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TNF-α/HIF-1α/VEGF Pathway in Periodontal Diseases

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ClinicalTrials.gov Identifier: NCT03558906
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborators:
Celal Bayar University
Ege University
Information provided by (Responsible Party):
Beral Afacan, Adnan Menderes University

Brief Summary:
This study aimed to investigate gingival crevicular fluid (GCF) and salivary hypoxia inducible factor-1 alpha (HIF-1α), vascular endothelial growth factor (VEGF) and tumor necrosis factor-alpha (TNF-α) levels in different periodontal diseases. A total of 87 individuals, 20 patients with generalized aggressive periodontitis, 20 with chronic periodontitis, 26 with gingivitis and 21 periodontally healthy individuals were included. Whole-mouth and site-specific clinical periodontal parameters including probing depth, clinical attachment level, bleeding on probing, gingival index and plaque index were recorded. GCF and salivary HIF-1α, VEGF and TNF-α levels were measured by enzyme-linked immunosorbent assay. Statistical analysis was performed by using non-parametric tests.

Condition or disease
Periodontal Diseases

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Gingival Crevicular Fluid and Salivary HIF-1α, VEGF and TNF-α Levels in Different Periodontal Diseases
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : March 2, 2016
Actual Study Completion Date : December 26, 2016

Group/Cohort
Aggressive Periodontitis
These individuals had minimum PD ≥6 mm and CAL ≥5 mm on eight or more teeth; at least three of these were other than central incisors or first molars. Radiographic alveolar bone loss was ≥30% of root length affecting at least three permanent teeth other than first molars and incisors. The severe destruction pattern was not commensurate with amount of plaque accumulation.
Chronic periodontitis
These individuals had at least four non-adjacent teeth with sites with PD ≥6 mm and CAL ≥5 mm. They had also ≥50% alveolar bone loss in at least two quadrants that was commensurate with amount of plaque accumulation. BOP was >50% in the whole mouth.
Gingivitis
Gingivitis patients exhibited no sites with CAL >2 mm and no detectable alveolar bone loss in the radiography. BOP was >50% in the whole mouth.
Healthy
Periodontally healthy volunteers exhibited no sites with PD >3 mm and CAL >2 mm as well as no radiographic evidence of alveolar bone loss. BOP was <15% in the whole mouth.



Primary Outcome Measures :
  1. Gingival crevicular fluid HIF-1α levels [ Time Frame: A day after clinical periodontal examination ]
    pg


Secondary Outcome Measures :
  1. Salivary HIF-1α levels [ Time Frame: A day after clinical periodontal examination ]
    pg/ml

  2. Gingival crevicular fluid VEGF levels [ Time Frame: A day after clinical periodontal examination ]
    ng

  3. Salivary VEGF levels [ Time Frame: A day after clinical periodontal examination ]
    ng/l


Biospecimen Retention:   Samples Without DNA
Gingival crevicular fluid, saliva


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Ages Eligible for Study:   27 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All consecutive individuals were recruited from the Department of Periodontology, School of Dentistry, Adnan Menderes University, Aydın.
Criteria

Inclusion Criteria:

  1. Systemically healthy individuals
  2. Non-smoker individuals

Exclusion Criteria:

  1. Current pregnancy or lactation
  2. Nonsurgical/surgical periodontal treatment received for the past year
  3. Use of anti-inflammatory and antibiotic drugs within the past 6 months.

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Responsible Party: Beral Afacan, Assistant Professor, Adnan Menderes University
ClinicalTrials.gov Identifier: NCT03558906     History of Changes
Other Study ID Numbers: bafacan357
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

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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 Beral Afacan, Adnan Menderes University:
Periodontal disease
Hypoxia
Cytokines
Gingival crevicular fluid
Saliva

Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases