- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03558906
TNF-α/HIF-1α/VEGF Pathway in Periodontal Diseases
Gingival Crevicular Fluid and Salivary HIF-1α, VEGF and TNF-α Levels in Different Periodontal Diseases
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Study Population and Clinical Examination
Eighty-seven participants were recruited for the study. Exclusion criteria were as follows: 1) systemic diseases that could affect the periodontium; 2) smoking; 3) current pregnancy or lactation; 4) nonsurgical/surgical periodontal treatment received for the past year; and 5) use of anti-inflammatory and antibiotic drugs within the past 6 months.
The full-mouth clinical periodontal examination included measurement of probing depth (PD), clinical attachment level (CAL), presence of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) at 6 sites per tooth. Presence and extent of alveolar bone loss were assessed radiographically. Based on clinical and radiographic diagnostic criteria proposed by 1999 International Workshop for a Classification of Periodontal Diseases and Conditions, the participants were categorized into four groups.
I. Generalized aggressive periodontitis (GAgP) group (n=20). 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 or other local risk factors for a given age.
II. Chronic periodontitis (CP) group (n=20). 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.
III. Gingivitis group (n=26). These individuals had varying degrees of gingival inflammation. They exhibited no sites with CAL >2 mm and no detectable alveolar bone loss in the radiography. BOP was >50% in the whole mouth.
IV. Healthy group (n=21). These 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.
Saliva sampling
Whole unstimulated saliva samples were collected. Each participant was asked first to rinse the mouth completely with tap water for 2 minutes, wait for 10 minutes, and then expectorate into sterile polypropylene tube for 5 minutes.
Gingival crevicular fluid (GCF) sampling
Standardized filter paper strips were used for GCF sampling. Two GCF samples were taken from the buccal aspects of two non-adjacent interproximal sites of each individual. In patients with periodontitis, GCF were sampled from two sites exhibiting PD ≥6 mm and CAL ≥5 mm. GCF samples of gingivitis patients were obtained from the sites that exhibit BOP but no clinical attachment loss. In the healthy group, GCF samples were collected the sites exhibiting PD <3 mm without BOP and clinical attachment loss.
Measurement of hypoxia inducible factor-1 alpha (HIF-1α), vascular endothelial growth factor (VEGF) and tumor necrosis factor-alpha (TNF-α) Levels in GCF and Saliva Samples
HIF-1α, VEGF and TNF-α levels in GCF and saliva samples were measured by the enzyme-linked immunosorbent assay (ELISA) using commercial kits according to the manufacturer's guidelines.
Statistical Analysis
All data analyses were performed using a statistical software package. Comparisons of clinical and biochemical parameters between the study groups were performed using the Kruskal-Wallis test.
Tipo di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Systemically healthy individuals
- Non-smoker individuals
Exclusion Criteria:
- Current pregnancy or lactation
- Nonsurgical/surgical periodontal treatment received for the past year
- Use of anti-inflammatory and antibiotic drugs within the past 6 months.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Trasversale
Coorti e interventi
Gruppo / Coorte |
---|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Gingival crevicular fluid HIF-1α levels
Lasso di tempo: A day after clinical periodontal examination
|
pg
|
A day after clinical periodontal examination
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Salivary HIF-1α levels
Lasso di tempo: A day after clinical periodontal examination
|
pg/ml
|
A day after clinical periodontal examination
|
Gingival crevicular fluid VEGF levels
Lasso di tempo: A day after clinical periodontal examination
|
ng
|
A day after clinical periodontal examination
|
Salivary VEGF levels
Lasso di tempo: A day after clinical periodontal examination
|
ng/l
|
A day after clinical periodontal examination
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
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