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

Smoking Reduction Clinical Trial

Official title:

Cathelicidin LL-37 Levels in the Gingival Crevicular Fluid and the Saliva of Smokers and Non-smokers With Stage III,IV Periodontitis :An Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04861493
• Other study ID #: 9221
• Status: Completed
• Start date: February 23, 2021
• Est. completion date: April 15, 2021

Study information

• Verified date: April 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Antimicrobial peptides (AMPs) are soluble molecules participating in the innate immunity of mucosal surfaces against pathogens. Dysregulated expression of AMPs has been considered a possible causal mechanistic link in the microbial dysbiosis associated with periodontal disease and some risk factors, including tobacco smoking, diabetes mellitus, and obesity.Antimicrobial peptides as a part of innate immunity are important molecules that provide a balance between disease and health. Moreover, they are considered to be an important intermediate step in initiating an initial immune response against the microbial side of the gingival epithelium and in the transition to acquired immunity. Cathelicidins, in particular - which play an important role in regulating the immunological response of oral tissues, are a group of peptides released from neutrophil granules and they are present only in humans in the form of LL-37.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 15, 2021
• Est. primary completion date: February 23, 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Presence of a minimum of 15 natural teeth.

2. At least four non-adjacent teeth sites in each jaw having CAL = 5 mm and PD > 5 mm in one or more sites.

3. Bleeding on probing (BOP) = 30%.

4. Tooth loss due to periodontitis = 4 teeth.

5. For smoker's patients; study will include patients who regularly smoked at least 10 cigarettes/day for a minimum of 5 years.

6. For non-smokers patients; study will include patients who had never smoked.

Exclusion Criteria:

1. Individuals with a history of systemic diseases or immunological disorders.

2. Individuals using hormone replacement therapy.

3. Pregnant and lactating women.

4. Individuals that received periodontal treatment within the last 6 months.

5. Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.

Related Conditions & MeSH terms

• Periodontitis
• Smoking Reduction

Locations

Country	Name	City	State
Egypt	Faculty of dentistry cairo university	Al Manyal	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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