NCT02316093

Brief Summary

Obesity may affect periodontal health by inducing gingival oxidative damage through increased production in circulating reactive oxygen species (ROS). Several studies have demonstrated that 8-OHdG in bodily fluids can act as a biomarker of oxidative DNA damage in periodontal diseases and for evaluating the effect of periodontal treatment. In the present study we hypothesized that high ROS levels in circulation may increase oxidative stress levels in the gingival crevicular fluid (GCF) and saliva in obese patients with periodontal disease, thus periodontal therapy could have positive effects on ROS levels.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Status
completed

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

March 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
Last Updated

December 12, 2014

Status Verified

December 1, 2014

Enrollment Period

10 months

First QC Date

December 10, 2014

Last Update Submit

December 10, 2014

Conditions

Outcome Measures

Primary Outcomes (2)

  • plasma, saliva and GCF levels of 8-OHdG

    baseline

  • plasma, saliva and GCF levels of 8-OHdG

    a month after periodontal treatment

Study Arms (6)

obese-chronic periodontitis patients

Other: Procedure: Gingival Crevicular Fluid, Saliva and Blood Sampling

obese-gingivitis patients

Other: Procedure: Gingival Crevicular Fluid, Saliva and Blood Sampling

obese-periodontally healthy controls

Other: Procedure: Gingival Crevicular Fluid, Saliva and Blood Sampling

normal weight-chronic periodontitis patients

Other: Procedure: Gingival Crevicular Fluid, Saliva and Blood Sampling

normal weight-gingivitis patients

Other: Procedure: Gingival Crevicular Fluid, Saliva and Blood Sampling

normal weight-periodontally healthy controls

Other: Procedure: Gingival Crevicular Fluid, Saliva and Blood Sampling

Interventions

normal weight-chronic periodontitis patientsnormal weight-gingivitis patientsnormal weight-periodontally healthy controlsobese-chronic periodontitis patientsobese-gingivitis patientsobese-periodontally healthy controls

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

a population who received periodontal treatment at the Periodontology Department

You may qualify if:

  • never-smokers
  • no history of systemic disease
  • no patients had been under periodontal treatment and medicine for at least 6 months before the study
  • no pregnancy or lactation
  • no alcohol or antioxidant vitamin consumption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Dentistry

Study Record Dates

First Submitted

December 10, 2014

First Posted

December 12, 2014

Study Start

March 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

December 12, 2014

Record last verified: 2014-12