PeriodontitisNCT04689438
GCF Levels of IL-1β and IL-6 in Gingivitis and Stage III-Grade C Periodontitis
An observational study of Periodontitis, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
Periodontal diseases are chronic diseases that occur as a result of a violation of the balance between microbial dental plaque and the host response. Gingivitis is a disease characterized by inflammation of the gingiva that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- gingival crevicular fluid
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Oct 2020to 28 Dec 2020
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: individuals who have periodontal disease will be selected
Who may be able to join
- have periodontitis
- have 16 permanent teeth
Who cannot join
- Systemic disease
- using drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usak University Faculty of Dentistry
Periodontal diseases are chronic diseases that occur as a result of a violation of the balance between microbial dental plaque and the host response. Gingivitis is a disease characterized by inflammation of the gingiva that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gingiva along with gingivitis spreads to the periodontal ligament, alveolar bone and soft tissues that support the tooth, causing the destruction of these structures.2 Cytokines are low molecular weight proteins that participate in the initial and active stages of inflammation and immunity. In periodontal disease pathogenesis, cytokine response has been reported to play a very critical role in determining disease progression.3 IL-1beta and IL-6 are key cytokines in chronic inflammatory diseases and have the potential to initiate bone loss and tissue destruction seen in periodontal disease.4the purpose of this study; it is to determine the degree of inflammation and periodontal destruction by determining the levels of IL-1beta and IL-6 cytokines in the gingival crevicular fluid of periodontal healthy and diseased individuals.
Read the detailed description
Periodontal measurement were done at 6 sites per tooth After clinical evaluation, individuals were divided into 3 groups
- Healthy control groups: clinically healthy gingiva
- Gingivitis groups: BOP score of 10% or greater and PD≤3mm
- Periodontitis groups:
AL ≥5 mm, PD≥6 mm and tooth loss due to periodontitis of ≤4. GCF samples were collected using strips.
- Conditions
- Periodontitis
- Being tested
- gingival crevicular fluid
- Keywords
- periodontal disease, periodontitis, gingivitis, cytokines
- Medical subject headings
- Periodontitis, Periodontal Diseases, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gingival crevicular fluidDiagnostic test
GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control groups | clinically healthy gingiva BOP score less than 10% Receives: Diagnostic Test: gingival crevicular fluid | |
| Gingivitis groups | BOP score of 10% or greater Receives: Diagnostic Test: gingival crevicular fluid | |
| Periodontitis groups | interdental AL ≥5 mm, PD≥6 mm Receives: Diagnostic Test: gingival crevicular fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of IL-1Beta level
GCF was taken interproximal region.
Measured: GCF was taken within 1 week after clinical examination
Measurement of IL-6 level in GCF
GCF was taken interproximal region.
Measured: GCF was taken within 1 week after clinical examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start8 Oct 2020
- Primary completion25 Dec 2020
- Study completion28 Dec 2020
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
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahu Dikilitaş, Uşak University
- Investigators
- ahu dikilitaş, Principal investigator, University of Usakfatih karaaslan, Study chair, University of Usakabdullah seçkin ertuğrul, Study chair, University of IZMIR KATİP CELEBİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689438
- Sponsor's protocol ID
- UsakU7
- Status last verified
- Nov 2022
- First submitted
- 28 Dec 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usak University Faculty of Dentistry
- ClinicalTrials.gov ID
- NCT04689438
- Acronym / sponsor ID
- UsakU7
- Conditions
- Periodontitis
- Keywords
- periodontal disease, periodontitis, gingivitis, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 30 Dec 2020 (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.
Periodontal diseases are chronic diseases that occur as a result of a violation of the balance between microbial dental plaque and the host response. Gingivitis is a disease characterized by inflammation of the gingiva that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gingiva along with gingivitis spreads to the periodontal ligament, alveolar bone and soft tissues that support the tooth, causing the destruction of these structures.2 Cytokines are low molecular weight proteins that participate in the initial and active stages of inflammation and immunity. In periodontal disease pathogenesis, cytokine response has been reported to play a very critical role in determining disease progression.3 IL-1beta and IL-6 are key cytokines in chronic inflammatory diseases and have the potential to initiate bone loss and tissue destruction seen in periodontal disease.4the purpose of this study; it is to determine the degree of inflammation and periodontal destruction by determining the levels of IL-1beta and IL-6 cytokines in the gingival crevicular fluid of periodontal healthy and diseased individuals.
Detailed description
Periodontal measurement were done at 6 sites per tooth After clinical evaluation, individuals were divided into 3 groups
- Healthy control groups: clinically healthy gingiva
- Gingivitis groups: BOP score of 10% or greater and PD≤3mm
- Periodontitis groups:
AL ≥5 mm, PD≥6 mm and tooth loss due to periodontitis of ≤4. GCF samples were collected using strips.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control groups | – | Diagnostic Test: gingival crevicular fluidclinically healthy gingiva BOP score less than 10% |
| Gingivitis groups | – | Diagnostic Test: gingival crevicular fluidBOP score of 10% or greater |
| Periodontitis groups | – | Diagnostic Test: gingival crevicular fluidinterdental AL ≥5 mm, PD≥6 mm |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals who have periodontal disease will be selected
Key inclusion criteria (2 listed)
- have periodontitis
- have 16 permanent teeth
Key exclusion criteria (2 listed)
- Systemic disease
- using drugs
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 crevicular fluidGCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement. | Diagnostic test | Gingivitis groups, Healthy control groups, Periodontitis groups |
Primary outcome
Measurement of IL-1Beta level
Time frame: GCF was taken within 1 week after clinical examination
GCF was taken interproximal region.
Measurement of IL-6 level in GCF
Time frame: GCF was taken within 1 week after clinical examination
GCF was taken interproximal region.
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 4 Nov 2022.
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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.
ahu dikilitaş principal investigator
University of Usak
fatih karaaslan study chair
University of Usak
abdullah seçkin ertuğrul study chair
University of IZMIR KATİP CELEBİ
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 Uşak 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 2 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 4 Nov 2022. 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?
Measurement of IL-1Beta level (time frame: GCF was taken within 1 week after clinical examination). The study lists 2 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 4 Nov 2022.