The Effects of Obesity on Non Surgical Periodontal Therapy (EONSPT)

November 26, 2015 updated by: University of Malaya
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity is a health concern, associated with complex diseases such as diabetes, hypertension as well as chronic periodontitis. The prevalence is estimated as 24% worldwide, 3% for South East Asia, and 27.2% for Malaysia. Prevalence of CP is increasing, with 10-15% reported in various adult populations and estimated 5-20% categorised as severe CP. In Malaysia, the prevalence of severe CP is estimated as 18%.

The first paper on the relationship between obesity and periodontal disease reported that obese-hypertensive rats are more likely to have periodontal tissue deterioration than normal rats. Subsequent study reported an induction of expression of Tumour Necrosis Factor (TNF) -a gene in obese mice and thus proposed TNF-α represents a key mediator of obesity-linked insulin resistance. This was strongly supported by an extension study on human adipose tissue. A model was proposed linking inflammation to obesity, diabetes, and periodontal infection in 2005. Subsequent studies found association between obesity and increased risk for CP in the United States, Japanese and Jordanian adult populations.

Adipose tissue produces a number of adipokines linked to inflammation, including adiponectin, interleukin (IL)-1β, IL-6, TNF-α, Monocyte Chemoattractant Protein (MCP)-1 and Macrophages Migrant Inhibitory Factor (MIF). Increased in circulating levels of pro-inflammatory cytokines such as TNF-α and IL-6 are strongly correlated with obesity, insulin resistance, hyperglycemia and diabetes mellitus. These cytokines also stimulate the synthesis of C-reactive protein (CRP) and fibrinogen by liver, as CRP is known for its role in inflammation, atherosclerosis and insulin resistance. In addition, these cytokines are also secreted from adipose tissues are involved in the pathophysiology of both obesity and periodontitis. Obese individuals have higher levels of circulating TNF-α and IL-6 when compared to normal weight individuals. This may increase the risk of destructive periodontal diseases development. Interestingly, studies on the immune response to periodontal pathogens showed that TNF-α enhanced the immune response to these pathogens.

Periodontal health is accomplished through non-surgical periodontal therapy (NSPT), which includes oral hygiene education (OHE) and scaling and root planing (SRP). NSPT has been reported to effectively reduce microbial load and contributes to reduction in periodontal parameters and inflammatory burden up to 6 months post-therapy. In a general population, NSPT has been shown to induce a shift from a pre-dominant gram-negative to a gram-positive subgingival microbiota. The total bacteria count and positives sites of Porphyromonas gingivalis (P gingivalis) and Tannerella forsythia (T forsythia) were significant decreased in treated group compared to control groups. In addition, SRP has markedly reduced these periodontal pathogens: Porphyromonas gingivalis, Tannerella forsythia as well as Prevotella intermedia 24 months post NSPT.

Molecular mechanisms between inflammatory cytokines and CP are unclear and warrant further studies to determine whether pro-inflammatory cytokines is the pathogenic factor linking obesity to periodontal infections. To date, there are not many studies that examine the changes in periodontal pathogen, salivary and serum interleukins levels in obese patients with CP following NSPT. Further prospective studies are needed to address this issue and to determine stronger evidence on the association between obesity, periodontal diseases and potential mediating factors following NSPT.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese with CP
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
NSPT includes oral hygiene education, scaling root planing and mouth wash
Other Names:
  • NSPT
Active Comparator: Non obese with CP
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
NSPT includes oral hygiene education, scaling root planing and mouth wash
Other Names:
  • NSPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Nor_Adinar Baharuddin, DClinDent, Faculty of Dentistry University of Malaya Kuala Lumpur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 26, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Estimate)

December 1, 2015

Last Update Submitted That Met QC Criteria

November 26, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101269-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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