Evaluation of IL-17, TNF-alpha, RANKL Levels in Gingival Cervicular Fluid
1 other identifier
observational
40
0 countries
N/A
Brief Summary
Inflammatory process begins around root apex as a result of bacterial infection of pulp cavity in chronic apical periodontitis. Bone destruction can begin in apical region after immunological reactions at the end of inflammatory process, and radiolucent periapical lesion seems in this way. If bone destruction around apical region is in the rate of 30%, we can notice this difference eventually. Histological manifestations of periapical inflammation can be observed in the result of pulp necrosis and inflammation around apical region. Mocelular methods can determine the type of therapy in various diseases. Each region and tissue reserve specific host factors. Vast majority of pulpal inflammation was trigerred by microorganisms. Certain bacterial virulence factors may damage host tissue directly, other virulence factors can stimulate prolonged non-specific immune response causing tissue damage. In the last phase of infection, immunopathological destruction of pulp tissue is observed due to humoral response. IL-17 is an important inflammatory cytokine released from T cells of the immune system. TNF-alpha and RANKL are also mediators responsible for bone destruction metabolism. TNF is a cytokine mediating immunologic changes during periodontal disease. TNF induction stimulate secondary mediators taking part as chemotactic cytokines. TNF has two different types; TNF-alpha and TNF-beta. TNF-alpha is a polypeptide cytokine produced by macrophages and monocytes. TNF-alpha stimulates bone resorption . There has been limited researches analyzing GCF, blood and tissue of pulp, dentin-derived fluid and periapical fluid for molecular diagnosis so far. GCF is a fluid derived from gingival groove. This fluid contains a lot of host factors such as anticor, bacterial antigen, protein and cytokines. GCF sampling is a non-invasive method, it can be used to provide diagnostic information in all clinical cases. In this study, we will evaluate the levels of IL-17, TNF-alpha and RANKL in the gingival crevicular fluid of teeth with periapical lesion diagnosed with chronic apical periodontitis. Thus, it will be evaluated whether these markers can be used for diagnosis and follow-up of the disease in teeth with periapical lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2022
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2022
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedFebruary 10, 2022
February 1, 2022
2 months
January 17, 2022
February 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
IL-17 Level
Concentration of IL-17 in GCF
6 months
TNF-alpha
Concentration of TNF-alpha in GCF
6 months
RANKL
Concentration of RANKL in GCF
6 months
Study Arms (2)
1
GCF samples will be taken from the teeth diagnosed with chronic apical periodontitis
2
GCF samples will be taken from the collateral teeth (healthy teeth) of the teeth diagnosed with chronic apical periodontitis.
Interventions
GCF samples will be taken from the teeth diagnosed with chronic apical periodontitis
Eligibility Criteria
It is planned to include volunteer patients who came to Van YYU Faculty of Dentistry, Oral and Maxillofacial Radiology Department for routine examination.
You may qualify if:
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis and periapical lesion
You may not qualify if:
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
- Teeth with immature/open apex
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Newton CW, Hoen MM, Goodis HE, Johnson BR, McClanahan SB. Identify and determine the metrics, hierarchy, and predictive value of all the parameters and/or methods used during endodontic diagnosis. J Endod. 2009 Dec;35(12):1635-44. doi: 10.1016/j.joen.2009.09.033.
PMID: 19932338RESULTRicucci D, Siqueira JF Jr, Bate AL, Pitt Ford TR. Histologic investigation of root canal-treated teeth with apical periodontitis: a retrospective study from twenty-four patients. J Endod. 2009 Apr;35(4):493-502. doi: 10.1016/j.joen.2008.12.014.
PMID: 19345793RESULT
Biospecimen
The gingival cervicular fluid is a biological fluid originating from blood plasma, present in different compositions in the gingival sulcus, and has the characteristics of exudate, which determines the ecology of the gingival sulcus. Cellular components (epithelium, bacteria, leukocytes, erythrocytes, leukocytes, viruses and their by-products), electrolytes, bacterial-metabolic products, cytokines, host and bacterial enzymes and enzyme products-inhibitors (acid phosphatase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, aryl sulfatase, etc.), and immunoglobulins form the characteristic features of the fluid, revealing the importance of this fluid in terms of periodontal disease.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asist. Prof.
Study Record Dates
First Submitted
January 17, 2022
First Posted
February 10, 2022
Study Start
February 1, 2022
Primary Completion
March 30, 2022
Study Completion
April 30, 2022
Last Updated
February 10, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share