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IL-34 Levels in Various Types of Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04223869
Recruitment Status : Completed
First Posted : January 10, 2020
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Seyma Bozkurt Doğan, Ankara Yildirim Beyazıt University

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

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Aggressive Periodontitis Other: non-surgical periodontal treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Critical Role of Interleukin-34 in Gingival Crevicular Fluid as a Potential Markers of Inflammation in Patients With Periodontitis
Actual Study Start Date : January 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : May 2017

Arm Intervention/treatment
No Intervention: periodontally healthy group
Control
Active Comparator: Chronic Periodontitis
non-surgical periodontal treatment was performed
Other: non-surgical periodontal treatment
scaling and root planing were performed

Active Comparator: Aggressive Periodontitis
non-surgical periodontal treatment was performed
Other: non-surgical periodontal treatment
scaling and root planing were performed




Primary Outcome Measures :
  1. gingival crevicular fluid IL-34 level [ Time Frame: 6th week ]
    gingival crevicular fluid IL-34 levels change from baseline to at 6th week


Secondary Outcome Measures :
  1. Gingival crevicular fluid RANKL level [ Time Frame: 6th week ]
    change of gingival crevicular fluid RANKL levels from baseline at 6th weeks

  2. Gingival crevicular fluid OPG level [ Time Frame: 6th week ]
    change of gingival crevicular fluid OPG levels from baseline at 6th weeks

  3. Plaque index [ Time Frame: 6th week ]
    oral hygiene score

  4. Gingival index [ Time Frame: 6th week ]
    gingival inflammation score

  5. bleeding on probing [ Time Frame: 6th week ]
    deemed positive if it occurred within 15 seconds after probing

  6. clinical attachment level [ Time Frame: 6th week ]
    distance between the cemento-enamel junction to the deepest point of periodontal pocket



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04223869


Sponsors and Collaborators
Bulent Ecevit University
Investigators
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Principal Investigator: Umut Ballı, PhD, DDS Bülent Ecevit University Faculty of Dentistry
Principal Investigator: Figen Öngöz Dede, PhD, DDS T.C. ORDU ÜNİVERSİTESİ
Study Chair: Şeyma Bozkurt Doğan, PhD, DDS Ankara Yildirim Beyazıt University
Principal Investigator: Erdim Sertoğlu, PhD, DDS Ankara Sağlık Bilimleri University
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Responsible Party: Seyma Bozkurt Doğan, Associate Professor, Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier: NCT04223869    
Other Study ID Numbers: 2014-106-03/06
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seyma Bozkurt Doğan, Ankara Yildirim Beyazıt University:
Periodontitis
Interleukin 34
RANKL
OPG
gingival crevicular fluid
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases