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CompletedNCT04053660Updated Aug 12, 2019

Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels

An interventional study of Non-surgical periodontal treatment in Periodontitis, sponsored by T.C. ORDU ÜNİVERSİTESİ. Completed at 1 site in Turkey. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-12.

Sponsored by T.C. ORDU ÜNİVERSİTESİ · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Oct 2017, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Periodontitis

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Keywords

  • Gingival Crevicular Fluid
  • Lipid Mediator
  • Periodontal Treatment
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 20 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

T.C. ORDU ÜNİVERSİTESİ is the lead sponsor of 87 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • No intervention
    Control

    Periodontally healthy group

  • Experimental
    Chronic Periodontitis

    Patients with chronic periodontitis

    Procedure: Non-surgical periodontal treatment

Interventions

  • ProcedureNon-surgical periodontal treatment

    Mechanical non-surgical treatment were performed

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What researchers measure

Primary outcomes

  1. Lipoxin A4 levels

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

    Time frame: 1st month

Secondary outcomes

  1. Prostaglandin E2 levels

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

    Time frame: 1st month

  2. Leukotriene B4

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

    Time frame: 1st month

07

Study locations

1 site
  • Ordu University
    Ordu, 52200, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04053660
Lead sponsor
T.C. ORDU ÜNİVERSİTESİ
Responsible party
Ceren Gökmenoğlu (Principal invesitgator, T.C. ORDU ÜNİVERSİTESİ) — Principal investigator
First posted
Aug 12, 2019
Start date
Oct 1, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Aug 12, 2019

Study contacts

Ceren Gokmenoglu
principal investigator · Ordu University Faculty of Dentistry

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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