PeriodontitisNCT03964428
Serum Ferritin and Hepicidin Concentration in Chronic Periodontitis Patients With T2DM
An observational study of Periodontitis and Type2 Diabetes, run by Fayoum University at 1 site in Egypt.
Trial summary
serum level of ferritin and hepicidin were evaluated in periodontitis patient with and without type 2 diabetes before and after non surgical periodontal treatment to clarify their in periodontal disease Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Periodontitis, Type2 Diabetes
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 30 Jan 2019
- 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 30 to 50 years
- All sexes
- Adult
Study population: participants were collected from the Outpatient Clinic, Department of Oral Medicine, Periodontology and Diagnosis, and the restorative clinic for the control subjects, Faculty of Oral and Dental Medicine, fayoum University
Who may be able to join
- patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm with T2DM
- systemically healthy patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm
- healthy subjects had clinically healthy gingiva with ≤ 3mm pocket probing depth (PPD), nearly zero plaque index (PI), gingival index (GI), zero CAL.
Who cannot join
- (I) Pregnancy or lactation, (II) History of receiving professional periodontal treatment during the past 6 months; (III) Treatment with any type of medications and/ or antibiotics during the past 3 months and (IV) Current or former smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decreased Ferritin And Increased Hepcidin Serum Levels In Periodontitis Patients With Diabetes Mellitus Type 2. Controlled Before-And-After Study
serum level of ferritin and hepicidin were evaluated in periodontitis patient with and without type 2 diabetes before and after non surgical periodontal treatment to clarify their in periodontal disease
- Conditions
- Periodontitis, Type2 Diabetes
- Keywords
- periodontitis, ferritin, hepicidin, type 2 diabetes mellitus, non surgical perioontal therapy
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2
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 |
|---|---|---|
| periodontitis | Not described | |
| periodontitis with T2DM | Not described | |
| control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ferritin concentration
ng/ml
Measured: 0-3 months
hepicidin concentration
ng/ml
Measured: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Sep 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
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.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayroz Abdel Fattah Mohamed Tarrad, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964428
- Sponsor's protocol ID
- fayoum dentistry
- Status last verified
- Jun 2019
- First submitted
- 23 May 2019
- Last updated
- 11 Jun 2019
- 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 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreased Ferritin And Increased Hepcidin Serum Levels In Periodontitis Patients With Diabetes Mellitus Type 2. Controlled Before-And-After Study
- ClinicalTrials.gov ID
- NCT03964428
- Acronym / sponsor ID
- fayoum dentistry
- Conditions
- Periodontitis, Type2 Diabetes
- Keywords
- periodontitis, ferritin, hepicidin, type 2 diabetes mellitus, non surgical perioontal therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 28 May 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.
serum level of ferritin and hepicidin were evaluated in periodontitis patient with and without type 2 diabetes before and after non surgical periodontal treatment to clarify their in periodontal disease
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periodontitis | – | – |
| periodontitis with T2DM | – | – |
| control | – | – |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- participants were collected from the Outpatient Clinic, Department of Oral Medicine, Periodontology and Diagnosis, and the restorative clinic for the control subjects, Faculty of Oral and Dental Medicine, fayoum University
Key inclusion criteria (3 listed)
- patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm with T2DM
- systemically healthy patients with more than 30% of the sites had clinical attachment level (CAL) 3-4mm
- healthy subjects had clinically healthy gingiva with ≤ 3mm pocket probing depth (PPD), nearly zero plaque index (PI), gingival index (GI), zero CAL.
Key exclusion criteria (1 listed)
- (I) Pregnancy or lactation, (II) History of receiving professional periodontal treatment during the past 6 months; (III) Treatment with any type of medications and/ or antibiotics during the past 3 months and (IV) Current or former smokers.
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
ferritin concentration
Time frame: 0-3 months
ng/ml
hepicidin concentration
Time frame: 0-3 months
ng/ml
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 11 Jun 2019.
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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 and Type2 Diabetes, 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 3 inclusion and 1 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 11 Jun 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?
ferritin concentration (time frame: 0-3 months). 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 11 Jun 2019.