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
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
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
NCT ID
NCT04223869
First Posted
January 8, 2020
Last Updated
January 8, 2020
Sponsor
Bulent Ecevit University
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
Learn more about this trial
IL-34 Levels in Various Types of Periodontitis
We'll reach out to this number within 24 hrs