Endocan Biomarker Level in Gingival Crevicular Fluid in Periodontitis Patients With Type 2 Diabetes Mellitus

An observational study of Periodontitis and Diabetes Mellitus, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Aim of the current study was to evaluate Endocan biomarker level in gingival crevicular fluid of patients with stage 1 or 2 (mild to moderate) periodontitis with controlled type 2 diabetes mellitus (DM) and compare it to that in DM free periodontitis patients. Read more about this study

Who is it for?: Ages 40 to 65 years
Conditions the study is for: Periodontitis, Diabetes Mellitus
How many people: 42 participants
Where: 1 siteEgypt
Study dates: 5 Apr 2022to 10 Sep 2022
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 40 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with stage 1 or 2 (mild to moderate) periodontitis having ≤ 4 mm attachment loss at least in one site were included in the study these were divided into two groups, with controlled type 2 diabetes mellitus, and systemically healthy stage 1 or 2 (mild to moderate) periodontitis patients

Who may be able to join

Probing pocket depths (PPD) ≤ 5 mm.
Clinical attachment level (CAL) ≤ 4 mm.
Type 2 DM, for at least the past 3 years.
HbA1c ≤ 7%.

Who cannot join

Uncontrolled Diabetes Mellitus.
Systemic antibiotic or anti-inflammatory medication use in the previous 2 months.
Non-surgical periodontal therapy in the previous 6 months.
Surgical periodontal therapy in the previous 12 months.
Use of calcium channel blockers, phenytoin, or cyclosporine.
Pregnancy.
Smokers

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Alexandria University
Alexandria, 21527

Other trials in Egypt

About this study

Official title: Endocan Biomarker Level in Gingival Crevicular Fluid in Periodontitis Patients With Type 2 Diabetes Mellitus [A Comparative Cross-Sectional Study]

Conditions: Periodontitis, Diabetes Mellitus
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.

Study groups in NCT05667051
Study group	Role	What they receive
Controlled type 2 diabetes mellitus		Not described
Diabetes mellitus free patients		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Endocan level
Endocan level in gingival crevicular samples was assessed by commercially available ELISA kit (Bioneovan Co., Ltd, Elisa Human Endocan/esm-1 ELISA Kit. Beijing, China). Assays were performed according to the manufacturer's instructions. Color change will be measured with a microplate reader (Hellma GmbH \& Co. KG. Müllheim, Germany) at 450 nm. Concentrations were determined based on the respective assay standard curve. All samples were run in duplicate and values will be averaged
Measured: Day 1
Pocket probing depth (PPD)
PPD was assessed at six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth at all teeth present, except third molars. PPD was assessed using Williams calibrated periodontal probe and recordings were made to the nearest mm; observations close to 0.5 mm were rounded to the upper whole mm.
Measured: Day 1
Clinical Attachment Level (CAL)
CAL was assessed at six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth at all teeth present, except third molars. CAL was assessed using Williams calibrated periodontal probe and recordings were made to the nearest mm; observations close to 0.5 mm were rounded to the upper whole mm.
Measured: Day 1
Percentage of bleeding on probing sites (BOP%)
BOP% was assessed at six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth at all teeth present, except third molars. BOP% was assessed using Williams calibrated periodontal probe and the number of sites with BOP were divided by the total number of examined sites and multiplied by 100 to calculate the percentage
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Apr 202210 Sep 2022

First posted28 Dec 2022
Study start5 Apr 2022
Primary completion1 Sep 2022
Study completion10 Sep 2022

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 Alexandria 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: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05667051
Sponsor's protocol ID: #256
Status last verified: Dec 2022
First submitted: 19 Dec 2022
Last updated: 28 Dec 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Endocan Biomarker Level in Gingival Crevicular Fluid in Periodontitis Patients With Type 2 Diabetes Mellitus [A Comparative Cross-Sectional Study]
ClinicalTrials.gov ID: NCT05667051
Acronym / sponsor ID: #256
Conditions: Periodontitis, Diabetes Mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Alexandria UniversityUniversity, hospital or other
Study start: 5 Apr 2022 (actual)
Primary completion: 1 Sep 2022 (actual)
Study completion: 10 Sep 2022 (actual)
First posted: 28 Dec 2022 (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.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Controlled type 2 diabetes mellitus	–	–
Diabetes mellitus free patients	–	–

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with stage 1 or 2 (mild to moderate) periodontitis having ≤ 4 mm attachment loss at least in one site were included in the study these were divided into two groups, with controlled type 2 diabetes mellitus, and systemically healthy stage 1 or 2 (mild to moderate) periodontitis patients

Key inclusion criteria (4 listed)

Probing pocket depths (PPD) ≤ 5 mm.
Clinical attachment level (CAL) ≤ 4 mm.
Type 2 DM, for at least the past 3 years.
HbA1c ≤ 7%.

Key exclusion criteria (7 listed)

Uncontrolled Diabetes Mellitus.
Systemic antibiotic or anti-inflammatory medication use in the previous 2 months.
Non-surgical periodontal therapy in the previous 6 months.
Surgical periodontal therapy in the previous 12 months.
Use of calcium channel blockers, phenytoin, or cyclosporine.

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

Endocan level
Time frame: Day 1
Endocan level in gingival crevicular samples was assessed by commercially available ELISA kit (Bioneovan Co., Ltd, Elisa Human Endocan/esm-1 ELISA Kit. Beijing, China). Assays were performed according to the manufacturer's instructions. Color change will be measured with a microplate reader (Hellma GmbH \& Co. KG. Müllheim, Germany) at 450 nm. Concentrations were determined based on the respective assay standard curve. All samples were run in duplicate and values will be averaged
Pocket probing depth (PPD)
Time frame: Day 1
PPD was assessed at six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth at all teeth present, except third molars. PPD was assessed using Williams calibrated periodontal probe and recordings were made to the nearest mm; observations close to 0.5 mm were rounded to the upper whole mm.
Clinical Attachment Level (CAL)
Time frame: Day 1
CAL was assessed at six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth at all teeth present, except third molars. CAL was assessed using Williams calibrated periodontal probe and recordings were made to the nearest mm; observations close to 0.5 mm were rounded to the upper whole mm.
Percentage of bleeding on probing sites (BOP%)
Time frame: Day 1
BOP% was assessed at six different sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth at all teeth present, except third molars. BOP% was assessed using Williams calibrated periodontal probe and the number of sites with BOP were divided by the total number of examined sites and multiplied by 100 to calculate the percentage

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 28 Dec 2022.

Related trials for Periodontitis

Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics

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.

Emad Ayyad, BDS principal investigator

Faculty of Dentistry, Alexandria University, Egypt

Maha Abou Khadr, PhD study director

Faculty of Dentistry, Alexandria University, Egypt

Mona Ayyad, PhD study chair

Faculty of Medicine, Alexandria University, Egypt

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 Mellitus, run by Alexandria 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 7 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 28 Dec 2022. 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?

Endocan level (time frame: Day 1). The study lists 4 primary outcomes in all. 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 NCT05667051.

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 28 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.