NCT03442920

Brief Summary

The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters \[serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)\].

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

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

December 29, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

February 9, 2018

Last Update Submit

February 21, 2018

Conditions

Periodontal DiseasesObesity

Keywords

obesityperiodontal diseasesgingival crevicular fluidsalivaserum

Outcome Measures

Primary Outcomes (2)

  • Biochemical variables GCF

    TNF-A, IL-1B,concentrations levels (pg/µl)

    12 week

  • Biochemical variables GCF

    Leptin, adiponectin, resistin concentrations levels (ng/µl)

    12 week

Secondary Outcomes (4)

  • Biochemical variables_Saliva

    12 week

  • Biochemical variables_Saliva

    12 week

  • Biochemical variables_Serum

    12 week

  • Biochemical variables_Serum

    12 week

Study Arms (2)

Obese women

EXPERIMENTAL

Obese women who participated exercise programme.

Other: Exercise

Normal weighted

NO INTERVENTION

Normal weighted women with non-periodontitis

Interventions

ExerciseOTHER

This group made exercise for 12 week/3 times a week.

Obese women

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsadult women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being women,
  • Older than 18 yrs old,
  • Not being pregnant,
  • Not being disabled,
  • For study group; being obese, not for healthy group being systemically health and in normal weight
  • Not treated periodontological in the last 6 months

You may not qualify if:

  • Younger than 18 yrs old,
  • Smokers who smokes more than 10 cigarettes in a day,
  • Uncontrolled systemic diseases,
  • Having periodontal treatment
  • who needs antibiotic prophylaxis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41190, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 22, 2018

Study Start

December 29, 2014

Primary Completion

June 11, 2015

Study Completion

January 10, 2016

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

TU(1)