IL-34 Levels in Various Types of Periodontitis

NCT04223869 | Completed

• 1 other identifier: 2014-106-03/06
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to 1) identification of the impact of IL-34 on the pathogenesis of periodontal disease and determine whether any relationship among the existing levels of Gingival crevicular fluid (GCF) Interleukin 34( IL-34 )and GCF Receptor activator of nuclear factor -kB ligand (RANKL), osteoprotegerin (OPG) and RANKL/OPG ratio, as a mediator of bone resorption 2) analysis of the impact of non-surgical periodontal treatment on GCF IL-34 levels in patients with chronic periodontitis (CP) and aggressive periodontitis (AgP) and 3) to correlate between biochemical markers and clinical recordings

Conditions

Chronic Periodontitis; Aggressive Periodontitis

Keywords

Periodontitis; Interleukin 34; RANKL; OPG; gingival crevicular fluid

Outcome Measures

Primary Outcomes (1)

• gingival crevicular fluid IL-34 level

  gingival crevicular fluid IL-34 levels change from baseline to at 6th week

  6th week

Secondary Outcomes (6)

• Gingival crevicular fluid RANKL level

  6th week

• Gingival crevicular fluid OPG level

  6th week

• Plaque index

  6th week

• Gingival index

  6th week

• bleeding on probing

  6th week

Study Arms (3)

periodontally healthy group

NO INTERVENTION

Control

Chronic Periodontitis

ACTIVE COMPARATOR

non-surgical periodontal treatment was performed

Other: non-surgical periodontal treatment

Aggressive Periodontitis

ACTIVE COMPARATOR

non-surgical periodontal treatment was performed

Other: non-surgical periodontal treatment

Interventions

non-surgical periodontal treatment OTHER

scaling and root planing were performed

Aggressive Periodontitis; Chronic Periodontitis

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• CP group included 20 patients, ≥ 35 years of age, and this category was displayed as a minimum of six teeth available clinical attachment loss (AL) and pocket probing depth (PPD) ≥ 5mm. These teeth exhibited positive bleeding on probing (BOP) across a minumum 2 separate quadrants and bone loss affecting \>30 % of available teeth on clinical and radiographic inspection. The gingival index (GI) score for indications of inflammation (red color and edema of the gingival margin) was \>1 for the CP group.
• AgP group included 20 patients, \<35 years of age, and cases showed PPD≥ 5mm with at least six teeth and radiographic evidence of alveolar bone loss. At least three of these six teeth with PPD ≥ 5 mm were not molars or incisors. These patients showed severe periodontal tissue devastation and decrease of periodontal support conflicting with age and plaque levels.
• Control group included 20 participants and they presented PPD ≤ 3mm, GI=0 (nonavailable of clinical inflammation), absence of alveolar bone loss (e.g., distance between the cemento-enamel junction and the bone crest was \<3mm in\> 95% of proximal tooth sites).
• All participants had minimum 20 teeth and their overall systematic health

You may not qualify if:

• lactation
• pregnancy
• current and ex-smoking habits
• undergone nonsurgical periodontal therapy and prescription of antibiotics or non-steroidal anti-inflammatory medication within the previous 6 months or surgical periodontal treatment within the preceding year
• postmenopause
• systemic conditions such as; diabetes mellitus, cancer, cardiovascular and respiratory diseases, rheumatoid arthritis, osteoporosis, or immunologic disorders, that might cause progress of periodontal disease.

Sponsors & Collaborators

• Bulent Ecevit University: lead

MeSH Terms

Conditions

Chronic Periodontitis; Aggressive Periodontitis; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Umut Ballı, PhD, DDS

  Bülent Ecevit University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Figen Öngöz Dede, PhD, DDS

  Ordu University

  PRINCIPAL INVESTIGATOR

• Şeyma Bozkurt Doğan, PhD, DDS

  Ankara Yildirim Beyazıt University

  STUDY CHAIR

• Erdim Sertoğlu, PhD, DDS

  Ankara Sağlık Bilimleri University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 10, 2020
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2017
• Last Updated: January 10, 2020

Record last verified: 2020-01