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Completed

NCT Number: NCT04053660

Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu University

Ordu, 52200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-surgical periodontal treatment

Procedure

Mechanical non-surgical treatment were performed

Primary outcomes

  1. Lipoxin A4 levels

    Time frame: 1st month

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

Secondary outcomes

  1. Prostaglandin E2 levels

    Time frame: 1st month

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

  2. Leukotriene B4

    Time frame: 1st month

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

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

Effect Of Non-Surgical Periodontal Treatment On Endogenous Anti-Inflammatory Lipid Mediators In Patients With Chronic Periodontitis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 12, 2019
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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