NCT07157878

Brief 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. 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

Same day

First QC Date

August 19, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

PeriodontitisLDLGCFperiodontal health

Outcome Measures

Primary Outcomes (1)

  • 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.

    at baseline (day1)

Study Arms (2)

control group

periodontally healthy participants

study group

periodontitis stage 3 and 4

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

cross sectional study in upper egypt to detect the level of LDL in advanced periodontitis patient

You may qualify if:

  • 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.

You may not qualify if:

  • \. History of systemic diseases affecting periodontium (e.g., uncontrolled diabetes, autoimmune diseases, osteoporosis).
  • \. Current or past diagnosis of Alzheimer's disease or other neurodegenerative disorders.
  • \. Use of medications affecting periodontal status (e.g., immunosuppressants, long-term corticosteroids, anticonvulsants).
  • \. Antibiotic or anti-inflammatory therapy within the past 3 months. 5. Current smokers or history of smoking in the past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

A gingival crevicular fluid sample was taken for LDL detection to assess the correlation between periodontitis and LDL

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • shaimaa Hamdy, lecturer

    lecturer of periodontology Nahda University

    STUDY CHAIR

Central Study Contacts

shaimaa Hamdy, lecturer of Periodontology

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of periodontology

Study Record Dates

First Submitted

August 19, 2025

First Posted

September 5, 2025

Study Start

September 15, 2025

Primary Completion

September 15, 2025

Study Completion

September 15, 2025

Last Updated

September 5, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

After completion of the study and complete publication, I will share all data