NCT01467674

Brief Summary

The aim of this study was to investigate the impact of glycemic control on clinical periodontal status, levels of malondialdehyde (MDA), glutathione peroxidase (GSH-Px), reduced glutathione (GSH) and paraoxonase (PON) activity in gingival crevicular fluid (GCF) and blood samples of type 2 diabetes mellitus (T2DM) patients with chronic periodontitis (CP).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

1.3 years

First QC Date

November 1, 2011

Last Update Submit

November 8, 2011

Conditions

Keywords

Diabetes mellitusChronic periodontitisMalondialdehydeGlutathione peroxidaseParaoxonase

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Level of Metabolic Control

    One Year

Secondary Outcomes (1)

  • Clinical Periodontal Status

    One Year

Study Arms (4)

Healthy

Chronic Periodontitis

Better Controlled T2DM

Poor Controlled T2DM

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with T2DM were recruited among those attending Suleyman Demirel University (SDU) Faculty of Medicine, Department of Endocrinology and non-diabetic individuals were recruited among those attending SDU Faculty of Dentistry, Department of Periodontology.

You may qualify if:

  • to present T2DM diagnosis by an endocrinologist for at least the past 5 years
  • diagnosis of CP was based on the clinical and radiographic criteria proposed by the 1999 World Workshop for Classification of Periodontal Diseases and Conditions

You may not qualify if:

  • pregnancy
  • lactation
  • current smoking or smoking within the past 2 years, periodontal therapy in the previous 6 months
  • antibiotic and/or antimicrobial therapies in the previous 3 months
  • existence of serious diabetic complications or any pathology such as haemoglobinopathy which would affect haemoglobin profile
  • diagnosis of another major medical pathology, middle or upper-level obesity according to WHO classification
  • current anti-hyperlipidemic therapy
  • non-T2DM patients with abnormal values of glucose and lipid metabolism parameters, major medical pathology and family history of DM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University

Isparta, 32260, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Chronic PeriodontitisDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • F. Yeşim Kırzıoğlu, 1

    Professor, Periodontology Dept

    STUDY DIRECTOR
  • Mustafa Nazıroğlu, 1

    Professor, Biophysics Dept

    STUDY DIRECTOR
  • M. Numan Tamer, 1

    Professor, Internal Diseases Dept.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 9, 2011

Study Start

January 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations