IL-32 Levels in Patients With Chronic Periodontitis

NCT ID: NCT02632981

Last Updated: 2015-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

Brief Summary

Interleukin-32 (IL-32) is a recently described cytokine that is a strong inducer of pro-inflammatory cytokines such as tumor necrosis factor (TNF)-α. A previous report have reported that Porphyromonas gingivalis-derived LPS significantly up-regulated IL-32 expression compared with the unstimulated cells in monocytes (THP-1 cells). They suggested that IL-32 may contribute to the pathogenesis of periodontal disease. In the present study the investigators hypothesized that IL-32 levels may increase in the gingival crevicular fluid (GCF) and saliva of patients with chronic periodontitis compared with healthy controls and these levels may decrease together with treatment.

Detailed Description

The purpose of this study was to investigate IL-32 levels in the GCF and saliva of patients with chronic periodontitis and to evaluate changes after nonsurgical periodontal therapy.

Twenty-seven CP and 27 periodontally healthy controls were enrolled in this study. Periodontitis patients received nonsurgical periodontal treatment. GCF and saliva sampling and clinical periodontal parameters were assessed before and a month after treatment. IL-32, IL-10 and TNF-α levels in GCF and saliva were measured by enzyme-linked immunosorbent assay.

Unstimulated salivary samples were collected using standard techniques. About 2 mL whole saliva was collected in disposable tubes and centrifuged immediately to remove cell debris (10,000 g x 10 minutes). The supernatants (50µL each) were stored at -40C until analyzed. GCF samples were collected from a mesio-buccal and disto-palatal site on each tooth. In the CP group, the samples were obtained from patients at areas with ≥5 mm CAL, ≥6 mm PD and ≥30% bone loss. In the healthy group, GCF samples were collected from teeth exhibiting PD<3 mm without CAL and BOP. The area was isolated with cotton rolls, saliva contamination elimination was ensured, and it was slightly air dried. GCF was sampled with paper strips. Paper strips were placed into the crevice until mild resistance was felt (intracrevicular method) and left in the position for 30 seconds. Strips contaminated with blood or saliva were discarded. Each sampled strip was placed into a 400µl eppendorf centrifuge tube and stored at -40C until analyzed.

Conditions

Periodontitis

Keywords

Interleukin-32; periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

chronic periodontitis patients

gingival crevicular fluid and saliva collecion were taken before and after nonsurgical periodontal treatment

Group Type: ACTIVE_COMPARATOR

nonsurgical periodontal treatment

Intervention Type: OTHER

Scaling and root planning under local anaesthesia, in a total of four clinical visits Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.

periodontally healthy controls

gingival crevicular fluid and saliva collection were taken at baseline after oral hygiene instructions

Group Type: PLACEBO_COMPARATOR

Gingival crevicular fluid and saliva collection

Intervention Type: OTHER

GCF collection with filter paper (Periopaper) using the intracrevicular method. Patients' mouths were rinsed with distilled water, and unstimulated salivary samples were collected by patients expectorating into disposable tubes.

Interventions

nonsurgical periodontal treatment

Scaling and root planning under local anaesthesia, in a total of four clinical visits Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.

Intervention Type: OTHER

Gingival crevicular fluid and saliva collection

GCF collection with filter paper (Periopaper) using the intracrevicular method. Patients' mouths were rinsed with distilled water, and unstimulated salivary samples were collected by patients expectorating into disposable tubes.

Intervention Type: OTHER

Other Intervention Names

chronic periodontitis patients; periodontally healthy controls; chronic periodontitis patients

Eligibility Criteria

Inclusion Criteria

• all subjects in the study were possess of at least 20 teeth excluding third molars.

Exclusion Criteria

• agressive periodontitis,
• periapical pathologies,
• excessive forces including mechanical forces caused by orthodontic forces and occlusal forces;
• presence of systemic diseases;
• administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 6 months;
• need for antibiotic prophylaxis for dental treatment and having received non-surgical periodontal treatment within the past 6 months or surgical periodontal treatment within the past 12 months;
• allergy or sensitivity to any drug,
• pregnancy,
• lactation, and
• current and former use of tobacco.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bulent Ecevit University

OTHER

Sponsor Role: lead

Responsible Party

Figen ÖNGÖZ DEDE

Bülent Ecevit University Faculty of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2014-10-14-01

Identifier Type: -

Identifier Source: org_study_id