Cathelicidin LL-37 Relation to Potentially Malignant Lesions

NCT06219330 | Completed

• 1 other identifier: 63723
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Potentially Malignant Lesions

Keywords

Oral potentially malignant lesions, Cathelicidin LL-37

Outcome Measures

Primary Outcomes (1)

• Cathelicidin LL-37 level in salivary samples from all participants mesured using ELISA

  ELISA is used to estimate Cathelicidin LL-37 levels in saliva samples from patients with OPMD compared to healthy subjects

  level of LL-37 is measured after the completion of all sample collection carried at the 1 day of enrollement of subjects in the investigation after diagnosis confirmation

Study Arms (3)

Group I (control group)

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

Group III:

15 Patients having oral leukoplakia

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total number of 45 systemically healthy participants were included in this study that were divided equally into 3 groups: Group I: 15 Healthy participants without any oral lesions. Group II: 15 Patients having atrophic/ erosive oral lichen planus. Group III: 15 Patients having oral leukoplakia.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead
• Cairo University: collaborator

Study Sites (1)

Sandy hassan shaaban

Cairo, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor oral medicine & periodontology departement

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 23, 2024
• Study Start: July 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: November 15, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)