Effect Of Non-Surgical Periodontal Treatment On Lipoxin a4 Levels

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053660
• Other study ID #: Ordu dental faculty
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2019
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Non-surgical periodontal treatment
Mechanical non-surgical treatment were performed

Locations

Country	Name	City	State
Turkey	Ordu University	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipoxin A4 levels	change of gingival crevicular fluid and salivary Lipoxin A4 levels from baseline at 1st month	1st month
Secondary	Prostaglandin E2 levels	change of gingival crevicular fluid and salivary Prostaglandin E2 levels from baseline at 1st month	1st month
Secondary	Leukotriene B4	change of gingival crevicular fluid and salivary Leukotriene B4 levels from baseline at 1st month	1st month