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Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Sponsored by
T.C. ORDU ÜNİVERSİTESİ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontitis focused on measuring Gingival Crevicular Fluid, Lipid Mediator, Periodontal Treatment

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Ordu University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Chronic Periodontitis

Arm Description

Periodontally healthy group

Patients with chronic periodontitis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prostaglandin E2 levels
change of gingival crevicular fluid and salivary Prostaglandin E2 levels from baseline at 1st month
Leukotriene B4
change of gingival crevicular fluid and salivary Leukotriene B4 levels from baseline at 1st month

Full Information

First Posted
August 2, 2019
Last Updated
August 9, 2019
Sponsor
T.C. ORDU ÜNİVERSİTESİ
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1. Study Identification

Unique Protocol Identification Number
NCT04053660
Brief Title
Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels
Official Title
Effect Of Non-Surgical Periodontal Treatment On Endogenous Anti-Inflammatory Lipid Mediators In Patients With Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Gingival Crevicular Fluid, Lipid Mediator, Periodontal Treatment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Periodontally healthy group
Arm Title
Chronic Periodontitis
Arm Type
Experimental
Arm Description
Patients with chronic periodontitis
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
Mechanical non-surgical treatment were performed
Primary Outcome Measure Information:
Title
Lipoxin A4 levels
Description
change of gingival crevicular fluid and salivary Lipoxin A4 levels from baseline at 1st month
Time Frame
1st month
Secondary Outcome Measure Information:
Title
Prostaglandin E2 levels
Description
change of gingival crevicular fluid and salivary Prostaglandin E2 levels from baseline at 1st month
Time Frame
1st month
Title
Leukotriene B4
Description
change of gingival crevicular fluid and salivary Leukotriene B4 levels from baseline at 1st month
Time Frame
1st month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ceren Gokmenoglu
Organizational Affiliation
Ordu University Faculty of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ordu University
City
Ordu
ZIP/Postal Code
52200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels

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