The Effects of Obesity on Non Surgical Periodontal Therapy

NCT02618486 | Completed DMC

• 1 other identifier: 101269-1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obese; Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Changes in serum interleukins levels (mean value in ng/mL, of TNF-α, IL-1, IL-6 and resistin) in obese and non obese, with chronic periodontitis before and after NSPT

  12 weeks

• Changes in salivary interleukins levels (mean value in ng/mL, of TNF-α, IL-1, IL-6 and resistin) in obese and non obese, with chronic periodontitis before and after NSPT

  12 weeks

Study Arms (2)

Obese with CP

EXPERIMENTAL

Procedure/Surgery Non surgical periodontal therapy Received OHE, scaling and root planing. OHE includes brushing and flossing techniques, chlorhexidine rinse thrice a day

Procedure: Non surgical periodontal therapy

Non obese with CP

ACTIVE COMPARATOR

Procedure/Surgery Non surgical periodontal therapy Received OHE, scaling and root planing. OHE includes brushing and flossing techniques, chlorhexidine rinse thrice a day

Procedure: Non surgical periodontal therapy

Interventions

Non surgical periodontal therapy PROCEDURE

NSPT includes oral hygiene education, scaling root planing and mouth wash

Also known as: NSPT

Non obese with CP; Obese with CP

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who are obese
• Those whose age are 30 years and above
• Those who have at least 12 teeth present

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Related Publications (26)

• 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.

  PMID: 26419358 BACKGROUND

• Albandar JM, Tinoco EM. Global epidemiology of periodontal diseases in children and young persons. Periodontol 2000. 2002;29:153-76. doi: 10.1034/j.1600-0757.2002.290108.x. No abstract available.

  PMID: 12102707 BACKGROUND

• 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. doi: 10.1902/jop.1999.70.1.13.

  PMID: 10052767 BACKGROUND

• 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. doi: 10.1111/j.1600-051x.1998.tb02485.x.

  PMID: 9696253 BACKGROUND

• Brown LJ, Loe H. Prevalence, extent, severity and progression of periodontal disease. Periodontol 2000. 1993 Jun;2:57-71. doi: 10.1111/j.1600-0757.1993.tb00220.x. No abstract available.

  PMID: 9673181 BACKGROUND

• 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.

  PMID: 16211157 BACKGROUND

• 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. doi: 10.1177/154405910708600805.

  PMID: 17652197 BACKGROUND

• 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. doi: 10.1046/j..2003.com122.x.

  PMID: 15015736 BACKGROUND

• 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.

  PMID: 21393108 BACKGROUND

• 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.

  PMID: 21855699 BACKGROUND

• 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.

  PMID: 23910010 BACKGROUND

• 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.

  PMID: 20019684 BACKGROUND

• 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.

  PMID: 23519992 BACKGROUND

• 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.

  PMID: 24300417 BACKGROUND

• Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.

  PMID: 17167477 BACKGROUND

• 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. doi: 10.1016/0030-4220(77)90055-x.

  PMID: 266151 BACKGROUND

• 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. doi: 10.1902/jop.2003.74.5.610.

  PMID: 12816292 BACKGROUND

• 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.

  PMID: 19046327 BACKGROUND

• Trayhurn P, Wood IS. Adipokines: inflammation and the pleiotropic role of white adipose tissue. Br J Nutr. 2004 Sep;92(3):347-55. doi: 10.1079/bjn20041213.

  PMID: 15469638 BACKGROUND

• Khosravi R, Ka K, Huang T, Khalili S, Nguyen BH, Nicolau B, Tran SD. Tumor necrosis factor- alpha 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.

  PMID: 24068858 BACKGROUND

• Fentoglu O, Koroglu BK, Hicyilmaz H, Sert T, Ozdem M, Sutcu R, Tamer MN, Orhan H, Ay ZY, Ozturk Tonguc 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.

  PMID: 21062339 BACKGROUND

• Noh MK, Jung M, Kim SH, Lee SR, Park KH, Kim DH, Kim HH, Park YG. Assessment of IL-6, IL-8 and TNF-alpha levels in the gingival tissue of patients with periodontitis. Exp Ther Med. 2013 Sep;6(3):847-851. doi: 10.3892/etm.2013.1222. Epub 2013 Jul 15.

  PMID: 24137277 BACKGROUND

• Saxlin T, Ylostalo P, Suominen-Taipale L, Mannisto 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.

  PMID: 21198765 BACKGROUND

• 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. doi: 10.1177/154405910408300214.

  PMID: 14742655 BACKGROUND

• Ryan ME. Nonsurgical approaches for the treatment of periodontal diseases. Dent Clin North Am. 2005 Jul;49(3):611-36, vii. doi: 10.1016/j.cden.2005.03.010.

  PMID: 15978244 BACKGROUND

• Md Tahir K, Ab Malek AH, Vaithilingam RD, Saub R, Safii SH, Rahman MT, Abdul Razak F, Alabsi AM, Baharuddin NA. Impact of non-surgical periodontal therapy on serum Resistin and periodontal pathogen in periodontitis patients with obesity. BMC Oral Health. 2020 Feb 14;20(1):52. doi: 10.1186/s12903-020-1039-3.

  PMID: 32059714 DERIVED

MeSH Terms

Conditions

Obesity; Periodontal Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nor_Adinar Baharuddin, DClinDent

  Faculty of Dentistry University of Malaya Kuala Lumpur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: December 1, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 1, 2015

Record last verified: 2015-11