GCF Levels of IL-1β and IL-6 in Gingivitis and Stage III-Grade C Periodontitis

Sponsor
Uşak University (Other)
Overall Status
Completed
CT.gov ID
NCT04689438
Collaborator
(none)
64
1
2.7
24

Study Details

Study Description

Brief Summary

Periodontal diseases are chronic diseases that occur as a result of a violation of the balance between microbial dental plaque and the host response. Gingivitis is a disease characterized by inflammation of the gingiva that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gingiva along with gingivitis spreads to the periodontal ligament, alveolar bone and soft tissues that support the tooth, causing the destruction of these structures.2 Cytokines are low molecular weight proteins that participate in the initial and active stages of inflammation and immunity. In periodontal disease pathogenesis, cytokine response has been reported to play a very critical role in determining disease progression.3 IL-1beta and IL-6 are key cytokines in chronic inflammatory diseases and have the potential to initiate bone loss and tissue destruction seen in periodontal disease.4the purpose of this study; it is to determine the degree of inflammation and periodontal destruction by determining the levels of IL-1beta and IL-6 cytokines in the gingival crevicular fluid of periodontal healthy and diseased individuals.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: gingival crevicular fluid

Detailed Description

Plaque index (PI), gingival index (GI), presence of bleeding on probing (BOP), pocket depth (PD) and clinical attachment level (CAL) were used during the clinical periodontal assessment at 6 sites per tooth except third molar. All periodontal assessments were conducted with a manuel probe* by an experienced calibrated periodontist (AD). Calibration exercises were performed in 5 non-study periodontitis patients for probing depths (PD) and attachment loss (AL). The reproducibility of the parameters was verified via the kappa coefficient, which was 0.90 for PD and 0.88 for AL. After clinical evaluation, individuals were divided into 6 groups according to the 2017 World Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions (Chapple and Papapanou).

  1. Healthy control groups:

Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss.

  1. Gingivitis groups:

Consisted of individuals with a BOP score of 10% or greater and PD≤3mm with no attachment or radiographic bone loss.

  1. Stage III -Grade C periodontitis groups:

Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≤4. Rapid bone loss is observed compared to biofilm and % Root Bone Loss/age >1.0 is determined as grade C.

AL caused by root caries in the cervical region of the tooth, gingival recession caused by traumatic reasons, distal region of the second molar tooth due to extraction of the third molar, lesion in the marginal periodontium of endodontic origin, vertical root fracture were excluded from the study because they were not periodontal origin.

GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement. GCF was obtained using strips of filter paper† from the buccal part of an interproximal region in each quadrant. In the Periodontitis group, GCF was obtained from the regions where the most radiographic bone loss and SCD were observed. In these areas, if any, the plaque was slightly removed with sterile tools, and the area was isolated with cotton rolls. After drying the teeth with air, paper strips were placed in the gingival sulcus so that they remained there for 30 seconds. Strips contaminated with blood or saliva were removed from the study. The volume of absorbed GCF was determined by a calibrated electronic device (Periotron 8010, oraflow). The strips were then immediately transferred to sterile polypropylene tubes and frozen at -40°C for storage until analysis was carried out.The data obtained in this study will be analyzed using the SPSS 17 package program. Kolmogorov-Smirnov and Shapiro Wilk's tests will be used to investigate the states of variables coming from the normal distribution. 0.05 will be used as the level of significance when interpreting the results; if p<0.05, it will be stated that the variables do not adapt to the normal distribution, and if p>0.05, the variables adapt to the normal distribution. If the variables do not adapt to the normal distribution, nonparametric Kruskal Wallis-H tests will be used when examining the differences between the groups.

Study Design

Study Type:
Observational
Actual Enrollment :
64 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Usak University Faculty of Dentistry
Actual Study Start Date :
Oct 8, 2020
Actual Primary Completion Date :
Dec 25, 2020
Actual Study Completion Date :
Dec 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Healthy control groups

Consisted of individuals with clinically healthy gingiva on an intact periodontium who had a BOP score less than 10% and PD≤3mm, showed no attachment loss or radiographic bone loss.

Diagnostic Test: gingival crevicular fluid
GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.

Gingivitis groups

Consisted of individuals with a BOP score of 10% or greater and PD≤3mm with no attachment or radiographic bone loss.

Diagnostic Test: gingival crevicular fluid
GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.

Stage III -Grade C periodontitis groups

Consisted of individuals with interdental AL ≥5 mm, radiographic bone lose extending to middle or apical third of the root, PD≥6 mm and tooth loss due to periodontitis of ≤4. Rapid bone loss is observed compared to biofilm and % Root Bone Loss/age >1.0 is determined as grade C.

Diagnostic Test: gingival crevicular fluid
GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.

Outcome Measures

Primary Outcome Measures

  1. Measurement of IL-1Beta level in GCF [GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.]

    GCF was obtained using strips of filter paper† from the buccal part of an interproximal region.

  2. Measurement of IL-6 level in GCF [GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.]

    GCF was obtained using strips of filter paper† from the buccal part of an interproximal region.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Clinical diagnosis of periodontal diseases

  • Individuals must have 16 permanent teeth in their mouth

Exclusion Criteria:
  • Diabetes

  • İmmunological diseases

  • Pregnancy or lactation

  • Smokers

  • Individuals using antibiotics or anti-inflammatory drugs

  • Individuals receiving periodontal treatment in the last 6 months

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Usak Uşak Turkey 64200

Sponsors and Collaborators

  • Uşak University

Investigators

  • Principal Investigator: ahu dikilitaş, University of Usak
  • Study Chair: fatih karaaslan, University of Usak
  • Study Chair: abdullah seçkin ertuğrul, University of IZMIR KATİP CELEBİ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahu Dikilitaş, Usak University Faculty of Dentistry, Uşak University
ClinicalTrials.gov Identifier:
NCT04689438
Other Study ID Numbers:
  • UsakU7
First Posted:
Dec 30, 2020
Last Update Posted:
Dec 30, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahu Dikilitaş, Usak University Faculty of Dentistry, Uşak University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2020