IL-32 Levels in Patients With Chronic Periodontitis

NCT02632981 | Completed Phase 1

• 1 other identifier: 2014-10-14-01
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis

Keywords

Interleukin-32; periodontitis

Outcome Measures

Primary Outcomes (1)

• Biochemical parameters (IL-32, IL-10 and THF-alpha)

  The changes in levels of IL-32 after periodontal treatment determined by ELISA. The changes in levels of IL-32 were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontitis.

  Baseline and 1 month after treatment

Secondary Outcomes (5)

• Probing pocket depth

  Baseline and 1 month after treatment

• Probing pocket depth and clinical attachment level

  Baseline and 1 month after treatment

• Gingival index

  Baseline and 1 month after treatment

• Plaque index

  Baseline and 1 month after treatment

• Bleeding on probing

  Baseline and 1 month after treatment

Study Arms (2)

chronic periodontitis patients

ACTIVE COMPARATOR

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

Other: nonsurgical periodontal treatment

periodontally healthy controls

PLACEBO COMPARATOR

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

Other: Gingival crevicular fluid and saliva collection

Interventions

nonsurgical periodontal treatment 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.

Also known as: chronic periodontitis patients

chronic periodontitis patients

Gingival crevicular fluid and saliva collection 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.

Also known as: periodontally healthy controls, chronic periodontitis patients

periodontally healthy controls

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bulent Ecevit University: lead

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bülent Ecevit University Faculty of Dentistry

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 17, 2015
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 17, 2015

Record last verified: 2015-12