Running Title: PPAR-γ, RXR-α, and VDR Expressions in Periodontitis

PPAR-γ, RXR-α, and VDR Expressions in Periodontitis Patients With Different Stage and Grade Involvement

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.

Study Overview

• Status: Unknown
• Conditions: Periodontitis
• Intervention / Treatment: Diagnostic test: Gingiva Biopsy Sampling

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Ozkan KARATAS; Phone Number: 05335141032; Email: dtokaratas@hotmail.com

Study Locations

• Turkey
  • Tokat, Turkey, 60000
    • Gaziosmanpasa University
    • Contact: Özkan KARATAŞ; Phone Number: 5335141032; Email: dtokaratas@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability 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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group-1; Healthy individuals	Diagnostic test: Gingiva Biopsy Sampling; 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-2; Periodontitis patients-stage 3-grade B	Diagnostic test: Gingiva Biopsy Sampling; 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-3; Periodontitis patients-stage 3-grade C	Diagnostic test: Gingiva Biopsy Sampling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Periodontitis, PPAR-γ, RXR-α, VDR
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: Gaziosmanpasa University Per

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No