Periodontal Disease (Diagnosis)NCT04012983
Possible Role of Gingival Crevicular Fluid Levels of Chemerin and Fibroblast Growth Factor 21 as Biomarkers of Periodontal Disease in Diabetic and Non-diabetic Patients
An observational study of Periodontal Disease (Diagnosis) and Diabetes Mellitus, Type 2, run by Cairo University at 1 site in Egypt.
Trial summary
The current study aims to spot the light on the possible role of gingival crevicular fluid (GCF) level of Chemerin and FGF21 to study their potential role as biomarkers of periodontal disease and to understand their role in the link between periodontitis and diabetes . Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease (Diagnosis), Diabetes Mellitus, Type 2
- What is being tested?
- gingival crevicular fluid level
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 1 Sep 2018
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: forty five individuals (ranging in age from 35-60 years) recruited from the outpatient clinic of Oral Medicine, and Periodontology Department, Faculty of Dentistry, Cairo University The participants were divided into the following three groups: Group (1): 15 patients with periodontitis and controlled t2DM and no other systemic disease. Group (2): 15 systemically healthy individuals having periodontitis. Group (3): 15 periodontally and systemically healthy individuals.
Who may be able to join
- age range between 35 and 60 years
- a minimum of 20 natural teeth.
- Type 2DM patients exhibiting HbA1c 6-8% and FPG ≥126 mg/dL for more than one year who did not complain of any systemic diseases other than t2DM
- periodontitis patients with moderate to severe periodontitis having gingival index GI ≥ 1, probing depth PD ≥ 5, and clinical attachment level CAL ≥ 4 mm, and bone loss affecting > 30% of existing teeth on clinical/radiographic examination
Who cannot join
- uncontrolled diabetes mellitus
- systemic diseases which may affect the biomarkers levels and the periodontal conditions.
- Exposure to steroid therapies, radiation/immune-suppressive therapies.
- Allergic reaction to any kind of drug.
- Smoking over the past 5 years.
- Periapical pathologies.
- Exposure to mechanical forces as a result of occlusion/ orthodontics.
- History of periodontal or drug therapies within the previous 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
The current study aims to spot the light on the possible role of gingival crevicular fluid (GCF) level of Chemerin and FGF21 to study their potential role as biomarkers of periodontal disease and to understand their role in the link between periodontitis and diabetes .
The study will be conducted on three groups; group (A) include fifteen controlled T2 DM patients suffering from periodontitis, group (B) include fifteen patients suffering from periodontitis alone, and group C) include fifteen periodontally and medically healthy individuals. GCF samples will be collected from all participants for assessment of Chemerin and FGF 21. Samples will be analysed using ELISA technique.
- Being tested
- gingival crevicular fluid level
- Medical subject headings
- Periodontal Diseases, Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gingival crevicular fluid levelDiagnostic test
gingival crevicular fluid collection
| Study group | Role | What they receive |
|---|---|---|
| diabetic patients with periodontitis | Not described Receives: Diagnostic Test: gingival crevicular fluid level | |
| periodontitis patients | Not described Receives: Diagnostic Test: gingival crevicular fluid level | |
| healthy control | Not described Receives: Diagnostic Test: gingival crevicular fluid level |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of diabetic patients with periodontitis
assessment of GCF FGF21 in diabetic patients with periodontitis
Measured: baseline
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of periodontitis patients
assessment of GCF FGF21 in patients with periodontitis
Measured: baseline
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of healthy controls
assessment of GCF FGF21 in healthy individuals
Measured: baseline
Secondary outcomes (3)
measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of diabetic patients with periodontitis
assessment of GCF chemerin in diabetic patients with periodontitis
Measured: baseline
measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of periodontitis patients
assessment of GCF chemerin in patients with periodontitis
Measured: baseline
measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of healthy controls
assessment of GCF chemerin in healthy individuals
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Mar 2018
- Primary completion1 Aug 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Disease (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed Amr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012983
- Sponsor's protocol ID
- chemerin and FGF21
- Status last verified
- Jul 2019
- First submitted
- 3 Jul 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Role of Gingival Crevicular Fluid Levels of Chemerin and Fibroblast Growth Factor 21 as Biomarkers of Periodontal Disease in Diabetic and Non-diabetic Patients
- ClinicalTrials.gov ID
- NCT04012983
- Acronym / sponsor ID
- chemerin and FGF21
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 9 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.
The current study aims to spot the light on the possible role of gingival crevicular fluid (GCF) level of Chemerin and FGF21 to study their potential role as biomarkers of periodontal disease and to understand their role in the link between periodontitis and diabetes .
The study will be conducted on three groups; group (A) include fifteen controlled T2 DM patients suffering from periodontitis, group (B) include fifteen patients suffering from periodontitis alone, and group C) include fifteen periodontally and medically healthy individuals. GCF samples will be collected from all participants for assessment of Chemerin and FGF 21. Samples will be analysed using ELISA technique.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| diabetic patients with periodontitis | – | Diagnostic Test: gingival crevicular fluid level |
| periodontitis patients | – | Diagnostic Test: gingival crevicular fluid level |
| healthy control | – | Diagnostic Test: gingival crevicular fluid level |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- forty five individuals (ranging in age from 35-60 years) recruited from the outpatient clinic of Oral Medicine, and Periodontology Department, Faculty of Dentistry, Cairo University The participants were divided into the following three groups: Group (1): 15 patients with periodontitis and controlled t2DM and no other systemic disease. Group (2): 15 systemically healthy individuals having periodontitis. Group (3): 15 periodontally and systemically healthy individuals.
Key inclusion criteria (4 listed)
- age range between 35 and 60 years
- a minimum of 20 natural teeth.
- Type 2DM patients exhibiting HbA1c 6-8% and FPG ≥126 mg/dL for more than one year who did not complain of any systemic diseases other than t2DM
- periodontitis patients with moderate to severe periodontitis having gingival index GI ≥ 1, probing depth PD ≥ 5, and clinical attachment level CAL ≥ 4 mm, and bone loss affecting > 30% of existing teeth on clinical/radiographic examination
Key exclusion criteria (8 listed)
- uncontrolled diabetes mellitus
- systemic diseases which may affect the biomarkers levels and the periodontal conditions.
- Exposure to steroid therapies, radiation/immune-suppressive therapies.
- Allergic reaction to any kind of drug.
- Smoking over the past 5 years.
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 fluid levelgingival crevicular fluid collection | Diagnostic test | diabetic patients with periodontitis, healthy control, periodontitis patients |
Primary outcome
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of diabetic patients with periodontitis
Time frame: baseline
assessment of GCF FGF21 in diabetic patients with periodontitis
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of periodontitis patients
Time frame: baseline
assessment of GCF FGF21 in patients with periodontitis
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of healthy controls
Time frame: baseline
assessment of GCF FGF21 in healthy individuals
3 secondary outcomes
measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of diabetic patients with periodontitis
Time frame: baseline
measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of periodontitis patients
Time frame: baseline
measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of healthy controls
Time frame: baseline
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 16 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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 Periodontal Disease (Diagnosis) and Diabetes Mellitus, Type 2, run by Cairo University at 1 site in Egypt.
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 8 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 16 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 Egypt. 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 the level of FGF21 (pg/ml) in gingival crevicular fluid of diabetic patients with periodontitis (time frame: baseline). The study lists 3 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 16 Jul 2019.