- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
---|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Gingival crevicular fluid HIF-1α levels
Tidsramme: A day after clinical periodontal examination
|
pg
|
A day after clinical periodontal examination
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Salivary HIF-1α levels
Tidsramme: A day after clinical periodontal examination
|
pg/ml
|
A day after clinical periodontal examination
|
Gingival crevicular fluid VEGF levels
Tidsramme: A day after clinical periodontal examination
|
ng
|
A day after clinical periodontal examination
|
Salivary VEGF levels
Tidsramme: A day after clinical periodontal examination
|
ng/l
|
A day after clinical periodontal examination
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
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