Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels
1 other identifier
interventional
20
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
August 2, 2019
CompletedFirst Posted
Study publicly available on registry
August 12, 2019
CompletedAugust 12, 2019
August 1, 2019
1.2 years
August 2, 2019
August 9, 2019
Conditions
Keywords
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 INTERVENTIONPeriodontally healthy group
Chronic Periodontitis
EXPERIMENTALPatients with chronic periodontitis
Interventions
Mechanical non-surgical treatment were performed
Eligibility Criteria
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
- Ordu Universitylead
Study Sites (1)
Ordu University
Ordu, 52200, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ceren Gokmenoglu
Ordu University Faculty of Dentistry
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