- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04053660
Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels
August 9, 2019 updated by: Ceren Gökmenoğlu, T.C. ORDU ÜNİVERSİTESİ
Effect Of Non-Surgical Periodontal Treatment On Endogenous Anti-Inflammatory Lipid Mediators In Patients With Chronic Periodontitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ordu, Turkey, 52200
- Ordu University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Periodontally healthy group
|
|
Experimental: Chronic Periodontitis
Patients with chronic periodontitis
|
Mechanical non-surgical treatment were performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipoxin A4 levels
Time Frame: 1st month
|
change of gingival crevicular fluid and salivary Lipoxin A4 levels from baseline at 1st month
|
1st month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prostaglandin E2 levels
Time Frame: 1st month
|
change of gingival crevicular fluid and salivary Prostaglandin E2 levels from baseline at 1st month
|
1st month
|
Leukotriene B4
Time Frame: 1st month
|
change of gingival crevicular fluid and salivary Leukotriene B4 levels from baseline at 1st month
|
1st month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ceren Gokmenoglu, Ordu University Faculty of Dentistry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
August 2, 2019
First Submitted That Met QC Criteria
August 9, 2019
First Posted (Actual)
August 12, 2019
Study Record Updates
Last Update Posted (Actual)
August 12, 2019
Last Update Submitted That Met QC Criteria
August 9, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ordu dental faculty
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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