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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05325905
Other study ID # 2014/01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date January 2017

Study information

Verified date April 2022
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.


Description:

Gingival crevicular fluid (GCF) is formed when fluid exudes from the vessels of the microcirculation into the inflamed periodontal tissue and into the sulcus or pocket. As the fluid traverses the inflamed tissue, it is thought to pick up enzymes and other molecules that participate in the destructive process, as well as products of cell and tissue degradation. Efforts to develop diagnostic tests based on host factors have been focused almost entirely on analysis of GCF. The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status. Systemically healthy and non-smokers 80 participants (30 males and 50 females) who were selected from among admitting to Dentistry Faculty of Selcuk University were included in this study. Clinical periodontal parameters were recorded and GCF samples were obtained. Samples were stored in -80 ˚C until analysis with Enzyme-Linked ImmunoSorbent Assay (ELISA).


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date January 2017
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Systemically healthy - non-smokers, - presence of at least 20 teeth in the mouth Exclusion Criteria: - receiving periodontal therapy in the last 6 months; - receiving antibiotics or anti-inflammatory drugs in the last 6 months; - currently pregnant or breastfeeding - using a removable partial denture and removable or fixed orthodontic appliances.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Gingival crevicular fluid sampling
GCF sampling and clinical periodontal measurements were performed

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Bezmialem Vakif University Selcuk University

Outcome

Type Measure Description Time frame Safety issue
Primary Interleukin-36? (IL-36?) levels in GCF GCF samples were obtained from one interproximal site in each quadrant Baseline
Secondary Probing depth (PD) PD; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars. Baseline
Secondary Clinical attachment level (CAL) CAL; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars. Baseline
Secondary Bleeding on Probing (BoP) BoP, from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars Baseline
Secondary IL-10 and IL-1ß levels in GCF GCF samples were obtained from one interproximal site in each quadrant Baseline
Secondary Plaque Index (PI) PI; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars Baseline
Secondary Gingival Index (GI) GI; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars Baseline
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