Periodontal DiseasesLDL in GCFNCT07157878
Gingival Crevicular Fluid Oxidized Low-Density Lipoprotein Levels in Health and Stage III/IV Periodontitis
An observational study of Periodontal Diseases and LDL Hyperlipoproteinemia, run by shaimaa hamdy.
Trial summary
Periodontitis is a chronic, multifactorial inflammatory disease primarily caused by dysbiotic plaque biofilms, characterized by the progressive destruction of the supporting structures of the teeth. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Periodontal Diseases, LDL Hyperlipoproteinemia
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 15 Sep 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cross sectional study in upper egypt to detect the level of LDL in advanced periodontitis patient
Who may be able to join
- For all participants (applies to both groups):
- Age 30-60 years.
- Systemically healthy (based on medical history and physician clearance, if needed).
- No history of periodontal treatment within the last 6 months.
Who cannot join
- 1. History of systemic diseases affecting periodontium (e.g., uncontrolled diabetes, autoimmune diseases, osteoporosis).
- 2. Current or past diagnosis of Alzheimer's disease or other neurodegenerative disorders.
- 3. Use of medications affecting periodontal status (e.g., immunosuppressants, long-term corticosteroids, anticonvulsants).
- 4. Antibiotic or anti-inflammatory therapy within the past 3 months. 5. Current smokers or history of smoking in the past year.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Gingival Crevicular Fluid Oxidized Low-Density Lipoprotein Levels in Health and Stage III/IV Periodontitis: A Cross-Sectional Comparative Study
Periodontitis is a chronic, multifactorial inflammatory disease primarily caused by dysbiotic plaque biofilms, characterized by the progressive destruction of the supporting structures of the teeth. In advanced stages (Stage III/IV), periodontitis leads to significant attachment and bone loss, often culminating in tooth loss and a negative impact on the patient's quality of life. Recent evidence has emphasized the systemic implications of periodontal inflammation, suggesting a bidirectional relationship between periodontitis and various systemic conditions, especially cardiovascular diseases
Read the detailed description
Oxidative stress has emerged as a key pathogenic mechanism linking periodontal inflammation with systemic diseases. Among the oxidative stress-related biomarkers, oxidized low-density lipoprotein (oxLDL) has gained attention due to its pro-inflammatory, atherogenic, and cytotoxic properties. oxLDL is known to accumulate in vascular walls and contributes to the initiation and progression of atherosclerosis. Its role in periodontal disease, however, remains less well characterized. Gingival crevicular fluid (GCF) is a non-invasive biological fluid that reflects the inflammatory status of the periodontal tissues. Measuring oxLDL levels in GCF may provide valuable insight into the local oxidative burden associated with periodontal destruction. It may also help elucidate the mechanistic link between periodontal and systemic inflammatory diseases. While several studies have investigated oxLDL levels in serum in patients with periodontitis, only limited data exist regarding its levels in GCF, particularly among elderly populations who are more prone to both periodontitis and oxidative stress-related diseases. Understanding these levels could provide novel biomarkers for disease severity and progression, potentially guiding future preventive and therapeutic strategies The detection of elevated oxLDL levels in gingival crevicular fluid (GCF) could therefore serve as a meaningful, site-specific biomarker for disease activity and severity in older populations. Investigating this relationship could enhance our understanding of the oxidative mechanisms underpinning periodontal breakdown and help identify new diagnostic or prognostic markers, particularly in geriatric patients with complex medical profiles Aim of the Study To compare the levels of oxidized low-density lipoprotein (oxLDL) in gingival crevicular fluid (GCF) between healthy individuals and patients with Stage III/IV periodontitis.
- Conditions
- Periodontal Diseases, LDL Hyperlipoproteinemia
- Keywords
- Periodontitis, LDL, GCF, periodontal health
- Medical subject headings
- Periodontal Diseases, Periodontitis
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 |
|---|---|---|
| control group | periodontally healthy participants | |
| study group | periodontitis stage 3 and 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of oxLDL in GCF
The concentration of oxLDL in GCF, measured in pg/mL, in geriatric patients with Stage III/IV periodontitis compared to periodontally healthy geriatric individuals.
