GCF HIF-1α, VEGF and TNF-α Levels in G-AgP Patients Before and After Periodontal Treatment.
Effect of Non-surgical Periodontal Treatment on GCF HIF-1α, VEGF and TNF-α Levels in Generalized Aggressive Periodontitis Patients.
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2018
CompletedFirst Submitted
Initial submission to the registry
July 12, 2019
CompletedFirst Posted
Study publicly available on registry
July 16, 2019
CompletedJuly 17, 2019
July 1, 2019
9 months
July 12, 2019
July 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gingival crevicular fluid protein content change
pg/ml
Change from baseline to 1 month and 3 months after treatment
Study Arms (1)
Generalized aggressive periodontitis
EXPERIMENTALNon-surgically performed scaling and root planing.
Interventions
Non-surgically performed scaling and root planing
Eligibility Criteria
You may qualify if:
- aged 25 to 45 years
- non-smokers with no history of smoking
- having at least 20 natural teeth.
You may not qualify if:
- having any diagnosed medical disorders such as diabetes mellitus, cardiovascular diseases, rheumatoid arthritis, immunological and mucocutaneous diseases
- usage of antibiotics, non-steroidal anti-inflammatory drugs and immunosuppressive agents within the past 6 months
- having any non-inflammatory destructive periodontal disease
- nonsurgical/surgical periodontal therapy received in the past year
- having a restorative and endodontic treatment requirement
- having orthodontic appliances or a removable partial denture
- pregnant/ lactating/ postmenopausal females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adnan Menderes University, Faculty of Dentistry, Department of Periodontology
Aydin, 09100, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 12, 2019
First Posted
July 16, 2019
Study Start
December 1, 2017
Primary Completion
August 30, 2018
Study Completion
September 15, 2018
Last Updated
July 17, 2019
Record last verified: 2019-07