Relationship Between Obesity and Periodontal Disease

NCT02508415 | Completed DMC

• 1 other identifier: UMalaya
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is an epidemic with increasing prevalence in the Asia Pacific region. The first Malaysian national estimate in 1996 of obesity was 5.8%. A systematic review reported a marked increase in obesity in 2003, 2004 and 2006 with 12.2%, 12.3% and 14.0% respectively. Periodontal disease is a chronic inflammatory disease which results in gingival inflammation, irreversible attachment loss, alveolar bone destruction and eventually tooth loss. Worldwide, the prevalence of periodontitis in the adult population is about 10-15%. Periodontal disease, through inflammation and destruction of the periodontium produces clinical signs and symptoms, some of which may have a considerable impact on quality of life (QoL). A positive association between obesity and periodontal disease was repeatedly demonstrated worldwide. Obese individuals have elevated levels of circulating TNF- α and IL-6 compared to normal weight individuals. These cytokines decrease after weight loss. Adipokines produced by adipose tissue could be one of the mechanisms mediating the association between obesity and periodontal disease. This suggests that obesity may have the potential to modify the host's immunity and inflammatory system. This project will extend the existing information on the association between obesity and periodontal disease including QoL aspect to a Malaysia population. It will also improve knowledge on the cellular and molecular mechanisms that underpin obesity-periodontal disease relationship. By extension, this study also will cast light on the effects of periodontal interventions for the subgroup population.

Conditions

Obese; Periodontal Disease

Keywords

obesity; periodontal disease; intervention

Outcome Measures

Primary Outcomes (1)

• changes in clinical attachment levels (CAL) (mean CAL in mm, as a measure for periodontal parameters) following non surgical periodontal therapy

  baseline to 12 weeks

Secondary Outcomes (2)

• Oral health related quality of life (OHRQoL)

  baseline to 12 weeks

• salivary resistin (measured in ng/ml)

  baseline to 12 weeks

Study Arms (2)

Non Surgical Periodontal Therapy

EXPERIMENTAL

Will receive oral hygiene education, scaling and root planing. OHE includes brushing and flossing techniques, chlorhexidine mouth rinse twice a day

Other: Non Surgical Periodontal Therapy

No Non Surgical Periodontal Therapy

NO INTERVENTION

No treatment received

Interventions

Non Surgical Periodontal Therapy OTHER

OHE, scaling root planing, mouth wash

Non Surgical Periodontal Therapy

Eligibility Criteria

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

You may qualify if:

• Obese i.e. BMI ≥ 30 kg/m2 (WHO 1997)
• Age should be ≥ 30 years old
• Patients should have at least 12 teeth present

You may not qualify if:

• Non Malaysian subjects
• Patients who have received periodontal treatment within the past 4 months
• Patients who have been on antibiotics within the past 4 months
• Patients who require prophylactic antibiotic coverage
• Patients who have been on systemic or topical steroidal anti-inflammatory drugs for the past 4 months
• Patients who are pregnant and lactating mothers
• Patients who are mentally handicapped that may interfere with oral hygiene procedures

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry

Lembah Pantai, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (12)

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  PMID: 10968727 BACKGROUND

• Asia Pacific Cohort Studies Collaboration. The burden of overweight and obesity in the Asia-Pacific region. Obes Rev. 2007 May;8(3):191-6. doi: 10.1111/j.1467-789X.2006.00292.x.

  PMID: 17444961 BACKGROUND

• Khambalia AZ, Seen LS. Trends in overweight and obese adults in Malaysia (1996-2009): a systematic review. Obes Rev. 2010 Jun;11(6):403-12. doi: 10.1111/j.1467-789X.2010.00728.x. Epub 2010 Mar 11.

  PMID: 20233309 BACKGROUND

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  PMID: 16600411 BACKGROUND

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  PMID: 21348914 BACKGROUND

• Chaffee BW, Weston SJ. Association between chronic periodontal disease and obesity: a systematic review and meta-analysis. J Periodontol. 2010 Dec;81(12):1708-24. doi: 10.1902/jop.2010.100321. Epub 2010 Aug 19.

  PMID: 20722533 BACKGROUND

• Page RC. The role of inflammatory mediators in the pathogenesis of periodontal disease. J Periodontal Res. 1991 May;26(3 Pt 2):230-42. doi: 10.1111/j.1600-0765.1991.tb01649.x.

  PMID: 1679130 BACKGROUND

• Yudkin JS, Stehouwer CD, Emeis JJ, Coppack SW. C-reactive protein in healthy subjects: associations with obesity, insulin resistance, and endothelial dysfunction: a potential role for cytokines originating from adipose tissue? Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):972-8. doi: 10.1161/01.atv.19.4.972.

  PMID: 10195925 BACKGROUND

• Steppan CM, Bailey ST, Bhat S, Brown EJ, Banerjee RR, Wright CM, Patel HR, Ahima RS, Lazar MA. The hormone resistin links obesity to diabetes. Nature. 2001 Jan 18;409(6818):307-12. doi: 10.1038/35053000.

  PMID: 11201732 BACKGROUND

• Hiroshima Y, Bando M, Inagaki Y, Mihara C, Kataoka M, Murata H, Shinohara Y, Nagata T, Kido J. Resistin in gingival crevicular fluid and induction of resistin release by Porphyromonas gingivalis lipopolysaccharide in human neutrophils. J Periodontal Res. 2012 Oct;47(5):554-62. doi: 10.1111/j.1600-0765.2011.01466.x. Epub 2012 Feb 6.

  PMID: 22309231 BACKGROUND

• Devanoorkar A, Dwarakanath CD, Gundanavar G, Kathariya R, Patil SR. Evaluation of serum resistin levels in periodontal health and disease and effects of non surgical periodontal therapy on its levels. Dis Markers. 2012;32(5):289-94. doi: 10.1155/2012/153418.

  PMID: 22848926 BACKGROUND

• Basher SS, Saub R, Vaithilingam RD, Safii SH, Daher AM, Al-Bayaty FH, Baharuddin NA. Impact of non-surgical periodontal therapy on OHRQoL in an obese population, a randomised control trial. Health Qual Life Outcomes. 2017 Nov 21;15(1):225. doi: 10.1186/s12955-017-0793-7.

  PMID: 29157276 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

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: July 27, 2015
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

MY (1)