Obese Clinical Trial
— EONSPTOfficial title:
The Effects of Obesity on Non Surgical Periodontal Therapy
Verified date | November 2015 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | Malaysia: Institutional Review Board |
Study type | Interventional |
The investigators' earlier study reported a high prevalence of chronic periodontitis among obese Malaysian adult population. Non-surgical periodontal therapy (NSPT) has been shown to effectively reduce microbial load and contributes to reduction in periodontal parameters and inflammatory burden up to 6 months post-therapy. This study will cast light on the effects of obesity on chronic periodontitis (CP) patients following NSPT. The objectives of the study were to quantify and to compare the periodontal pathogens, serum and salivary interleukins in obese and non obese with CP following NSPT.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Those who are obese - Those whose age are 30 years and above - Those who have at least 12 teeth present Exclusion Criteria: - Those who have received periodontal treatment within the last 4 months - Those who have been on antibiotics within the past 4 months - Those who require prophylactic antibiotic coverage, on systemic or topical steroidal anti-inflammatory drugs for the past 4 months, - Those who are pregnant or intend to be pregnant - Those lactating mothers, mentally handicapped |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Malaya |
Al-Zahrani MS, Bissada NF, Borawskit EA. Obesity and periodontal disease in young, middle-aged, and older adults. J Periodontol. 2003 May;74(5):610-5. — View Citation
Albandar JM, Brunelle JA, Kingman A. Destructive periodontal disease in adults 30 years of age and older in the United States, 1988-1994. J Periodontol. 1999 Jan;70(1):13-29. Erratum in: J Periodontol 1999 Mar;70(3):351. — View Citation
Albandar JM, Tinoco EM. Global epidemiology of periodontal diseases in children and young persons. Periodontol 2000. 2002;29:153-76. Review. — View Citation
Brennan DS, Spencer AJ, Roberts-Thomson KF. Quality of life and disability weights associated with periodontal disease. J Dent Res. 2007 Aug;86(8):713-7. — View Citation
Brown LJ, Löe H. Prevalence, extent, severity and progression of periodontal disease. Periodontol 2000. 1993 Jun;2:57-71. Review. — View Citation
D'Aiuto F, Parkar M, Andreou G, Suvan J, Brett PM, Ready D, Tonetti MS. Periodontitis and systemic inflammation: control of the local infection is associated with a reduction in serum inflammatory markers. J Dent Res. 2004 Feb;83(2):156-60. — View Citation
Després JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. Review. — View Citation
Fentoglu Ö, Köroglu BK, Hiçyilmaz H, Sert T, Özdem M, Sütçü R, Tamer MN, Orhan H, Ay ZY, Öztürk Tonguç M, Kirzioglu FY. Pro-inflammatory cytokine levels in association between periodontal disease and hyperlipidaemia. J Clin Periodontol. 2011 Jan;38(1):8-16. doi: 10.1111/j.1600-051X.2010.01644.x. Epub 2010 Nov 10. — View Citation
Hugoson A, Norderyd O, Slotte C, Thorstensson H. Distribution of periodontal disease in a Swedish adult population 1973, 1983 and 1993. J Clin Periodontol. 1998 Jul;25(7):542-8. — View Citation
Khader YS, Bawadi HA, Haroun TF, Alomari M, Tayyem RF. The association between periodontal disease and obesity among adults in Jordan. J Clin Periodontol. 2009 Jan;36(1):18-24. doi: 10.1111/j.1600-051X.2008.01345.x. Epub 2008 Nov 19. — View Citation
Khan S, Saub R, Vaithilingam RD, Safii SH, Vethakkan SR, Baharuddin NA. Prevalence of chronic periodontitis in an obese population: a preliminary study. BMC Oral Health. 2015 Sep 29;15:114. doi: 10.1186/s12903-015-0098-3. — View Citation
Khosravi R, Ka K, Huang T, Khalili S, Nguyen BH, Nicolau B, Tran SD. Tumor necrosis factor- a and interleukin-6: potential interorgan inflammatory mediators contributing to destructive periodontal disease in obesity or metabolic syndrome. Mediators Inflamm. 2013;2013:728987. doi: 10.1155/2013/728987. Epub 2013 Aug 28. Review. — View Citation
