Cathelicidin LL-37 Relation to Potentially Malignant Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-11-15

Brief Summary

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LL-37 appears to have a potential role in potentially malignant lesions (OLP \& leukoplakia). The remarkable diagnostic accuracy of salivary LL-37 in differentiating potentially malignant lesion and healthy control could confirm its utilization as an innovative marker to early diagnose potentially malignant lesions. Salivary LL-37 being non-invasive accurate marker could be as a chair-side diagnostic method that detect potentially malignant lesions.

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Detailed Description

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Aim: The recognition of practical early diagnostic biomarkers is a cornerstone of improved prevention and treatment of cancer thus the current study estimated salivary level of Cathelicidin LL-37 in patients suffering from potentially malignant lesions and control subjects to corroborate Cathelicidin LL-37 as a diagnostic marker for early detection of potentially malignant diseases and revealing its possible role in carcinogenesis.

Methodology: 45 systemically healthy individuals were subdivided into three groups: Group I: 15 Healthy participants without any oral lesions. Group II: 15 Patients having atrophic/erosive oral lichen planus (OLP). Group III: 15 Patients having oral leukoplakia.. Enzyme linked immune-sorbent assay (ELIZA) kit was used to evaluate the level of LL-37 in whole unstimulated salivary samples collected from all participants. To reveal AUC, sensitivity, specificity, and diagnostic accuracy of LL-37 receiver operating curve (ROC) analysis was done.

Conditions

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Oral Potentially Malignant Lesions

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group I (control group)

15 Healthy participants without any oral lesions

No interventions assigned to this group

Group II:

15 Patients having atrophic/erosive oral lichen planus (OLP). Group III: 15 Patients having oral leukoplakia

No interventions assigned to this group

Group III:

15 Patients having oral leukoplakia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Both genders with age range 30 - 70 years.
* Patients agreed to sign a written consent after understanding the nature of the study.
* Clinically diagnosed and histologically confirmed as having oral potentially malignant lesions mainly atrophic/erosive oral lichen planus and oral leukoplakia.

Exclusion Criteria

* Systemic diseases as well as pregnant or lactating females.
* Patients currently taking corticosteroids, immunosuppressives drugs, contraceptive pills, or antibiotics.
* Patients are diagnosed with any other oral lesions other than oral lichen planus and oral leukoplakia.
* Vulnerable subjects as prisoners, or mentally disabled.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes