PeriodontitisNCT04629313
GCF Levels of IL-1Beta, MIP-1 Alfa and G-CSF in Gingivitis and Stage I-II-III-IV Periodontitis Patients
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 gums that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 30 Oct 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
- Clinical diagnosis of periodontal diseases
- Individuals must have 16 permanent teeth in their mouth
Who cannot join
- Diabetes
- İmmunological diseases
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 gums that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gum 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, MIP-1alfa and G-CSF 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, MIP-1alfa, G-CSF cytokines in the gum groove fluid of periodontal healthy and diseased individuals.
Read the detailed description
Plaque index (PI), gingival index (GI), presence of bleeding on probing (BOP), pocket depth (PD) and clinical attachment level (CAL) were used After clinical evaluation, individuals were divided into 6 groups Healthy control groups, gingivitis groups, Stage I groups, Stage II groups, Stage III groups and Stage IV groups GCF samples were collected after clinical periodontal measurement. GCF was obtained using strips of filter paper Kolmogorov-Smirnov and Shapiro Wilk's tests used
- Conditions
- Periodontitis
- Keywords
- periodontal disease, periodontitis, cytokines
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| periodontal disease group | Gingivitis: BOP score of 10% or greater and PD≤3mm with no attachment or radiographic bone loss. SI Periodontitis: interdental AL of 1-2 mm, PD≤4 mm and no tooth loss SII Periodontitis: interdental AL of 3-4 mm, PD≤5 mm and no tooth loss SIII Periodontitis: interdental AL ≥5 mm, PD≥6 mm SIV Periodontitis: interdental AL ≥5 mm teeth, radiographic bone lose extending to middle or apical third of the root, | |
| periodontal healthy group | consisted of individuals with clinically healthy gingiva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of IL-1Beta, G-CSF, MIP-1alfa levels in GCF
Measurement of GCF samples
Measured: GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement. GCF was obtained using strips of filter paper† from the buccal part of an interproximal region.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Jul 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 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
- 120 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 Usakumut yiğit, Study chair, University of Usakesra özge aydın, Study chair, University of UsakAbdullah seçkin ertuğrul, Study director, University of Usak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629313
- Sponsor's protocol ID
- UsakU6
- Status last verified
- Sep 2021
- First submitted
- 9 Nov 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usak University Faculty of Dentistry
- ClinicalTrials.gov ID
- NCT04629313
- Acronym / sponsor ID
- UsakU6
- Conditions
- Periodontitis
- Keywords
- periodontal disease, periodontitis, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 16 Nov 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 gums that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gum 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, MIP-1alfa and G-CSF 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, MIP-1alfa, G-CSF cytokines in the gum groove fluid of periodontal healthy and diseased individuals.
Detailed description
Plaque index (PI), gingival index (GI), presence of bleeding on probing (BOP), pocket depth (PD) and clinical attachment level (CAL) were used After clinical evaluation, individuals were divided into 6 groups Healthy control groups, gingivitis groups, Stage I groups, Stage II groups, Stage III groups and Stage IV groups GCF samples were collected after clinical periodontal measurement. GCF was obtained using strips of filter paper Kolmogorov-Smirnov and Shapiro Wilk's tests used
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| periodontal disease group | – | –Gingivitis: BOP score of 10% or greater and PD≤3mm with no attachment or radiographic bone loss. SI Periodontitis: interdental AL of 1-2 mm, PD≤4 mm and no tooth loss SII Periodontitis: interdental AL of 3-4 mm, PD≤5 mm and no tooth loss SIII Periodontitis: interdental AL ≥5 mm, PD≥6 mm SIV Periodontitis: interdental AL ≥5 mm teeth, radiographic bone lose extending to middle or apical third of the root, |
| periodontal healthy group | – | –consisted of individuals with clinically healthy gingiva |
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)
- Clinical diagnosis of periodontal diseases
- Individuals must have 16 permanent teeth in their mouth
Key exclusion criteria (2 listed)
- Diabetes
- İmmunological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of IL-1Beta, G-CSF, MIP-1alfa levels in GCF
Time frame: GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement. GCF was obtained using strips of filter paper† from the buccal part of an interproximal region.
Measurement of GCF samples
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 5 Oct 2021.
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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
umut yiğit study chair
University of Usak
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 5 Oct 2021. 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, G-CSF, MIP-1alfa levels in GCF (time frame: GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement. GCF was obtained using strips of filter paper† from the buccal part of an interproximal region.). 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 5 Oct 2021.