Cathelicidin LL-37 Levels in the GCF and the Saliva of Smokers and Non-smokers With Stage III,IV Periodontitis

NCT04861493 | Completed DMC

• 1 other identifier: 9221
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is considered an inflammatory disease that results in the disruption of oral hemeostasis and is associated with the presence of dental plaque influenced by genetic and environmental factors. It is well-establised that smokers have an increased severity of periodontal disease,a higher prevalance of tooth loss and total edentulism.

Conditions

Smoking Reduction

Outcome Measures

Primary Outcomes (1)

• LL-37 levels in the GCF and saliva

  GCF,Saiva sampling to assess LL-37 levels by ELISA kit.

  Through study completion,an average of 1 year

Study Arms (3)

Smokers with stage III,IV periodontitis

patients with stage III,IV periodontitis having CAL\>5 mm and PD\>5 mm in one or more sites and bleeding on probing \>30% and smoking at least 10 cigarettes /day for a minmum of 5 years.

Non-smokers with stage III,IV periodontitis

patients with stage III,IV periodontitis having CAL\>5 mm and PD\>5 mm in one or more sites and bleeding on probing \>30% and they are never smoked before.

Healthy patients

patients free from periodontitis or any systemic disease and never smoked before.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group 1: Smokers with stage III,IV periodontitis Group 2: Non-smokers with stage III,IV periodontitis Group 3: Healthy patients

You may qualify if:

• Presence of a minimum of 15 natural teeth.
• At least four non-adjacent teeth sites in each jaw having CAL ≥ 5 mm and PD \> 5 mm in one or more sites.
• Bleeding on probing (BOP) ≥ 30%.
• Tooth loss due to periodontitis ≤ 4 teeth.
• For smoker's patients; study will include patients who regularly smoked at least 10 cigarettes/day for a minimum of 5 years.
• For non-smokers patients; study will include patients who had never smoked.

You may not qualify if:

• Individuals with a history of systemic diseases or immunological disorders.
• Individuals using hormone replacement therapy.
• Pregnant and lactating women.
• Individuals that received periodontal treatment within the last 6 months.
• Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry cairo university

Al Manyal, Cairo Governorate, 11562, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid samples Saliva samples

MeSH Terms

Conditions

Smoking Reduction

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Study Officials

• Ghallab

  main supervisor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 27, 2021
• Study Start: February 23, 2021
• Primary Completion: February 23, 2021
• Study Completion: April 15, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)