Measured: at baseline (day1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- shaimaa hamdy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, shaimaa hamdy, Minia University
- Investigators
- shaimaa Hamdy, lecturer, Study chair, lecturer of periodontology Nahda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157878
- Sponsor's protocol ID
- GCF+ advanced periodontitis
- Other IDs
- committee 1166
- Acronym
- LDL in GCF
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After completion of the study and complete publication, I will share all data
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid Oxidized Low-Density Lipoprotein Levels in Health and Stage III/IV Periodontitis: A Cross-Sectional Comparative Study
- ClinicalTrials.gov ID
- NCT07157878
- Acronym / sponsor ID
- LDL in GCF / GCF+ advanced periodontitis
- Conditions
- Periodontal Diseases, LDL Hyperlipoproteinemia
- Keywords
- Periodontitis, LDL, GCF, periodontal health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- shaimaa hamdyUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 5 Sep 2025 (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.
Periodontitis is a chronic, multifactorial inflammatory disease primarily caused by dysbiotic plaque biofilms, characterized by the progressive destruction of the supporting structures of the teeth. In advanced stages (Stage III/IV), periodontitis leads to significant attachment and bone loss, often culminating in tooth loss and a negative impact on the patient's quality of life. Recent evidence has emphasized the systemic implications of periodontal inflammation, suggesting a bidirectional relationship between periodontitis and various systemic conditions, especially cardiovascular diseases
Detailed description
Oxidative stress has emerged as a key pathogenic mechanism linking periodontal inflammation with systemic diseases. Among the oxidative stress-related biomarkers, oxidized low-density lipoprotein (oxLDL) has gained attention due to its pro-inflammatory, atherogenic, and cytotoxic properties. oxLDL is known to accumulate in vascular walls and contributes to the initiation and progression of atherosclerosis. Its role in periodontal disease, however, remains less well characterized. Gingival crevicular fluid (GCF) is a non-invasive biological fluid that reflects the inflammatory status of the periodontal tissues. Measuring oxLDL levels in GCF may provide valuable insight into the local oxidative burden associated with periodontal destruction. It may also help elucidate the mechanistic link between periodontal and systemic inflammatory diseases. While several studies have investigated oxLDL levels in serum in patients with periodontitis, only limited data exist regarding its levels in GCF, particularly among elderly populations who are more prone to both periodontitis and oxidative stress-related diseases. Understanding these levels could provide novel biomarkers for disease severity and progression, potentially guiding future preventive and therapeutic strategies The detection of elevated oxLDL levels in gingival crevicular fluid (GCF) could therefore serve as a meaningful, site-specific biomarker for disease activity and severity in older populations. Investigating this relationship could enhance our understanding of the oxidative mechanisms underpinning periodontal breakdown and help identify new diagnostic or prognostic markers, particularly in geriatric patients with complex medical profiles Aim of the Study To compare the levels of oxidized low-density lipoprotein (oxLDL) in gingival crevicular fluid (GCF) between healthy individuals and patients with Stage III/IV periodontitis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –periodontally healthy participants |
| study group | – | –periodontitis stage 3 and 4 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cross sectional study in upper egypt to detect the level of LDL in advanced periodontitis patient
Key inclusion criteria (4 listed)
- For all participants (applies to both groups):
Key exclusion criteria (4 listed)
- 1. History of systemic diseases affecting periodontium (e.g., uncontrolled diabetes, autoimmune diseases, osteoporosis).
- 2. Current or past diagnosis of Alzheimer's disease or other neurodegenerative disorders.
- 3. Use of medications affecting periodontal status (e.g., immunosuppressants, long-term corticosteroids, anticonvulsants).
- 4. Antibiotic or anti-inflammatory therapy within the past 3 months. 5. Current smokers or history of smoking in the past year.
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
The concentration of oxLDL in GCF
Time frame: at baseline (day1)
The concentration of oxLDL in GCF, measured in pg/mL, in geriatric patients with Stage III/IV periodontitis compared to periodontally healthy geriatric individuals.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No. After completion of the study and complete publication, I will share all data
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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.
shaimaa Hamdy, lecturer study chair
lecturer of periodontology Nahda University
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and LDL Hyperlipoproteinemia, run by shaimaa hamdy.
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 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: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa Hamdy, lecturer of Periodontology (+201030576405, shimaa.3m.sh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of oxLDL in GCF (time frame: at baseline (day1)). 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 5 Sep 2025.