Obesity and Oxidative Stress in Patients With Different Periodontal Status

NCT ID: NCT02508987

Last Updated: 2015-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This cross-sectional study was conducted with 93 subjects (45 normal-weight, and 48 class I obese) recruited from the Periodontology Department at the Ondokuz Mayıs University Faculty of Dentistry; Endocrinology and Metabolic Diseases Department at the Ondokuz Mayıs University Faculty of Medicine in Turkey, between September 2012 and March 2014.

The study protocol was approved by the Local Ethics Committee, and written informed consent was obtained from all study participants in accordance with the Helsinki Declaration (revised in 2000).

Oxidative stress occurs when the balance between reactive oxygen species and antioxidants become unbalanced. OS can be determined by evaluation of oxidative damage products in proteins, lipids and DNA or the reduction of total antioxidant capacity.

Malondialdehyde level is the biomarker of oxidative stress in lipids. Protein carbonyl level is the biomarker of oxidative stress in proteins.Total antioxidant capacity level is another biomarker of oxidative stress. Malondialdehyde, protein carbonyl and total antioxidant levels in crevicular fluid were examined by ELISA method.

Obesity was diagnosed according to World Health Organization criteria using body mass index. Body mass index is defined as a person's weight, in kilograms (kg), divided by the square of height in meters (m), and it is classified as follows:

≤18.49 kg/m2: Under-weight 18.50-24.99 kg/m2: Normal-weight 25.00-29.99 kg/m2: Overweight 30.00-34.9 kg/m2: Obesity class I 35.00-39.99 kg/m2: Obesity class II

≥40.00 kg/m2: Obesity class III (morbid obesity)

Periodontal status was determined through plaque index, gingival index, bleeding on probing, pocket probing depth, clinical attachment level and radiographs. Periodontal status was classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as either 'periodontally healthy', 'gingivitis' or 'generalized chronic periodontitis'. Study participants were then grouped according to body mass index and periodontal status as follows:

Group 1: Group normal weight +periodontally healthy subjects Group 2: Group normal weight + gingivitis subjects Group 3: Group normal weight + generalized chronic periodontitis subjects Group 4: Group obese + periodontally healthy subjects Group 5: Group obese + gingivitis subjects Group 6: Group obese + generalized chronic periodontitis subjects All clinical examinations and gingival crevicular fluid collection were performed by a single examiner. All laboratory procedures were performed by another researcher blinded to the study.

A total of 108 gingival crevicular fluid samples were taken from the Group 5 (18 subjects x 6 sites) and 90 samples from each of the remaining 5 groups (15 subjects per group x 6 sites). All samples were collected between 8-10 am on the day following periodontal status assessment. Samples were collected from the sites in the chronic periodontitis group that fit the following criteria: pocket probing depth≥5mm, clinical attachment level≥5mm and ≥30% radiographic alveolar bone loss. Accordingly, gingival crevicular fluid samples were collected from 2 molar teeth, 2 premolar teeth and 2 incisors. Gingival crevicular fluid samples were collected from the same 6 sites in the gingivitis and periodontally healthy groups in order to maintain consistency of sampling.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Periodontitis Gingivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

(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.

Exclusion Criteria

(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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vadim Ekrem Atabay

phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vadim E Atabay, phd

Role: PRINCIPAL_INVESTIGATOR

research assistant

References

Explore related publications, articles, or registry entries linked to this study.

Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.

Reference Type BACKGROUND
PMID: 11234459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10863370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14121956 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14158464 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PYO.DIS.1904.13.002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.