NCT04115176

Brief Summary

This study was performed to evaluate the effects of both periodontal treatment and smoking on the gingival crevicular fluid(GCF) levels of interleukin (IL)-17A, IL-17E, Total oxidative stress(TOS) and total antioxidant capasity(TAOC) in smoking and non-smoking patients with severe chronic periodontitis. Systemically healthy 15 smoker,15 non-smoker with chronic periodontitis were attended for the study. Periodontal status were determined by recording periodontal clinical measurements. GCF samples were collected at the baseline, at the end of initial periodontal treatment and 4 weeks after periodontal flap surgery. The data were tested statistically by the Student t and paired sample t tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

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

October 10, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

October 2, 2019

Last Update Submit

October 3, 2019

Conditions

Keywords

chronic periodontitissmoking,periodontal treatment,IL-17,oxidative stress

Outcome Measures

Primary Outcomes (4)

  • GCF IL-17A VOLUME

    IL-17A is a cytokine present in gingival crevicular fluid. Its volume calculated as microliter and changes due to inflammation caused by periodontal disease.

    GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .

  • GCF IL-17E VOLUME

    IL-17E is a cytokine present in gingival crevicular fluid. Its volume calculated as microliter and changes due to inflammation caused by periodontal disease.

    GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .

  • GCF TOTAL OXIDATIVE STRESS (TOS) LEVEL

    TOS is the measurement of oxidative stress amount and given as mmol/L unit. Its amount changes due to inflammation caused by periodontal disease.

    GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .

  • GCF TOTAL ANTIOXIDANT CAPASITY (TAOC)

    TAOC is the antioxidant amount measured and given as μmol H2O2 Eq/L unit. Its amount changes due to inflammation caused by periodontal disease.

    GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .

Study Arms (2)

smokers + periodontitis

Individuals clinically diagnosed with chronic periodontitis that smoke recruited for this group.

nonsmoker + periodontitis

Individuals clinically diagnosed with chronic periodontitis that don't smoke recruited for this group.

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with chronic periodontitis (with an age range of 35 to 60 years) seeking dental treatment at the Periodontology Clinic, School of Dentistry, Ondokuz Mayis University, were included in the present study.

You may qualify if:

  • individuals aged ˃35 years and having ≥16 teeth diagnosed as chronic periodontitis
  • not received any periodontal therapy within the previous 6 months;
  • not received antibiotic/anti-inflammatory drug treatment within the previous 6 months.

You may not qualify if:

  • receiving medical treatment for cancer, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, or any other systemic disease;
  • being pregnant or being in the period of menopause or lactation;
  • receiving any drug therapy that might affect the clinical characteristics of periodontitis;
  • usage of systemic antimicrobials during the 6 weeks prior to data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Müge Lütfioğlu

Samsun, Atakum, 55039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic PeriodontitisCigarette SmokingSmoking

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsTobacco SmokingBehaviorTobacco Use

Study Officials

  • MÜGE LÜTFİOĞLU

    assoc. prof.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 3, 2019

Study Start

October 10, 2017

Primary Completion

July 10, 2019

Study Completion

July 10, 2019

Last Updated

October 4, 2019

Record last verified: 2019-10

Locations