PeriodontitisNCT04020146

PPAR, RXR, and VDR Expressions in Peri-implantitis

An observational study of Periodontitis and Periimplantitis, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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)… Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Periodontitis, Periimplantitis
What is being tested?: Gingival biopsies
How many people: 45 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 10 Jan 2018to 10 Mar 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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).

Who may be able to join

healthy individuals
periodontitis patients
periimplantitis patients

Who cannot join

smokers,
systemically compromised patients

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Gaziosmanpasa University
Tokat Province, 60100

Other trials in Turkey (Türkiye)

About this study

Official title: PPAR-γ, RXR, and VDR Expressions in Gingival Tissue Samples of Healthy Individuals, Periodontitis and Peri-implantitis Patients

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.

Conditions: Periodontitis, Periimplantitis
Being tested: Gingival biopsies
Keywords: periodontitis, periimplantitis, RXR, VDR
Medical subject headings: Periodontitis, Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04020146
Study group	Role	What they receive
group 1;		healthy controls (C, n=15), Receives: Other: Gingival biopsies
group 2		periodontitis patients with stage 3 grade B; (P, n=15) Receives: Other: Gingival biopsies
group 3		peri-implantitis patients (PI, n=15). Receives: Other: Gingival biopsies

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 201810 Mar 2019

First posted15 Jul 2019
Study start10 Jan 2018
Primary completion10 Jan 2019
Study completion10 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PeriodontitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04020146
Sponsor's protocol ID: Gaziosmanpasa University
Status last verified: Jul 2019
First submitted: 8 Jul 2019
Last updated: 15 Jul 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PPAR-γ, RXR, and VDR Expressions in Gingival Tissue Samples of Healthy Individuals, Periodontitis and Peri-implantitis Patients
ClinicalTrials.gov ID: NCT04020146
Acronym / sponsor ID: Gaziosmanpasa University
Conditions: Periodontitis, Periimplantitis
Keywords: periodontitis, periimplantitis, RXR, VDR
Study type: Observational
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Tokat Gaziosmanpasa UniversityUniversity, hospital or other
Study start: 10 Jan 2018 (actual)
Primary completion: 10 Jan 2019 (actual)
Study completion: 10 Mar 2019 (actual)
First posted: 15 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 3

Arm	Type	Receives
group 1;	–	Other: Gingival biopsieshealthy controls (C, n=15),
group 2	–	Other: Gingival biopsiesperiodontitis patients with stage 3 grade B; (P, n=15)
group 3	–	Other: Gingival biopsiesperi-implantitis patients (PI, n=15).

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
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).

Key inclusion criteria (3 listed)

healthy individuals
periodontitis patients
periimplantitis patients

Key exclusion criteria (2 listed)

smokers,
systemically compromised patients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gingival biopsiesGingival biopsies were obtained from all participants and biopsy samples underwent histological tissue processing.	Other	group 1;, group 2, group 3

Primary outcome

Inflammatory cells counts
Time frame: 6 months
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.
Fibroblast counts
Time frame: 6 months
Fibroblasts counts were evaluated from H\&E stained slides under 1000x magnification via a light microscope (Nikon Eclipse, E 600, Tokyo, Japan).
Peroxisome proliferative-activated receptor (PPAR)-γ
Time frame: During histological processing
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).
Retinoid X receptor (RXR)-α
Time frame: 6 months
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).
Vitamin D receptor (VDR)
Time frame: 6 months
. 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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
Individual participant dataSharing planned: No

Related trials for Periodontitis

Active, not recruitingObservational study
Antibiotic Resistance Genes in Periodontitis
Periodontal Disease, Periodontitis
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Recruiting
A Closed Surgical Technique vs Modified Papilla Preservation Technique
Intrabony Periodontal Defect, Treatment
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
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RecruitingObservational study
Candida Albicans in Syrian Patients With Periodontitis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis and Periimplantitis, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammatory cells counts (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04020146.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.