Kurukulasuriya LR, Stas S, Lastra G, Manrique C, Sowers JR. Hypertension in obesity. Med Clin North Am. 2011 Sep;95(5):903-17. doi: 10.1016/j.mcna.2011.06.004. Review. — View Citation
Marotta T, Russo BF, Ferrara LA. Triglyceride-to-HDL-cholesterol ratio and metabolic syndrome as contributors to cardiovascular risk in overweight patients. Obesity (Silver Spring). 2010 Aug;18(8):1608-13. doi: 10.1038/oby.2009.446. Epub 2009 Dec 17. — View Citation
Matsushita Y, Nakagawa T, Yamamoto S, Kato T, Ouchi T, Kikuchi N, Takahashi Y, Yokoyama T, Mizoue T, Noda M. Adiponectin and visceral fat associate with cardiovascular risk factors. Obesity (Silver Spring). 2014 Jan;22(1):287-91. doi: 10.1002/oby.20425. Epub 2013 Jun 11. — View Citation
Mohamud WN, Musa KI, Khir AS, Ismail AA, Ismail IS, Kadir KA, Kamaruddin NA, Yaacob NA, Mustafa N, Ali O, Isa SH, Bebakar WM. Prevalence of overweight and obesity among adult Malaysians: an update. Asia Pac J Clin Nutr. 2011;20(1):35-41. — View Citation
Noh MK, Jung M, Kim SH, Lee SR, Park KH, Kim DH, Kim HH, Park YG. Assessment of IL-6, IL-8 and TNF-a levels in the gingival tissue of patients with periodontitis. Exp Ther Med. 2013 Sep;6(3):847-851. Epub 2013 Jul 15. — View Citation
Park SH, Park JH, Song PS, Kim DK, Kim KH, Seol SH, Kim HK, Jang HJ, Lee JG, Park HY, Park J, Shin KJ, Kim Di, Moon YS. Sarcopenic obesity as an independent risk factor of hypertension. J Am Soc Hypertens. 2013 Nov-Dec;7(6):420-5. doi: 10.1016/j.jash.2013.06.002. Epub 2013 Jul 30. — View Citation
Perlstein MI, Bissada NF. Influence of obesity and hypertension on the severity of periodontitis in rats. Oral Surg Oral Med Oral Pathol. 1977 May;43(5):707-19. — View Citation
Petersen PE, Bourgeois D, Ogawa H, Estupinan-Day S, Ndiaye C. The global burden of oral diseases and risks to oral health. Bull World Health Organ. 2005 Sep;83(9):661-9. Epub 2005 Sep 30. — View Citation
Petersen PE. The World Oral Health Report 2003: continuous improvement of oral health in the 21st century--the approach of the WHO Global Oral Health Programme. Community Dent Oral Epidemiol. 2003 Dec;31 Suppl 1:3-23. — View Citation
Rasmussen F, Hancox RJ. Mechanisms of obesity in asthma. Curr Opin Allergy Clin Immunol. 2014 Feb;14(1):35-43. doi: 10.1097/ACI.0000000000000024. Review. — View Citation
Ryan ME. Nonsurgical approaches for the treatment of periodontal diseases. Dent Clin North Am. 2005 Jul;49(3):611-36, vii. Review. — View Citation
Saxlin T, Ylöstalo P, Suominen-Taipale L, Männistö S, Knuuttila M. Association between periodontal infection and obesity: results of the Health 2000 Survey. J Clin Periodontol. 2011 Mar;38(3):236-42. doi: 10.1111/j.1600-051X.2010.01677.x. Epub 2010 Dec 27. — View Citation
Trayhurn P, Wood IS. Adipokines: inflammation and the pleiotropic role of white adipose tissue. Br J Nutr. 2004 Sep;92(3):347-55. Review. — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in clinical attachment level (CAL) (mean in mm, as a measure of periodontal parameter) in obese and non obese, with chronic periodontitis following NSPT | 12 weeks | No | |
Secondary | Changes in microbial profile (mean count of Porphyromonas gingivalis, Tannerella forsythia, Prevotella intermedia and Actinobacillus actinomycetemcomitans quality and quantity) in obese and non obese, with chronic periodontitis before and after NSPT | 12 weeks | No | |
Secondary | Changes in serum interleukins levels (mean value in ng/mL, of TNF-a, IL-1, IL-6 and resistin) in obese and non obese, with chronic periodontitis before and after NSPT | 12 weeks | No | |
Secondary | Changes in salivary interleukins levels (mean value in ng/mL, of TNF-a, IL-1, IL-6 and resistin) in obese and non obese, with chronic periodontitis before and after NSPT | 12 weeks | No |
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