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Relationship Between Obesity and Periodontal Disease (ROPD)

Primary Purpose

Obese, Periodontal Disease

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Non Surgical Periodontal Therapy
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese focused on measuring obesity, periodontal disease, intervention

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Non Surgical Periodontal Therapy

No Non Surgical Periodontal Therapy

Arm Description

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

No treatment received

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Oral health related quality of life (OHRQoL)
salivary resistin (measured in ng/ml)

Full Information

First Posted
April 2, 2015
Last Updated
July 24, 2015
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT02508415
Brief Title
Relationship Between Obesity and Periodontal Disease
Acronym
ROPD
Official Title
Relationship Between Obesity and Periodontal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Obesity is an epidemic with increasing prevalence in most countries in the Asia Pacific region. It is characterized by abnormal or excessive lipid deposition as a result of chronic disproportion between energy intake and energy outflow. The first Malaysian national estimate in 1996 of obesity was 5.8%. A systematic review reported a marked increase in obesity in 1996, 2003, 2004 and 2006 with 5.5%, 12.2%, 12.3% and 14.0%. Obesity is highest among adults of 40-59 years old, is greater risk in women compared to men and is highest among Indians followed by Malays, Chinese and Aboriginals. Periodontitis and obesity are both chronic health problems, and an association between the two conditions exists. A positive association was repeatedly demonstrated between obesity and periodontal disease in multiple studies around the world. Periodontal disease is a chronic oral infection, in which destruction of tooth supporting structures, periodontal ligament and alveolar bone occurs, leading ultimately to tooth loss. Worldwide, the prevalence of periodontitis in the adult population is about 10-15%. In Malaysia, the National Oral Health study reported 90.2% of the adults presented with some forms of periodontal conditions. About 5.5% of these subjects had deep pockets of 6 mm or more. Periodontal disease, through inflammation and destruction of the periodontium produces a wide range of clinical signs and symptoms, some of which may have a considerable impact on quality of life (QoL). A study conducted using a community sample found a significant association between periodontal disease and quality of life (QoL). They also found that self-reported symptoms of periodontal diseases such as swollen gums, sore gums and receding gums has an apparent impact on the quality of life of the person. With the mechanism of obesity, it is expected that the obese patients may have experienced more severe periodontal diseases and hence they may experience more impact on the quality of life. However, the evidence is still lacking. Cytokines play a role in the pathogenesis of periodontitis. They play an active role in wound repair and in transient inflammation. They also activate defence mechanisms in which they may give rise to considerable tissue damage in severe inflammation. Adipose tissue cells namely adipocytes, preadipocytes and macrophages secrete protein signals collectively known as adipokines or adipocytokines. Adipokines are involved in inflammation and the acute-phase response. Production of adipokines increased in obesity, and raised circulating levels of several acute-phase proteins and inflammatory cytokines. This has led to the concept that obese is a state of chronic low-grade systemic inflammation causally link to insulin resistance and metabolic syndrome. Salivary components comprising of several inflammatory and immune mediators have been identified which are involved in periodontal destruction. Among all the adipokines, resistin which is an adipocyte-derived cytokine is raised in obese mice. In humans, it is suggested that resistin is largely expressed from neutrophils, macrophages, and monocytes other than adipocytes. Resistin is identified as a proinflammatory adipokine that potentially links obesity to diabetes. It is also believed that human resistin stimulates the production and secretion of other proinflammatory molecules like tumor necrosis factor (TNF)-α and interleukin (IL)-12. Studies have shown high levels of resistin in subjects having chronic periodontitis and this may affect systemic health. In a study by Devanoorkar et al., stated that the decrease in the resistin levels was not statistically significant following non-surgical periodontal therapy. The reason for the interest in GCF/serum levels of resistin in periodontitis lies in the fact that epidemiological research indicates that periodontitis interplays between obesity and diabetes mellitus. It is possible that raised levels of resistin in periodontitis can explain at least in part the link between periodontitis and other chronic inflammatory diseases. Therefore, the overall aim of this systematic review was to provide evidence of resistin biomarker in chronic periodontal disease which might underpin the relationship between periodontal disease, diabetes and obesity. Evidence from case-control studies are all summarized and evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Periodontal Disease
Keywords
obesity, periodontal disease, intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non Surgical Periodontal Therapy
Arm Type
Experimental
Arm Description
Will receive oral hygiene education, scaling and root planing. OHE includes brushing and flossing techniques, chlorhexidine mouth rinse twice a day
Arm Title
No Non Surgical Periodontal Therapy
Arm Type
No Intervention
Arm Description
No treatment received
Intervention Type
Other
Intervention Name(s)
Non Surgical Periodontal Therapy
Intervention Description
OHE, scaling root planing, mouth wash
Primary Outcome Measure Information:
Title
changes in clinical attachment levels (CAL) (mean CAL in mm, as a measure for periodontal parameters) following non surgical periodontal therapy
Time Frame
baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Oral health related quality of life (OHRQoL)
Time Frame
baseline to 12 weeks
Title
salivary resistin (measured in ng/ml)
Time Frame
baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Obese i.e. BMI ≥ 30 kg/m2 (WHO 1997) Age should be ≥ 30 years old Patients should have at least 12 teeth present Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nor Adinar Baharuddin, DClinDent
Organizational Affiliation
University Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry
City
Lembah Pantai
State/Province
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
10968727
Citation
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Results Reference
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PubMed Identifier
17444961
Citation
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.
Results Reference
background
PubMed Identifier
20233309
Citation
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.
Results Reference
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PubMed Identifier
16600411
Citation
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Results Reference
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PubMed Identifier
21348914
Citation
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Results Reference
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PubMed Identifier
20722533
Citation
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Results Reference
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PubMed Identifier
1679130
Citation
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.
Results Reference
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PubMed Identifier
10195925
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Citation
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.
Results Reference
derived

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Relationship Between Obesity and Periodontal Disease

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