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IL-34 Levels in Various Types of Periodontitis

Primary Purpose

Chronic Periodontitis, Aggressive Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
non-surgical periodontal treatment
Sponsored by
Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Periodontitis, Interleukin 34, RANKL, OPG, gingival crevicular fluid

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    periodontally healthy group

    Chronic Periodontitis

    Aggressive Periodontitis

    Arm Description

    Control

    non-surgical periodontal treatment was performed

    non-surgical periodontal treatment was performed

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Gingival crevicular fluid RANKL level
    change of gingival crevicular fluid RANKL levels from baseline at 6th weeks
    Gingival crevicular fluid OPG level
    change of gingival crevicular fluid OPG levels from baseline at 6th weeks
    Plaque index
    oral hygiene score
    Gingival index
    gingival inflammation score
    bleeding on probing
    deemed positive if it occurred within 15 seconds after probing
    clinical attachment level
    distance between the cemento-enamel junction to the deepest point of periodontal pocket

    Full Information

    First Posted
    January 8, 2020
    Last Updated
    January 8, 2020
    Sponsor
    Bulent Ecevit University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04223869
    Brief Title
    IL-34 Levels in Various Types of Periodontitis
    Official Title
    Critical Role of Interleukin-34 in Gingival Crevicular Fluid as a Potential Markers of Inflammation in Patients With Periodontitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bulent Ecevit University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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
    Detailed Description
    A novel cytokine interleukin 34 (IL-34) is a second possible functional ligand of macrophage colony-stimulating factor-1 receptor (CSF-1R). IL-34 is secreted in different tissues including: heart, brain, lung, liver, kidney, thymus, testes, ovary, small intestine, prostate, colon and spleen . IL-34 shares vital functions of macrophage colony-stimulating factor -1(CSF-1), and manage myeloid cell survival, differentiation and proliferation. It is produced by synovial fluid, gingival fibroblast and human adipose tissue, and is controlled by the transcription factor RANK and activation of c-Jun N-terminal kinase (CJNK). Additionally, the pro-inflammatory cytokines tumornecrosis factor-alfa (TNF-α) and interleukin-1beta (IL-1β) arrange IL-34 release from gingival fibroblasts, by a mechanism including nuclear factor -kB (NF-kB) and mitogen activated protein kinase (MAPK).The targeting CSF-1 merely is not adequate to inhibit the effect via CSF-1R. Moreover, neither RANKL nor IL-34 solely can cause osteoclast formation which suggests that IL-34 is required but not enough. IL-34 plays a crucial role in RANKL-induced osteoclastogenesis; the osteoclasts differentiation is mediated by the same way with CSF-1. Several studies evaluated the role of IL-34 in the pathogenesis of chronic periodontitis (CP). To the best of our knowledge, any of these studies reported the relationship between GCF IL-34 level and GCF RANKL/OPG ratio in other types of periodontitis before and after non-surgical periodontal therapy. This study highlights the influence of IL-34 in the pathogenesis of Chronic Periodontitis (CP) and Aggressive Periodontitis (AgP). 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 GCF IL-34 and GCF RANKL, 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 CP and AgP and 3) to correlate between biochemical markers and clinical recordings. The study included 60 subjects: 20 who were periodontally healthy (CTRL), 20 with chronic periodontitis (CP)and 20 with aggressive periodontitis (AgP). Patients with periodontitis were treated with non-surgical periodontal therapy. GCF sampling procedures and clinical periodontal measures were investigated at the baseline and 6 weeks after treatment. Levels of IL-34, RANKL and OPG were analyzed with Enzyme-linked immunosorbent assay (ELISA). Participants were periodontally assessed at baseline and after non-surgical periodontal therapy in accordance with the following criteria; plaque index (PI)(Silness and Loe, 1964), GI(Loe and Silness, 1963), PPD, clinical attachment level (CAL) and BOP (judged positive if it developed within 15 s following contact). Full-mouth periapical radiographs were used to determine the periodontal bone loss.The clinical measurement were taken in millimeters by a single calibrated examiner (ŞBD), who was blinded to the whole study composition, from six locations of each tooth (mesio-buccal, disto-buccal, mid-buccal, mesiolingual, disto-lingual, and mid-lingual), by the use of a periodontal probe (Hu-Friedy, Chicago, IL, USA). Two sites per participant were selected to collect GCF for each group. GCF samples were collected from the mesiobuccal or distobuccal sites of single-rooted teeth. The sample areas were isolated with cotton rolls, saliva contamination was ensured, all supragingival plaque was eliminated by sterile curette and it was slightly air dried. The paper strips were inserted within the crevice until resistance was encountered and then allowed to remain in place for 30 seconds. The amount of GCF on the strips was measured by weighing the collected liquid. The strips were placed into closed and numbered plastic eppendorf tubes. The liquid was weighed again, immediately after collection, to take into account evaporation. The samples consisting of saliva and blood were discarded from the study. Two available for use samples from per individual were merged to make a singular sample and instantly insert in a singular Eppendorf tube and freezed at _80°C until aftertime evaluation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis, Aggressive Periodontitis
    Keywords
    Periodontitis, Interleukin 34, RANKL, OPG, gingival crevicular fluid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    periodontally healthy group
    Arm Type
    No Intervention
    Arm Description
    Control
    Arm Title
    Chronic Periodontitis
    Arm Type
    Active Comparator
    Arm Description
    non-surgical periodontal treatment was performed
    Arm Title
    Aggressive Periodontitis
    Arm Type
    Active Comparator
    Arm Description
    non-surgical periodontal treatment was performed
    Intervention Type
    Other
    Intervention Name(s)
    non-surgical periodontal treatment
    Intervention Description
    scaling and root planing were performed
    Primary Outcome Measure Information:
    Title
    gingival crevicular fluid IL-34 level
    Description
    gingival crevicular fluid IL-34 levels change from baseline to at 6th week
    Time Frame
    6th week
    Secondary Outcome Measure Information:
    Title
    Gingival crevicular fluid RANKL level
    Description
    change of gingival crevicular fluid RANKL levels from baseline at 6th weeks
    Time Frame
    6th week
    Title
    Gingival crevicular fluid OPG level
    Description
    change of gingival crevicular fluid OPG levels from baseline at 6th weeks
    Time Frame
    6th week
    Title
    Plaque index
    Description
    oral hygiene score
    Time Frame
    6th week
    Title
    Gingival index
    Description
    gingival inflammation score
    Time Frame
    6th week
    Title
    bleeding on probing
    Description
    deemed positive if it occurred within 15 seconds after probing
    Time Frame
    6th week
    Title
    clinical attachment level
    Description
    distance between the cemento-enamel junction to the deepest point of periodontal pocket
    Time Frame
    6th week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Umut Ballı, PhD, DDS
    Organizational Affiliation
    Bülent Ecevit University Faculty of Dentistry
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Figen Öngöz Dede, PhD, DDS
    Organizational Affiliation
    T.C. ORDU ÜNİVERSİTESİ
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Şeyma Bozkurt Doğan, PhD, DDS
    Organizational Affiliation
    Ankara Yildirim Beyazıt University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Erdim Sertoğlu, PhD, DDS
    Organizational Affiliation
    Ankara Sağlık Bilimleri University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    IL-34 Levels in Various Types of Periodontitis

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