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GCF HIF-1α, VEGF and TNF-α Levels in G-AgP Patients Before and After Periodontal Treatment.

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ClinicalTrials.gov Identifier: NCT04020315
Recruitment Status : Completed
First Posted : July 16, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Beral Afacan, Aydin Adnan Menderes University

Brief Summary:
Hypoxia-inducible angiogenic pathway involving hypoxia inducible factor-1 alpha (HIF-1α), vascular endothelial growth factor (VEGF) and tumour necrosis factor- alpha (TNF-α) may regulate the several biological processes related to inflammation. Generalized aggressive periodontitis (G-AgP) is a rare but highly destructive form of inflammatory periodontal disease. The present study aimed to assess the effect of non-surgical periodontal treatment on gingival crevicular fluid (GCF) HIF-1α, VEGF and TNF-α levels in G-AgP patients. 20 G-AgP and 20 periodontally healthy subjects were enrolled. At baseline, GCF samples were collected and whole mouth clinical periodontal parameters were recorded. G-AgP patients received non-surgical periodontal treatment. Clinical parameters and GCF cytokines were re-measured at 1 and 3 months after treatment. GCF HIF-1α, VEGF and TNF-α levels were analyzed by ELISA. Data were analyzed using appropriate statistical tests.

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis, Generalized Periodontal Health Procedure: Non-surgically performed scaling and root planing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Non-surgical Periodontal Treatment on GCF HIF-1α, VEGF and TNF-α Levels in Generalized Aggressive Periodontitis Patients.
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : September 15, 2018

Arm Intervention/treatment
Experimental: Generalized aggressive periodontitis
Non-surgically performed scaling and root planing.
Procedure: Non-surgically performed scaling and root planing
Non-surgically performed scaling and root planing




Primary Outcome Measures :
  1. Gingival crevicular fluid protein content change [ Time Frame: Change from baseline to 1 month and 3 months after treatment ]
    pg/ml



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. aged 25 to 45 years
  2. non-smokers with no history of smoking
  3. having at least 20 natural teeth.

Exclusion Criteria:

  1. having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological and mucocutaneous diseases
  2. usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months
  3. having any non-inflammatory destructive periodontal disease
  4. nonsurgical/surgical periodontal therapy received in the past year
  5. having a restorative and endodontic treatment requirement
  6. having orthodontic appliances or a removable partial denture
  7. pregnant/ lactating/ postmenopausal females.

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): NCT04020315


Locations
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Turkey
Adnan Menderes University, Faculty of Dentistry, Department of Periodontology
Aydın, Turkey, 09100
Sponsors and Collaborators
Aydin Adnan Menderes University
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Responsible Party: Beral Afacan, Principal Investigator, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT04020315    
Other Study ID Numbers: AggressiveHIF
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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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, Aydin Adnan Menderes University:
aggressive periodontitis
gingival crevicular fluid
hypoxia
cytokines
Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms