NCT02190773

Brief Summary

In the present clinical study including chronic, aggressive periodontitis and healthy individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG), Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after surgical periodontal treatment and search out the relationship of clinical parameters with these cytokine levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

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, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

3.2 years

First QC Date

July 8, 2014

Last Update Submit

July 13, 2014

Conditions

Keywords

Chronic Periodontitis, Aggressive Periodontitis, RANKL/OPG ratio, Gingival crevicular fluid

Outcome Measures

Primary Outcomes (3)

  • RANKL (pmol) level in GCF

    Changes in RANKL levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA

    Baseline-3 months

  • OPG level (pg) in GCF

    Changes in OPG levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA

    Baseline-3 months

  • RANKL/OPG ratio

    RANKL/OPG ratio changes 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis

    Baseline - 3months

Secondary Outcomes (2)

  • IL-1β (pg) levels in GCF

    Baseline, 3 months after treatment

  • Il-10 (pg) levels in GCF

    Baseline-3 months

Study Arms (3)

Chronic periodontitis

Surgical periodontal treatment and GCF collection 3 months after treatment

Agressive periodontitis

Surgical periodontal treatment and GCF collection 3 months after treatment.

Control group

Periodontally healthy individuals

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individulas that applied to periodontology clinic in faculty of dentistry, Hacettepe University.

You may qualify if:

  • Chronic periodontitis having at least 5mm or more probing depth and aggressive periodontitis patients.

You may not qualify if:

  • Any known systemic disorder, used antibiotics and/or anti-inflammatory medications, had periodontal treatment in the last 3 months and all of them were non smokers. Subjects who were lactating and pregnant were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Biospecimen

Gingival Crevicular fluid (GCF) is collected at baseline and 3 months after the surgical treatment.

MeSH Terms

Conditions

Chronic PeriodontitisAggressive Periodontitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 15, 2014

Study Start

January 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations