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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04018144
• Other study ID #: Gaziosmanpasa University Per
• Status: Not yet recruiting
• Start date: August 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: July 2019
• Source: Tokat Gaziosmanpasa University
• Contact: Ozkan KARATAS
• Phone: 05335141032
• Email: dtokaratas[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: March 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	PPAR (Peroxisome proliferative activator receptor)-?	PPAR (Peroxisome proliferative activator receptor)-? levels were determined via immunohistochemistry.	During histological tissue processing
Primary	RXR (Retinoid X receptor)-a	RXR (Retinoid X receptor)-a levels were determined via immunohistochemistry.	During histological tissue processing
Primary	Vitamin D receptor (VDR)	Vitamin D receptor (VDR) levels were determined via immunohistochemistry.	During histological tissue processing