastatin (20 mg twice daily) starting from 14-20 weeks gestation until delivery. Research blood samples were collected before the first dose of pravastatin and before delivery. The main outcome was the rate of maternal preeclampsia, maternal-perinatal outcomes, and sFlt-1, PLGF, sFlt-1/PlGF ratio and sEng levels. Results The rate of preeclampsia was (non-significantly) lower in the pravastatin group compared with the control group (17.5% vs 35%). The pravastatin group also had a (non-significant) lower rate of severe preeclampsia, HELLP syndrome, acute kidney injury and severe hypertension. The rate of (iatrogenic) preterm delivery was significantly (p=0.048) lower in the pravastatin group (n=4) compared with the controls (n=12). Neonates in the pravastatin group had significantly higher birthweights (2931 + 537 vs 2625 + 872 g; p=0.006), lower Apgar scores < 7 (2.5 vs 27.5%, p=0.002), composite neonatal morbidity (0 vs 20%, p=0.005) and NICU admission rates (0 vs 15%, p=0.026). All biomarkers show a significant deterioration in the control group compared with non significant changes in the pravastatin group. Conclusions Pravastatin holds promise in the secondary prevention of preeclampsia and placenta-mediated adverse perinatal outcomes by improving the angiogenic imbalance.

scholarly journals Comparison of two caries prevention programs among Thai kindergarten: a randomized controlled trial

2020 ◽  
Author(s):  
Pagaporn Pantuwadee Pisarnturakit ◽  
Palinee Detsomboonrat
Keyword(s):  
High Risk ◽  
Controlled Trial ◽  
Low Risk ◽  
Kindergarten Children ◽  
Primary Molar ◽  
Permanent Molar ◽  
Carious Lesions ◽  
Caries Increment ◽  
Risk Approach ◽  
Clinical Trials Registry

Abstract Background: Intensified preventive regimen based on a ‘high-risk’ approach has been proposed instead the routine prevention that is generally given to the whole population. The effectiveness of these regimens may still be an issue. Therefore, the aim of this study was to compare two preventive programs carried out in a Public School for kindergarten children. Methods: The data from clinical examinations were used to assess the caries risk for 121 children. Children with at least 2 carious lesions were considered as high risk for dental caries development. These children were randomized into two groups. Half (High risk basic-HRB group) were provided the basic prevention regimen (oral-hygiene instruction and hands-on brushing practice for teachers and caregivers, daytime tooth brushing supervised by teachers at least once a week, newly erupted first permanent molar sealant, provision of toothbrush, fluoride-containing dentifrice, and a guidebook), which was also given to low-risk children (Low risk basic-LRB group). The other half (High risk intensive-HRI group) were additionally given an intensified preventive regimen (F-varnish application, primary molar sealant, and silver diamine fluoride (SDF) application on carious lesions). Clinical examinations were performed semiannually to determine the dmfs caries increment of the three groups. Results: The 89 children completed the 24-month examination were 3- to 5-year-old with 19, 35, and 35 children in the LRB, HRB, and HRI group, respectively. The new caries development at 24 months of the HRB group (75%) was higher than that of the HRI group (65.7%) and the LRB group (21.1%). One-way analysis of variance (ANOVA) indicated no significant differences of caries increment between the HRB and HRI groups at the end of our study ( p =0.709). Conclusions: The negligible difference in caries increment between the HRI and HRB groups implies that intensified prevention produced minimal additional benefit. Offering all children only basic prevention could have obtained virtually the same preventive effect with substantially less effort and lower cost. Trial registration: Thai Clinical Trials Registry (TCTR), TCTR20180124001. Registered 24 January 2018 - Retrospectively registered, https://www.clinicaltrials.in.th/TCTR20180124001.

