NCT04020146

Brief Summary

ABSTRACT Objective: Periodontitis and peri-implantitis are the irreversible destructive diseases of the periodontal and peri-implant tissues. The present study aimed to determine the receptor expressions of Peroxisome proliferative-activated receptor (PPAR)-γ, Retinoid X receptor (RXR)-α, and Vitamin D receptor (VDR) in the diseased tissues around teeth and dental implants. Methods: The study consisted of three groups as group 1; healthy controls (C, n=15), group 2; periodontitis patients with stage 3 grade B (P, n=15), and group 3; peri-implantitis patients (PI, n=15). Periodontal clinical parameters as the plaque index (PI), gingival index (GI) and clinical attachment levels (CAL) were recorded. Gingival biopsies were obtained from all participants and biopsy samples underwent histological tissue processing. Hematoxylin-eosin (H\&E) and immunohistochemistry staining were performed. Total inflammatory cell counts and fibroblast cell density were evaluated on H\&E-stained slides while PPAR-γ, RXR-α, and VDR were evaluated via immunohistochemistry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 8, 2019

Last Update Submit

July 12, 2019

Conditions

Keywords

periodontitisperiimplantitisRXRVDR

Outcome Measures

Primary Outcomes (5)

  • Inflammatory cells counts

    Gingival biopsies were obtained from all participants and biopsy samples underwent histological tissue processing. Hematoxylin-eosin (H\&E) staining were performed. Total inflammatory cell counts density were evaluated on H\&E-stained slides.A cell counting frame of 10.000 µm2 area was selected under 1000x magnification. The total inflammatory cells (neutrophil, lymphocyte, eosinophil, and macrophage cells) within the frame were counted as inflammatory cell counting.

    6 months

  • Fibroblast counts

    Fibroblasts counts were evaluated from H\&E stained slides under 1000x magnification via a light microscope (Nikon Eclipse, E 600, Tokyo, Japan).

    6 months

  • Peroxisome proliferative-activated receptor (PPAR)-γ

    Gingival biopsies were obtained from all participants and biopsy samples underwent histological tissue processin and immunohistochemistry staining were performed, PPAR-γ, was evaluated via immunohistochemistry. Samples were examined under 400x magnification using light microscopy (Nikon Eclipse, E 600, Tokyo, Japan).

    During histological processing

  • Retinoid X receptor (RXR)-α

    Gingival biopsies were obtained from all participants and biopsy samples underwent histological tissue processing and immunohistochemistry staining were performed, RXR-α was evaluated via immunohistochemistry. Samples were examined under 400x magnification using light microscopy (Nikon Eclipse, E 600, Tokyo, Japan).

    6 months

  • Vitamin D receptor (VDR)

    . Gingival biopsies were obtained from all participants and biopsy samples underwent histological tissue processing and immunohistochemistry staining were performed, VDR was evaluated via immunohistochemistry. Samples were examined under 400x magnification using light microscopy (Nikon Eclipse, E 600, Tokyo, Japan).

    6 months

Study Arms (3)

group 1;

healthy controls (C, n=15),

Other: Gingival biopsies

group 2

periodontitis patients with stage 3 grade B; (P, n=15)

Other: Gingival biopsies

group 3

peri-implantitis patients (PI, n=15).

Other: Gingival biopsies

Interventions

Gingival biopsies were obtained from all participants and biopsy samples underwent histological tissue processing.

group 1;group 2group 3

Eligibility Criteria

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

The study consisted of three groups as group 1; healthy controls (C, n=15), group 2; periodontitis patients with stage 3 grade B (P, n=15), and group 3; peri-implantitis patients (PI, n=15).

You may qualify if:

  • healthy individuals
  • periodontitis patients
  • periimplantitis patients

You may not qualify if:

  • smokers,
  • systemically compromised patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PeriodontitisPeri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

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

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 15, 2019

Study Start

January 10, 2018

Primary Completion

January 10, 2019

Study Completion

March 10, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations