PeriodontitisNCT04891627
Gingival Crevicular IL-34 and CSF-1 Levels in Patients With Periodontitis and Uncontrolled Type 2 Diabetes
An observational study of Periodontitis and Diabetes, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
Type 2 diabetes mellitus is a metabolic disorder. There is a bidirectional association between periodontal disease and DM. Currently there is no data relationship between CSF-1 and IL-34, periodontal disease and diabetes.The aim of this study to investigate GCF levels of IL-34 and CSF-1 in periodontitis subjects with… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Diabetes
- What is being tested?
- Gingival crevicular fluid
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2021to 4 May 2021
- How long will I take part?
- 3 Weeks
- 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 have diabetes and periodontitis
Who may be able to join
- have 20 teeth
- have diabetes .
Who cannot join
- Individuals have systemic disease
- smokers;
- pregnant
- those using drugs;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usak University Faculty of Dentistry
Type 2 diabetes mellitus is a metabolic disorder. There is a bidirectional association between periodontal disease and DM. Currently there is no data relationship between CSF-1 and IL-34, periodontal disease and diabetes.The aim of this study to investigate GCF levels of IL-34 and CSF-1 in periodontitis subjects with diabetes.
Read the detailed description
Periodontally healthy (H), periodontitis, and periodontitis with diabetes patients, were recruited for this study.
- Inclusion criteria for H groups: Individuals with clinically healthy gingiva, no attachment and bone loss, and less than 10% bleeding on probing were included.
- Inclusion criteria for periodontitis groups: Systemically healthy individuals with interdental CAL ≥ 5 mm and PPD ≥ 6 mm were included.
- Inclusion criteria for periodontitis with diabetes groups: Type 2 diabetes patients with interdental CAL ≥ 5 mm, PPD ≥ 6 mm, and HbA1c ≥ 6.5% were included.
The plaque index (PI), gingival index (GI), presence of bleeding on probing (BOP), PD, and clinical AL were used for clinical periodontal assessments. All assessments were done with a manual probe. GCF samples were obtained and analyzed using an enzyme-linked immunosorbent assay.
- Conditions
- Periodontitis, Diabetes
- Being tested
- Gingival crevicular fluid
- Keywords
- Diabetes,, periodontitis, cytokines
- Medical subject headings
- Periodontitis, Diabetes Mellitus
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 | individuals with clinically healthy gingiva BOP score less than 10% and PD≤3mm Receives: Diagnostic Test: Gingival crevicular fluid | |
| Periodontitis group | interdental AL ≥5 mm Receives: Diagnostic Test: Gingival crevicular fluid | |
| Periodontitis with diabetes group | HbA1c ≥6.5% Receives: Diagnostic Test: Gingival crevicular fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
It was aimed to compare IL-34 levels by taking gingival crevicular fluid in systemic healthy, periodontitis and diabetic patients with periodontitis groups.
GCF was taken interproximal region.
Measured: GCF samples taken within the 1. week after the clinical examination of the patient
Secondary outcomes (1)
It was aimed to compare CSF-1 levels by taking gingival crevicular fluid in systemic healthy, periodontitis and diabetic patients with periodontitis groups.
GCF was taken interproximal region.
Measured: GCF samples taken within the 1. week after the clinical examination of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start6 Jan 2021
- Primary completion21 Apr 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 76 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ahu dikilitas, Principal investigator, University of Usak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891627
- Sponsor's protocol ID
- UsakU8
- Status last verified
- Jan 2023
- First submitted
- 13 May 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dikilitas A, Karaaslan F, Evirgen S, Ertugrul AS. Gingival crevicular fluid CSF-1 and IL-34 levels in patients with stage III grade C periodontitis and uncontrolled type 2 diabetes mellitus. J Periodontal Implant Sci. 2022 Dec;52(6):455-465. doi: 10.5051/jpis.2106260313. Epub 2022 Apr 12.
PubMed 36468466
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usak University Faculty of Dentistry
- ClinicalTrials.gov ID
- NCT04891627
- Acronym / sponsor ID
- UsakU8
- Conditions
- Periodontitis, Diabetes
- Keywords
- Diabetes,, periodontitis, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 18 May 2021 (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.
Type 2 diabetes mellitus is a metabolic disorder. There is a bidirectional association between periodontal disease and DM. Currently there is no data relationship between CSF-1 and IL-34, periodontal disease and diabetes.The aim of this study to investigate GCF levels of IL-34 and CSF-1 in periodontitis subjects with diabetes.
Detailed description
Periodontally healthy (H), periodontitis, and periodontitis with diabetes patients, were recruited for this study.
- Inclusion criteria for H groups: Individuals with clinically healthy gingiva, no attachment and bone loss, and less than 10% bleeding on probing were included.
- Inclusion criteria for periodontitis groups: Systemically healthy individuals with interdental CAL ≥ 5 mm and PPD ≥ 6 mm were included.
- Inclusion criteria for periodontitis with diabetes groups: Type 2 diabetes patients with interdental CAL ≥ 5 mm, PPD ≥ 6 mm, and HbA1c ≥ 6.5% were included.
The plaque index (PI), gingival index (GI), presence of bleeding on probing (BOP), PD, and clinical AL were used for clinical periodontal assessments. All assessments were done with a manual probe. GCF samples were obtained and analyzed using an enzyme-linked immunosorbent assay.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control groups | – | Diagnostic Test: Gingival crevicular fluidindividuals with clinically healthy gingiva BOP score less than 10% and PD≤3mm |
| Periodontitis group | – | Diagnostic Test: Gingival crevicular fluidinterdental AL ≥5 mm |
| Periodontitis with diabetes group | – | Diagnostic Test: Gingival crevicular fluidHbA1c ≥6.5% |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals have diabetes and periodontitis
Key inclusion criteria (2 listed)
- have 20 teeth
- have diabetes .
Key exclusion criteria (4 listed)
- Individuals have systemic disease
- smokers;
- pregnant
- those 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 | Healthy control groups, Periodontitis group, Periodontitis with diabetes group |
Primary outcome
It was aimed to compare IL-34 levels by taking gingival crevicular fluid in systemic healthy, periodontitis and diabetic patients with periodontitis groups.
Time frame: GCF samples taken within the 1. week after the clinical examination of the patient
GCF was taken interproximal region.
1 secondary outcome
It was aimed to compare CSF-1 levels by taking gingival crevicular fluid in systemic healthy, periodontitis and diabetic patients with periodontitis groups.
Time frame: GCF samples taken within the 1. week after the clinical examination of the patient
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 12 Jan 2023.
- Derived from this study: PubMed 36468466Dikilitas A, Karaaslan F, Evirgen S, Ertugrul AS. Gingival crevicular fluid CSF-1 and IL-34 levels in patients with stage III grade C periodontitis and uncontrolled type 2 diabetes mellitus. J Periodontal Implant Sci. 2022 Dec;52(6):455-465. doi: 10.5051/jpis.2106260313. Epub 2022 Apr 12.
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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 dikilitas principal investigator
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 and Diabetes, 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 4 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 12 Jan 2023. 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?
It was aimed to compare IL-34 levels by taking gingival crevicular fluid in systemic healthy, periodontitis and diabetic patients with periodontitis groups. (time frame: GCF samples taken within the 1. week after the clinical examination of the patient). 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 NCT04891627, which also lists 1 linked publication.
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 Jan 2023.