NCT03923218

Brief Summary

The aims of our study were 1) to evaluate levels of gingival crevicular fluid( GCF) human cathelicidin peptide LL-37 and serum vitamin D3 in smoker and non-smoker patients with chronic periodontitis(CP) 2) to determine whether any correlation between GCF LL-37 and vitamin D3 serum levels exist and 3) to asses the correlation between clinical parameters and biochemical markers

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2011

Typical duration 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

December 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

April 17, 2019

Last Update Submit

April 19, 2019

Conditions

Keywords

Gingival crevicular fluidVitamin DLL-37Serumperiodontitis

Outcome Measures

Primary Outcomes (2)

  • Serum D3 Vitamin levels

    The plasma levels of vitamin D3 were greater in the CP-2 group than in the CP-1 group. But, no statistically significant difference was determined between the CP groups (P\>0.05)

    Baseline

  • Gingival Crevicular fluid(GCF) LL-37 levels

    The concentration of LL-37 in GCF was significantly higher in both of the CP groups than in the CTRL group (p\<0.001). Although GCF LL-37 concentration levels were greater in the CP-1 group than in the CP-2 group, the difference did not reach the statistical significance between the CP groups (p\>0.05).

    Baseline

Secondary Outcomes (5)

  • Plaque index (PI)

    Baseline

  • GCF volume

    Baseline

  • gingival index (GI)

    Baseline

  • Probing depth (PD)

    Baseline

  • Clinical attachment level (CAL)

    Baseline

Study Arms (3)

Smoker patients with chronic periodontitis

Smoker patients with chronic periodontitis

Other: LL-37 levels in Gingival crevicular fluidOther: Serum Vitamin D3 levelsOther: Clinical parameters

non-smoker patients with chronic periodontitis

non-smoker patients with chronic periodontitis

Other: LL-37 levels in Gingival crevicular fluidOther: Serum Vitamin D3 levelsOther: Clinical parameters

periodontally healthy patients

periodontally healthy patients

Other: LL-37 levels in Gingival crevicular fluidOther: Serum Vitamin D3 levelsOther: Clinical parameters

Interventions

Collected gingival crevicular fluid

Smoker patients with chronic periodontitisnon-smoker patients with chronic periodontitisperiodontally healthy patients

Collected serum

Smoker patients with chronic periodontitisnon-smoker patients with chronic periodontitisperiodontally healthy patients

Recorded plague index, gingival index, probing depth, clinical attachment level

Smoker patients with chronic periodontitisnon-smoker patients with chronic periodontitisperiodontally healthy patients

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The volunteers participitating in the study were choosen from among individuals scheduled to undergo either dental treatment or dental check at the Deparment of Perioodontology, Faculty of Dentistry, Gazi University, Ankara, Turkey.

You may qualify if:

  • Clinical attachment loss ≥ 5mm
  • Probing depth ≥5mm
  • Bone loss affecting \>30% of the existing teeth on clinical and radiographic examination
  • gingival index (GI) score\> 1
  • full-mouth PD was≤ 3mm,
  • Gingival index \<1
  • there was no indication of Attachment Loss or no radiographic evidence of alveolar bone loss in control group.
  • Non-smokers.
  • Smoking criteria for groups:
  • patients smoked more than 10 cigarettes in a day
  • smoking for 3 or more years,

You may not qualify if:

  • systemic condition (diabetes, cardiovascular disease, immunologic disorders, hepatitis, e.g.)
  • pregnancy, lactation or menopause term,
  • antibiotic treatment or non-steroidal anti-inflammatory medications within the last 3 months before the study,
  • non-surgical periodontal treatment during the last 6 months before the study,
  • treatment with Vitamin D supplementation before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Şeyma BOZKURT DOĞAN, Professor

    university

    PRINCIPAL INVESTIGATOR
  • Elifcan Kıvrak, PhD

    university

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 22, 2019

Study Start

December 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2015

Last Updated

April 22, 2019

Record last verified: 2019-04