NCT02498561

Brief Summary

Obesity may affect periodontal health by inducing gingival oxidative damage through increased production in circulating reactive oxygen species (ROS). Previous studies have reported decreased glutathione levels in patients with periodontitis when compared to healthy subjects in gingival crevicular fluid (GCF), plasma and saliva. In the present study we hypothesized that high ROS levels in circulation may decrease glutathione levels in the GCF,plasma and saliva in obese patients with chronic periodontitis, whereas periodontal therapy could have positive effects on glutathione levels.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 obesity

Timeline
Completed

Started Mar 2013

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
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

10 months

First QC Date

July 9, 2015

Last Update Submit

July 14, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Biochemical parameters (GSH and GSSG levels, GSH/GSSG ratio )

    The changes in levels of reduced and oxidized glutathione (GSH and GSSG) 1 month after periodontal treatment determined by ELISA. The changes in levels of GSH were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontitis and obesity.

    Baseline and 1 month after treatment

Secondary Outcomes (5)

  • Probing pocket depth

    Baseline and 1 month after treatment

  • Probing pocket depth and clinical attachment level

    Baseline and 1 month after treatment

  • Gingival index

    Baseline and 1 month after treatment

  • Plaque index

    Baseline and 1 month after treatment

  • Bleeding on probing

    Baseline and 1 month after treatment

Study Arms (4)

obese-chronic periodontitis patients

ACTIVE COMPARATOR

GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy

Procedure: nonsurgical periodontal therapy

obese-periodontally healthy controls

PLACEBO COMPARATOR

GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions

Procedure: oral hygiene instructions

normal weight-CP patients

ACTIVE COMPARATOR

GCF, plasma and GCF samples were taken before and after nonsurgical periodontal therapy

Procedure: nonsurgical periodontal therapy

normal weight-PH controls

PLACEBO COMPARATOR

GCF, plasma and GCF samples were taken at baseline after oral hygiene instructions

Procedure: oral hygiene instructions

Interventions

nonsurgical periodontal therapyPROCEDURE

Scaling and root planning under local anaesthesia, in a total of four clinical visits Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.

Also known as: obese-chronic periodontitis patients
obese-chronic periodontitis patients
oral hygiene instructionsPROCEDURE

Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush

Also known as: obese-periodontally healthy controls
obese-periodontally healthy controls

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • never-smokers
  • no history of systemic disease
  • no patients had been under periodontal therapy 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

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Faculty of Dentistry

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 15, 2015

Study Start

March 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 16, 2015

Record last verified: 2015-07