Metabolic Syndrome Clinical Trial
Official title:
Association Between Periodontitis and Adverse Pregnancy Outcomes in Metabolic Syndrome Patients- Interventional Study
Aim The Aim of the current study is to establish the association between periodontitis and
adverse pregnancy outcomes in metabolic syndrome (Mets) patients and to evaluate the effect
of intervention.
Objectives
1. To evaluate the changes in periodontal status of pregnant women with metabolic syndrome
after non surgical periodontal therapy (NSPT)
2. To evaluate the inflammatory marker levels in serum of pregnant women with metabolic
syndrome after non surgical periodontal therapy
3. To evaluate the effect of NSPT on adverse pregnancy outcomes of women with metabolic
syndrome
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 1, 2018 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 34 Years |
Eligibility |
Inclusion criteria: - Patients with Mets - Primi gravida - Singleton pregnancy < 20 weeks gestation - 18-34 years of age - More than 20 teeth in the mouth Exclusion criteria: - Previous history of abortion - Assisted reproduction procedures like fertility medication or in vitro fertilization - Positive history of HIV - Positive history of genitourinary infections in previous 6 months - Any medical contraindication to periodontal probing - Undergone periodontal treatment or using chlorhexidine or other mouth rinses in the previous 6 months - Rampant decay - Taken systemic antibiotic or anti-in?ammatory drugs in the last 6 months before the start of the study, or reported use of phenytoin, cyclosporine, calcium antagonists and/or hormone replacement therapy - Alcoholics - Smokers and ex-smokers - History of kidney, liver or lung disease - History of any other chronic or acute infections during the previous 6 months as assessed on clinical examination or routine lab testing |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Riyadh Colleges of Dentistry and Pharmacy | Riyadh | |
Saudi Arabia | Riyadh Colleges of Dentistry and Pharmacy | Riyadh |
Lead Sponsor | Collaborator |
---|---|
Riyadh Colleges of Dentistry and Pharmacy |
Saudi Arabia,
Al Qahtani, Joseph B, Deepthi A, Vijayakumari B, Prevalence of chronic periodontitis and its risk determinants among female patients in the Aseer Region of KSA, Journal of Taibah University Medical Sciences .Volume 12, Issue 3, June 2017, Pages 241-248
Al-Nozha M, Al-Khadra A, Arafah MR, Al-Maatouq MA, Khalil MZ, Khan NB, Al-Mazrou YY, Al-Marzouki K, Al-Harthi SS, Abdullah M, Al-Shahid MS, Al-Mobeireek A, Nouh MS. Metabolic syndrome in Saudi Arabia. Saudi Med J. 2005 Dec;26(12):1918-25. — View Citation
Al-Qurashi FO, Yousef AA, Awary BH. Epidemiological aspects of prematurity in the Eastern region of Saudi Arabia. Saudi Med J. 2016 Apr;37(4):414-9. doi: 10.15537/smj.2016.4.14309. — View Citation
Athyros VG, Ganotakis ES, Elisaf M, Mikhailidis DP. The prevalence of the metabolic syndrome using the National Cholesterol Educational Program and International Diabetes Federation definitions. Curr Med Res Opin. 2005 Aug;21(8):1157-9. — View Citation
Benguigui C, Bongard V, Ruidavets JB, Chamontin B, Sixou M, Ferrières J, Amar J. Metabolic syndrome, insulin resistance, and periodontitis: a cross-sectional study in a middle-aged French population. J Clin Periodontol. 2010 Jul;37(7):601-8. doi: 10.1111/j.1600-051X.2010.01571.x. Epub 2010 May 13. — View Citation
Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4. — View Citation
Dos Prazeres Tavares H, Dos Santos DC, Abbade JF, Negrato CA, de Campos PA, Calderon IM, Rudge MV. Prevalence of metabolic syndrome in non-diabetic, pregnant Angolan women according to four diagnostic criteria and its effects on adverse perinatal outcomes. Diabetol Metab Syndr. 2016 Mar 22;8:27. doi: 10.1186/s13098-016-0139-3. eCollection 2016. — View Citation
Fiorini T, Susin C, da Rocha JM, Weidlich P, Vianna P, Moreira CH, Bogo Chies JA, Rösing CK, Oppermann RV. Effect of nonsurgical periodontal therapy on serum and gingival crevicular fluid cytokine levels during pregnancy and postpartum. J Periodontal Res. 2013 Feb;48(1):126-33. doi: 10.1111/j.1600-0765.2012.01513.x. Epub 2012 Jul 27. — View Citation
Green SB. How Many Subjects Does It Take To Do A Regression Analysis. Multivariate Behav Res. 1991 Jul 1;26(3):499-510. doi: 10.1207/s15327906mbr2603_7. — View Citation
Grundy SM. Metabolic syndrome pandemic. Arterioscler Thromb Vasc Biol. 2008 Apr;28(4):629-36. doi: 10.1161/ATVBAHA.107.151092. Epub 2008 Jan 3. Review. — View Citation
Ide M, Papapanou PN. Epidemiology of association between maternal periodontal disease and adverse pregnancy outcomes--systematic review. J Clin Periodontol. 2013 Apr;40 Suppl 14:S181-94. doi: 10.1111/jcpe.12063. Review. — View Citation
Iheozor-Ejiofor Z, Middleton P, Esposito M, Glenny AM. Treating periodontal disease for preventing adverse birth outcomes in pregnant women. Cochrane Database Syst Rev. 2017 Jun 12;6:CD005297. doi: 10.1002/14651858.CD005297.pub3. Review. — View Citation
International Diabetes Federation. Information on the IDF consensus worldwide definition of the metabolic syndrome. http://www.idf.org/webdata/docs/IDF_Meta_def_final.pdf Accessed 2014 Apr 10.
Knight ET, Liu J, Seymour GJ, Faggion CM Jr, Cullinan MP. Risk factors that may modify the innate and adaptive immune responses in periodontal diseases. Periodontol 2000. 2016 Jun;71(1):22-51. doi: 10.1111/prd.12110. Review. — View Citation
LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. — View Citation
Offenbacher S, Beck JD, Jared HL, Mauriello SM, Mendoza LC, Couper DJ, Stewart DD, Murtha AP, Cochran DL, Dudley DJ, Reddy MS, Geurs NC, Hauth JC; Maternal Oral Therapy to Reduce Obstetric Risk (MOTOR) Investigators. Effects of periodontal therapy on rate of preterm delivery: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):551-9. doi: 10.1097/AOG.0b013e3181b1341f. — View Citation
Page RC, Eke PI. Case definitions for use in population-based surveillance of periodontitis. J Periodontol. 2007 Jul;78(7 Suppl):1387-99. Review. — View Citation
Penova-Veselinovic B, Keelan JA, Wang CA, Newnham JP, Pennell CE. Changes in inflammatory mediators in gingival crevicular fluid following periodontal disease treatment in pregnancy: relationship to adverse pregnancy outcome. J Reprod Immunol. 2015 Nov;112:1-10. doi: 10.1016/j.jri.2015.05.002. Epub 2015 May 27. — View Citation
Sanz M, D'Aiuto F, Deanfield J, Fernandez-Avilés F. European workshop in periodontal health and cardiovascular disease-scientific evidence on the association between periodontal and cardiovascular diseases: A review of the literature. Eur Heart J Suppl 2010;12 Suppl B:B3-12
SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Periodontal parameters- Change in Gingival Index | Gingival index (GI). All teeth except third molars will be evaluated for gingival in?ammation using a modi?cation of the Loe and Silness , 1963 GI. The GI uses the following scores: 0 = normal gingiva; 1 = mild in?ammation; 2 = moderate in?ammation; and 3 = severe in?ammation. Gingival index will be evaluated at four sites per tooth | • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery | |
Primary | Periodontal parameters- Change in Plaque Index | Plaque index (PI). Prebrushing plaque scores for the buccal surface of each tooth will be assigned using a zero to three scale (Silness and Loe, 1964 ) PI, with ''0''indicating an absence of plaque on the clinical crown and a ''3'' indicating the presence of soft deposits covering more than two-thirds of the crown. Plaque index will be evaluated at four sites per tooth |
• At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery | |
Primary | Periodontal parameters-Change in Bleeding on probing | Bleeding on probing will be evaluated at six sites per tooth | • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery | |
Primary | Periodontal parameters- Change in Probing depth (PD) | A manual periodontal probe UNC-15, Hu-Friedy, Chicago, IL ,will be used to record on all teeth present in the mouth. Probing depth will be calculated from gingival margin to base of pocket. Probing depth will be evaluated at six sites per tooth |
• At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery | |
Primary | Periodontal parameters- Change in Clinical attachment level (CAL) | A manual periodontal probe UNC-15, Hu-Friedy, Chicago, IL ,will be used to record on all teeth present in the mouth. CAL will be calculated using the clinically detectable cemento-enamel junction (CEJ) as reference and it will be measured from CEJ to base of pocket. Clinical attachment level will be evaluated at six sites per tooth |
• At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery | |
Secondary | Serum bio markers -Change in Interleukin-6(IL-6) | A 5-ml sample of peripheral venous blood will be collected by vein puncture. The blood samples will be centrifuged at 3000 g for 5 min and the serum will be separated. The serum samples will be frozen in plastic vials at -20ºC until further analyzing. Commercially available ELISA assays will be used to measure concentrations of IL-6 in blood samples, according to the manufacturer's recommendations. | • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery | |
Secondary | Serum bio markers -Change in Prostaglandin-E2 ( PG-E2) | A 5-ml sample of peripheral venous blood will be collected by vein puncture. The blood samples will be centrifuged at 3000 g for 5 min and the serum will be separated. The serum samples will be frozen in plastic vials at -20ºC until further analyzing. Commercially available ELISA assays will be used to measure concentrations of PGE2 in blood samples, according to the manufacturer's recommendations. | • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery | |
Secondary | Pregnancy Outcomes -Preterm birth neonate | Preterm birth < 37 weeks neonate taken from patients record | • Within 1-2 days of delivery | |
Secondary | Pregnancy Outcomes -Low birth weight neonate | Low birth weight < 2500 gms neonate as taken from patients record | • Within 1-2 days of delivery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04635202 -
Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome
|
N/A | |
Completed |
NCT05343858 -
Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome
|
N/A | |
Completed |
NCT04053686 -
An Intervention to Reduce Prolonged Sitting in Police Staff
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Recruiting |
NCT05040958 -
Carotid Atherosclerotic Plaque Load and Neck Circumference
|
||
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Completed |
NCT03289897 -
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
|
N/A | |
Recruiting |
NCT05956886 -
Sleep Chatbot Intervention for Emerging Black/African American Adults
|
N/A | |
Completed |
NCT06057896 -
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
|
||
Active, not recruiting |
NCT03613740 -
Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
|
Phase 2 | |
Completed |
NCT04498455 -
Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency
|
Phase 4 | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Completed |
NCT03697382 -
Effect of Daily Steps on Fat Metabolism
|
N/A | |
Completed |
NCT03241121 -
Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome
|
N/A | |
Completed |
NCT04509206 -
Virtual Teaching Kitchen
|
N/A | |
Completed |
NCT05124847 -
TREating Pediatric Obesity
|
N/A |