Periodontitis, AdultNCT06064786
Fetuin A Association in Periodontal Disease and Diabetes Mellitus
An observational study of Periodontitis, Adult, run by Fayoum University at 1 site in Egypt.
Trial summary
Aim: The aim of the current study was to compare and correlate gingival crevicular fluid (GCF) fetuin-A levels and high sensitivity C-reactive protein (hs-CRP) levels in non-diabetic periodontitis patients and type 2 diabetic periodontitis patients with healthy subjects and revealing its possible role in diagnosis of… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- GCF levels of fetuin A and hsCRP evaluation
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 15 Sep 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: individuals recruited from outpatient clinic of periodontology department
Who may be able to join
- both gender periodontitis stage III
Who cannot join
- Smoking,
- Systemic diseases (except DM in group B),
- Periodontitis patients having periodontal treatment recently (past 6 months),
- Pregnancy, lactation, contraceptive pills,
- Anti-inflammatory/ immunosuppressive drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Fetuin-A and hsCRP Levels in Gingival Crevicular Fluid in Periodontitis Diabetic and Non-Diabetic Patients
Aim: The aim of the current study was to compare and correlate gingival crevicular fluid (GCF) fetuin-A levels and high sensitivity C-reactive protein (hs-CRP) levels in non-diabetic periodontitis patients and type 2 diabetic periodontitis patients with healthy subjects and revealing its possible role in diagnosis of periodontal disease.
Methodology: Forty-five periodontitis stage III patients categorized into 3 groups according to whether having type II diabetes mellitus or not were compared to systemically and periodontally healthy participants in this investigation. Clinical parameters for all groups were recorded. Assessment of GCF levels of fetuin A and hs-CRP were done to all enrolled participants utilizing an enzyme linked immune-sorbent assay (ELISA) kit. Receiver operating characteristic (ROC) curve was performed to reveal sensitivity, specificity, predictive value and diagnostic accuracy of the markers used.
- Conditions
- Periodontitis, Adult
- Being tested
- GCF levels of fetuin A and hsCRP evaluation
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCF levels of fetuin A and hsCRP evaluationDiagnostic test
ELIZA kits are used for GCF levels of fetuin A and hsCRP evaluation
| Study group | Role | What they receive |
|---|---|---|
| Group I | 15 healthy patients with generalized periodontitis stage III. Receives: Diagnostic Test: GCF levels of fetuin A and hsCRP evaluation | |
| Group II | 15 patients suffering from type 2 diabetes mellitus with generalized periodontitis stage III Receives: Diagnostic Test: GCF levels of fetuin A and hsCRP evaluation | |
| Group III | 15 systemically healthy patients without periodontitis Receives: Diagnostic Test: GCF levels of fetuin A and hsCRP evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF levels of fetuin A and hsCRP evaluation in all groups
ELIZA kits
Measured: levels of fetuin A and hsCRP are measured at baseline after the completion of all GCF sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Aug 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayroz Tarrad, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064786
- Sponsor's protocol ID
- REC-FDBSU/03082023-2/ER
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 3 Oct 2023
- 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 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fetuin-A and hsCRP Levels in Gingival Crevicular Fluid in Periodontitis Diabetic and Non-Diabetic Patients
- ClinicalTrials.gov ID
- NCT06064786
- Acronym / sponsor ID
- REC-FDBSU/03082023-2/ER
- Conditions
- Periodontitis, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 3 Oct 2023 (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.
Aim: The aim of the current study was to compare and correlate gingival crevicular fluid (GCF) fetuin-A levels and high sensitivity C-reactive protein (hs-CRP) levels in non-diabetic periodontitis patients and type 2 diabetic periodontitis patients with healthy subjects and revealing its possible role in diagnosis of periodontal disease.
Methodology: Forty-five periodontitis stage III patients categorized into 3 groups according to whether having type II diabetes mellitus or not were compared to systemically and periodontally healthy participants in this investigation. Clinical parameters for all groups were recorded. Assessment of GCF levels of fetuin A and hs-CRP were done to all enrolled participants utilizing an enzyme linked immune-sorbent assay (ELISA) kit. Receiver operating characteristic (ROC) curve was performed to reveal sensitivity, specificity, predictive value and diagnostic accuracy of the markers used.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: GCF levels of fetuin A and hsCRP evaluation15 healthy patients with generalized periodontitis stage III. |
| Group II | – | Diagnostic Test: GCF levels of fetuin A and hsCRP evaluation15 patients suffering from type 2 diabetes mellitus with generalized periodontitis stage III |
| Group III | – | Diagnostic Test: GCF levels of fetuin A and hsCRP evaluation15 systemically healthy patients without periodontitis |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- individuals recruited from outpatient clinic of periodontology department
Key inclusion criteria (1 listed)
- both gender periodontitis stage III
Key exclusion criteria (5 listed)
- Smoking,
- Systemic diseases (except DM in group B),
- Periodontitis patients having periodontal treatment recently (past 6 months),
- Pregnancy, lactation, contraceptive pills,
- Anti-inflammatory/ immunosuppressive 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 |
|---|---|---|
| GCF levels of fetuin A and hsCRP evaluationELIZA kits are used for GCF levels of fetuin A and hsCRP evaluation | Diagnostic test | Group I, Group II, Group III |
Primary outcome
GCF levels of fetuin A and hsCRP evaluation in all groups
Time frame: levels of fetuin A and hsCRP are measured at baseline after the completion of all GCF sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation
ELIZA kits
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 3 Oct 2023.
- 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.
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 Periodontitis, Adult, run by Fayoum 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 1 inclusion and 5 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 3 Oct 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 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?
GCF levels of fetuin A and hsCRP evaluation in all groups (time frame: levels of fetuin A and hsCRP are measured at baseline after the completion of all GCF sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation). 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 3 Oct 2023.