Obesity and Oxidative Stress in Patients With Different Periodontal Status
1 other identifier
observational
93
0 countries
N/A
Brief Summary
The aim of the study is to evaluate the effect of obesity on periodontally healthy or diseased tissues.Normal weight and obese subjects were analyzed in 6 groups. Clinical periodontal status was determined through plaque index, gingival index, bleeding on probing, pocket probing depth, clinical attacment level and radiographs. Oxidative stress is known to contribute to various diseases by affecting cellular functions through the oxidation of proteins, lipids and DNA. Oxidative stress can be assessed by measuring the products of oxidative damage found in proteins, lipids and DNA or reductions in total antioxidant capacity Malondialdehyde, protein carbonyl and total antioxidant capacity levels are biomarkers of oxidative stress in gingival crevicular fluid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 22, 2015
CompletedFirst Posted
Study publicly available on registry
July 27, 2015
CompletedJuly 27, 2015
July 1, 2015
1.5 years
July 22, 2015
July 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Malondialdehyde levels in gingival crevicular fluid as measured an oxidative stress marker in lipids
Malondialdehyde is the most specific and most used molecule for measurement of biological lipid oxidation.
between 8-10 am on the day following periodontal status assessment.
Protein Carbonyl levels in gingival crevicular fluid as measured an oxidative stress marker in proteins
Protein carbonyl is another biomarker of oxidative stress
between 8-10 am on the day following periodontal status assessment.
Reduction of total antioxidant capacity levels in gingival crevicular fluid as measured an oxidative stress marker
Total antioxidant capacity provides an overview of the biological interaction between an individuals' antioxidant status and how well these antioxidants are able to protect host cells during periods of oxidative stress. Due to the potential synergistic effects of different antioxidant molecules, the measurement of total antioxidant capacity can provide a more accurate assessment of antioxidant status than the separate measurement of individual molecules.
between 8-10 am on the day following periodontal status assessment.
Secondary Outcomes (5)
Plaque index
the day before gingival crevicular fluid samples were collected
Gingival index
the day before gingival crevicular fluid samples were collected
Bleeding on probing
the day before gingival crevicular fluid samples were collected
Pocket probing depth
the day before gingival crevicular fluid samples were collected
Clinical attachment level
the day before gingival crevicular fluid samples were collected
Study Arms (6)
Group 1
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as periodontally healthy.Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 18.50-24.99 kg/m2: Normal-weight
Group 2
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as gingivitis. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 18.50-24.99 kg/m2: Normal-weight
Group 3
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as 'generalized chronic periodontitis'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index.18.50-24.99 kg/m2: Normal-weight
Group 4
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as either 'periodontally healthy'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 30.00-34.9 kg/m2: Obesity class I
Group 5
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as 'gingivitis'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 30.00-34.9 kg/m2: Obesity class I
Group 6
Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as 'generalized chronic periodontitis'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 30.00-34.9 kg/m2: Obesity class I
Eligibility Criteria
Systemically healthy 45 normal weight adults and 48 class I obese adults
You may qualify if:
- (i) ≥ 18 years of age and having ≥ 16 teeth; (ii) no periodontal therapy in the 6 months prior to data collection; (iii) no systemic problems or chemotherapy within the 6 weeks prior to data collection; (iv) no previous history of smoking.
You may not qualify if:
- (i) medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease; (ii) compromised immune system; (iii) pregnancy, menopause, or lactation; (iv) ongoing drug therapy that might affect the clinical characteristics of periodontitis; (v) use of systemic antimicrobials during the 6 weeks prior to data collection; (vi) dental treatment during the 6 months prior to data collection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
PMID: 11234459BACKGROUNDArmitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
PMID: 10863370BACKGROUNDLOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PMID: 14121956BACKGROUNDSILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
PMID: 14158464BACKGROUND
Biospecimen
gingival crevicular fluid
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vadim E Atabay, phd
research assistant
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- phd
Study Record Dates
First Submitted
July 22, 2015
First Posted
July 27, 2015
Study Start
September 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
July 27, 2015
Record last verified: 2015-07