NCT02508987

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

July 22, 2015

Last Update Submit

July 23, 2015

Conditions

Keywords

Obesityoxidative stressantioxidantsperiodontal disease

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

Age35 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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: 11234459BACKGROUND
  • Armitage 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: 10863370BACKGROUND
  • LOE 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: 14121956BACKGROUND
  • SILNESS 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

Retention: SAMPLES WITHOUT DNA

gingival crevicular fluid

MeSH Terms

Conditions

ObesityPeriodontitisGingivitisPeriodontal Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Officials

  • Vadim E Atabay, phd

    research assistant

    PRINCIPAL INVESTIGATOR

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