PeriodontitisNCT04018144
Running Title: PPAR-γ, RXR-α, and VDR Expressions in Periodontitis
An observational study of Periodontitis, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Gingiva Biopsy Sampling
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 1 Mar 2020
- How long will I take part?
- 6 Months
- 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: 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)
Who may be able to join
- systemic health
- no drug use
- no previous periodontal treatment within six months
- no tobacco use
Who cannot join
- pregnant or lactating women
- patients used antibiotics in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60000
Özkan KARATAŞ, 5335141032, dtokaratas@hotmail.com
About this study
Official title: 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.
- Conditions
- Periodontitis
- Being tested
- Gingiva Biopsy Sampling
- Keywords
- Periodontitis, PPAR-γ, RXR-α, VDR
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingiva Biopsy SamplingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group-1 | Healthy individuals Receives: Diagnostic Test: Gingiva Biopsy Sampling | |
| Group-2 | Periodontitis patients-stage 3-grade B Receives: Diagnostic Test: Gingiva Biopsy Sampling | |
| Group-3 | Periodontitis patients-stage 3-grade C Receives: Diagnostic Test: Gingiva Biopsy Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During histological tissue processing
PPAR (Peroxisome proliferative activator receptor)-γ
PPAR (Peroxisome proliferative activator receptor)-γ levels were determined via immunohistochemistry.
Measured: During histological tissue processing
RXR (Retinoid X receptor)-α
RXR (Retinoid X receptor)-α levels were determined via immunohistochemistry.
Measured: During histological tissue processing
Vitamin D receptor (VDR)
Vitamin D receptor (VDR) levels were determined via immunohistochemistry.
Measured: During histological tissue processing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
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 (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özkan Karataş, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018144
- Sponsor's protocol ID
- Gaziosmanpasa University Per
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- 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 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPAR-γ, RXR-α, and VDR Expressions in Periodontitis Patients With Different Stage and Grade Involvement
- ClinicalTrials.gov ID
- NCT04018144
- Acronym / sponsor ID
- Gaziosmanpasa University Per
- Conditions
- Periodontitis
- Keywords
- Periodontitis, PPAR-γ, RXR-α, VDR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 12 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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group-1 | – | Diagnostic Test: Gingiva Biopsy SamplingHealthy individuals |
| Group-2 | – | Diagnostic Test: Gingiva Biopsy SamplingPeriodontitis patients-stage 3-grade B |
| Group-3 | – | Diagnostic Test: Gingiva Biopsy SamplingPeriodontitis patients-stage 3-grade C |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- systemic health
- no drug use
- no previous periodontal treatment within six months
- no tobacco use
Key exclusion criteria (2 listed)
- pregnant or lactating women
- patients used antibiotics in the last 6 months
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 |
|---|---|---|
| Gingiva Biopsy SamplingGingival 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. | Diagnostic test | Group-1, Group-2, Group-3 |
Primary outcome
Inflammatory cell counts
Time frame: During histological tissue processing
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.
Fibroblasts counts
Time frame: During histological tissue processing
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.
PPAR (Peroxisome proliferative activator receptor)-γ
Time frame: During histological tissue processing
PPAR (Peroxisome proliferative activator receptor)-γ levels were determined via immunohistochemistry.
RXR (Retinoid X receptor)-α
Time frame: During histological tissue processing
RXR (Retinoid X receptor)-α levels were determined via immunohistochemistry.
Vitamin D receptor (VDR)
Time frame: During histological tissue processing
Vitamin D receptor (VDR) levels were determined via immunohistochemistry.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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.
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, 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 4 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: status not confirmed, as of the sponsor's last update on 12 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozkan KARATAS (05335141032, dtokaratas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory cell counts (time frame: During histological tissue processing). 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 12 Jul 2019.