NCT04018144

Brief Summary

Objective: The present study aimed to determine the expressions of nuclear receptors PPAR (Peroxisome proliferative activator receptor)-γ, RXR (Retinoid X receptor)-α, and vitamin D receptor (VDR) in healthy volunteers and periodontitis patients with different grade involvement. Methods: Group-1; healthy individuals, Group-2; periodontitis patients-stage 3 grade B, (H-GradeB), Group-3; periodontitis patients-stage 3 grade C, (D-GradeC). Clinical parameters as plaque index (PI), gingival index (GI) and clinical attachment levels (CAL) were measured. Fibroblast and inflammatory cells, PPAR-γ, RXR-α, and VDR levels were determined in histological slides.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 10, 2019

Last Update Submit

July 10, 2019

Conditions

Periodontitis

Keywords

Periodontitis, PPAR-γ, RXR-α, VDR

Outcome Measures

Primary Outcomes (5)

  • Inflammatory cell counts

    Connective tissues were evaluated, and inflammatory cell infiltration were counted in the H\&E stained slides using a light microscope (Nikon Eclipse, E 600, Tokyo, Japan). For cell counting, connective tissue neighboring gingival epithelium was marked, and a cell counting frame of 10000 µm2 was marked. Inflammatory cells (neutrophil, lymphocyte, eosinophil, and macrophage cells) within the frame were counted. The measurements were performed from three different points, and the mean of these three measurements was recorded.

    During histological tissue processing

  • Fibroblasts counts

    For cell counting, connective tissue neighboring gingival epithelium was marked, and a cell counting frame of 10000 µm2 was marked. The fibroblast counts within the frame were counted. The measurements were performed from three different points, and the mean of these three measurements was recorded.

    During histological tissue processing

  • PPAR (Peroxisome proliferative activator receptor)-γ

    PPAR (Peroxisome proliferative activator receptor)-γ levels were determined via immunohistochemistry.

    During histological tissue processing

  • RXR (Retinoid X receptor)-α

    RXR (Retinoid X receptor)-α levels were determined via immunohistochemistry.

    During histological tissue processing

  • Vitamin D receptor (VDR)

    Vitamin D receptor (VDR) levels were determined via immunohistochemistry.

    During histological tissue processing

Study Arms (3)

Group-1

Healthy individuals

Diagnostic Test: Gingiva Biopsy Sampling

Group-2

Periodontitis patients-stage 3-grade B

Diagnostic Test: Gingiva Biopsy Sampling

Group-3

Periodontitis patients-stage 3-grade C

Diagnostic Test: Gingiva Biopsy Sampling

Interventions

Gingiva Biopsy SamplingDIAGNOSTIC_TEST

Gingival samples of healthy individuals were collected by gingivectomy or crown lengthening procedure in the routine treatment protocol or before orthodontically indicated tooth extraction. Gingival samples of periodontitis patients were obtained during the scaling and root planning procedure. Posterior maxillary teeth (#4, #5, #6, and #7) were chosen for gingival sampling.

Group-1Group-2Group-3

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Three study groups were created, and 45 participants were enrolled in the present study. The study groups were; Group-1; healthy individuals (mean age 42.34±3.89, nine women, six men) Group-2; periodontitis patients-stage 3 grade B, (GradeB) (mean age 43.12±3.16, 10 women, 5 men) Group-3; periodontitis patients-stage 3 grade C, (GradeC) (mean age 42.78±2.99, 10 women, 5 men)

You may qualify if:

  • systemic health
  • no drug use
  • no previous periodontal treatment within six months
  • no tobacco use

You may not qualify if:

  • pregnant or lactating women
  • patients used antibiotics in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Ozkan KARATAS

CONTACT

05335141032dtokaratas@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 12, 2019

Study Start

August 1, 2019

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)