NCT04053660

Brief Summary

The aim of this study was to evaluate the levels of lipoxin A4 (LXA4), prostaglandin E2 (PGE2) and leukotriene B4 (LTB4) in gingival crevicular fluid (GCF) and saliva in individuals with periodontal healthy and chronic periodontitis. In addition, the investigators evaluated the levels of these mediators after non-surgical periodontal treatment in patients with chronic periodontitis. A total of 20 subjects, 10 patients with chronic periodontitis (CP) and 10 periodontally healthy individuals were included in the study. Clinical parameters including plaque index (PI), gingival index (GI), probing depth (PD) and clinical attachment levels (CAL) were recorded. GCF and saliva samples were obtained at the beginning of the study from all individuals. GCF and saliva samples were re-collected from patients with CP at 1 month after non surgical periodontal therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

August 2, 2019

Last Update Submit

August 9, 2019

Conditions

Keywords

Gingival Crevicular FluidLipid MediatorPeriodontal Treatment

Outcome Measures

Primary Outcomes (1)

  • Lipoxin A4 levels

    change of gingival crevicular fluid and salivary Lipoxin A4 levels from baseline at 1st month

    1st month

Secondary Outcomes (2)

  • Prostaglandin E2 levels

    1st month

  • Leukotriene B4

    1st month

Study Arms (2)

Control

NO INTERVENTION

Periodontally healthy group

Chronic Periodontitis

EXPERIMENTAL

Patients with chronic periodontitis

Procedure: Non-surgical periodontal treatment

Interventions

Mechanical non-surgical treatment were performed

Chronic Periodontitis

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have at least 20 natural teeth, excluding third molars.
  • Chronic periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting \>30% of the teeth, as detected on clinical and radiographical examinations.
  • Periodontally healthy control group had no sign of gingival inflammation, no PD \> 3mm and no evidence of attachment or bone loss.

You may not qualify if:

  • History of systemic disease.
  • Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.
  • Periodontal treatment during last 6 months that could affect periodontal status.
  • Smoking.
  • History of radiotherapy or chemotherapy.
  • Ongoing orthodontic treatment.
  • Aggressive periodontitis.
  • Current pregnancy, lactation or menopause.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Ceren Gokmenoglu

    Ordu University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

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
Principal invesitgator

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 12, 2019

Study Start

October 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations