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 |
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* 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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