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).
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
About this study
Official title: PPAR-γ, RXR, and VDR Expressions in Gingival Tissue Samples of Healthy Individuals, Periodontitis and Peri-implantitis Patients
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mehmet murat taskan, Tokat Gaziosmanpasa University
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
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.
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.
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
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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?
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.