Abstract TP168: Efficacy of a Pictogram to Promote Stroke Knowledge Among Illiterate Korean Elderly

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Cha-Nam Shin ◽  
Jeongha Sim ◽  
Dongchoon Ahn
Keyword(s):  
Older Adults ◽  
High Risk ◽  
Longitudinal Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Warning Signs ◽  
Repeated Measure ◽  
Control Group ◽  
Control Group Design ◽  
Stroke Knowledge

Background and Purpose: Extensive research supports the importance of knowledge in stroke prevention and reducing prehospital delay time. However, the level of stroke knowledge among Korean older adults remains low. In particular, older adults who are illiterate lack of stroke information despite being at high risk. The purpose of this study was to develop and examine the efficacy of a pictogram to enhance stroke knowledge in the high-risk and illiterate older adults. Methods: We conducted a pretest-posttest nonequivalent control group design study and compared differences in stroke knowledge before and after the intervention. A total of 117 older adults (82 in the intervention group and 35 in the control group) who were 60 years and older residing in community participated in the study. Participants in the intervention group received a pictogram-based education, while participants in the control group received a powerpoint-based education. Stroke knowledge was measured by structured survey questionnaires. Descriptive statistics for sample characteristics, repeated measure ANOVA for the efficacy, and independent t-test for satisfaction comparison between groups were used. Results: The intervention group showed a higher increase in stroke knowledge (F=16.45), awareness of risk factors (F=15.71), stroke warning signs and symptoms (F=17.29), and action at stroke (F=19.36) compared to the control group at p <.001. Also, the intervention group reported that they would recommend the education program to others (t=2.64, p<.05) and the program was applicable to real situation (t=4.47, p <.001), which were scored higher than the control group. Conclusions: The data revealed that a pictogram-based education is more effective than a powerpoint-based education among illiterate older adults. Replicated studies with this pictogram in a larger randomized controlled trial is warranted, which may give greater validity to our findings. Future longitudinal research is recommended to examine retention of stroke knowledge over the long term.

scholarly journals Polysaccharide hemostatic powder to prevent bleeding after endoscopic submucosal dissection in high risk patients: A randomized controlled trial

Endoscopy ◽  
2020 ◽  
Author(s):  
Da Hyun Jung ◽  
Chan Hyuk Park ◽  
Hee Seok Moon ◽  
Jun Chul Park
Keyword(s):  
High Risk ◽  
Endoscopic Submucosal Dissection ◽  
Controlled Trial ◽  
Gastric Neoplasms ◽  
Control Group ◽  
High Risk Patients ◽  
Randomized Controlled ◽  
Submucosal Dissection ◽  
Risk Patients ◽  
Hemostatic Powder

Background and aims: Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Several methods to prevent post-ESD bleeding (PEB) have been introduced; however, they have not been widely used because of technical difficulties. We aimed to investigate whether polysaccharide hemostatic powder (PHP), which is very easy to apply, can prevent early PEB, especially in patients with high risk of PEB. Methods: This was a prospective, multicenter, randomized, open-label, controlled trial. Patients with a high risk for PEB were enrolled. Patients with gastric neoplasms in whom the resected specimen size was expected to be >40 mm and those who were regularly taking antithrombotic agents were defined as high-risk patients. Patients were randomly assigned to the PHP or control group. Results: Between May 2017 and September 2018, 143 patients were enrolled (PHP group: 73, control group: 70). The total PEB rate was 6.3% (PHP group: 5% vs. control group: 7.1%, P=0.742). There was no bleeding within 7 days after ESD in the PHP group. Continued antithrombotic use was an independent risk factor of PEB. In subgroup analysis excluding patients who continued to take antithrombotics (n=129) during ESD, the rate of PEB was tended to be lower in the PHP group than in the control group (0% vs. 6.3%, P=0.058). Conclusion: PHP did not demonstrate a significant effect on the prevention of PEB in this study. Further larger-scale, randomized controlled trials are needed to confirm this.(ClinicalTrials.gov 03169569)

scholarly journals The value of routine mid-trimester ultrasound in low-risk pregnancies at primary care level

2008 ◽  
Vol 13 (4) ◽  
pp. 41-49 ◽  
Author(s):  
B Van Dyk ◽  
JA Motto ◽  
EJ Buchmann
Keyword(s):  
Antenatal Care ◽  
Low Birthweight ◽  
Controlled Trial ◽  
Open Cluster ◽  
Mode Of Delivery ◽  
Low Risk ◽  
Control Group ◽  
Ultrasound Scan ◽  
Second Trimester ◽  
Ultrasound Scanning

This study investigated the effect of routine second-trimester ultrasound scanning on obstetric management and pregnancy outcomes. This was an open cluster, randomised, controlled trial. Clusters of women with low-risk pregnancies presenting in the second trimester were randomised to receive an ultrasound scan followed by usual antenatal care, or to an unscanned control group undergoing conventional antenatal care only. Out of the 962 women randomised, follow-up was successful for 804 (83.6%), with 416 allocated to the ultrasound scan group and 388 controls. There were no significant differences between the ultrasound scan group and the control group in terms of prenatal hospitalisation, mode of delivery, miscarriage, perinatal mortality rate and low birthweight rate. Ultrasound dating was associated with a lower rate of induction of labour for post-term pregnancy (1.4% vs. 3.6%; P=0.049). However, ultrasound scanning in low-risk pregnancies was not associated with improvements in pregnancy outcome. Opsomming Hierdie studie het die effek van roetine mid-trimester ultraklankskandering op swangerskapsorg en –uitkomste ondersoek. Dit was ’n oop tros, lukrake, beheerde proef. Groepe vroue met laerisikoswanger- skap in die midtrimester is lukraak toegewys vir ’n ultraklank-skandering, gevolg deur voorgeskrewe voorgeboor-tesorg, of vir ’n kontrolegroep wat voorgeboortesorg volgens nasionaal voorgeskrewe protokol sonder skandering ontvang het. Van die 962 vroue wat aan die steekproef deelgeneem het kon data vir 804 (83.6%) suksesvol opgevolg word, met 416 in die ultraklankgroep en 388 in die kontrolegroep. Geen beduidende verskille is tussen die twee groepe gevind ten opsigte van voorgeboorte-hospitalisasie, geboortemetode, miskraamstatistiek, perinatale komplikasies of laegeboortegewig nie. Ultraklankdatering van swangerskappe is met minder kraaminduksie (1.4% teen 3.6%; P=0.049) vir natrimesterswangerskap geassosieer. Roetine ultraklankskandering in laerisikoswangerskap het egter geen verbetering in swangerskapsuitkomste te weeg gebring nie.

scholarly journals Salivary Cytokine Biomarker Concentrations in Relation to Obesity and Periodontitis

2019 ◽  
Vol 8 (12) ◽  
pp. 2152 ◽  
Author(s):  
Sanna Syrjäläinen ◽  
Ulvi Kahraman Gursoy ◽  
Mervi Gursoy ◽  
Pirkko Pussinen ◽  
Milla Pietiäinen ◽  
...  
Keyword(s):  
High Risk ◽  
Cumulative Risk ◽  
Normal Weight ◽  
Low Risk ◽  
Control Group ◽  
Low Grade ◽  
Periodontal Status ◽  
Tnf Α ◽  
Medium Risk ◽  
And Control

Systemic low-grade inflammation is associated with obesity. Our aim was to examine the association between obesity and salivary biomarkers of periodontitis. Salivary interleukin (IL)-1-receptor antagonist (IL-1Ra), IL-6, IL-8, IL-10, and tumor necrosis factor (TNF)-α concentrations were measured from 287 non-diabetic obese (body mass index (BMI) of >35 kg/m2) individuals and 293 normal-weight (BMI of 18.5–25 kg/m2) controls. Periodontal status was defined according to a diagnostic cumulative risk score (CRS) to calculate the risk of having periodontitis (CRS I, low risk; CRS II, medium risk; CRS III, high risk). In the whole population, and especially in smokers, higher IL-8 and lower IL-10 concentrations were detected in the obese group compared to the control group, while in non-smoking participants, the obese and control groups did not differ. IL-1Ra and IL-8 concentrations were higher in those with medium or high risk (CRS II and CRS III, p < 0.001) of periodontitis, whereas IL-10 and TNF-α concentrations were lower when compared to those with low risk (CRS I). In multivariate models adjusted for periodontal status, obesity did not associate with any salivary cytokine concentration. In conclusion, salivary cytokine biomarkers are not independently associated with obesity and concentrations are dependent on periodontal status.

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