Evaluation of Saliva IL-6 Levels and Periodontitis

Completed

• Conditions: Periodontal Diseases
• Interventions: Other: Observation of salivary IL-6 levels

• Registration Number: NCT04382105
• Lead Sponsor: University of Messina

Brief Summary

The aim of this study was to analyze the association between salivary IL-6 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced salivary IL-6 levels

Detailed Description

Forty-nine patients with periodontitis and 47 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis, and salivary IL-6 levels. The Spearman Correlation Test and Jonckheere-Terpstra Test were applied in order to assess the interdependence between salivary IL-6 levels and clinical periodontal parameters.

Study Timeline

• Study Start: 2015-11-08
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-25
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• Presence of at least 16 teeth

• CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;

• Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs

• Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria

• Intake of contraceptives
• Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
• Status of pregnancy or lactation
• Previous history of excessive drinking
• Allergy to local anaesthetic
• Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Observation of salivary IL-6 levels	observation of salivary IL-6 levels
Periodontitis	Observation of salivary IL-6 levels	observation of salivary IL-6 levels

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level	1-year	evaluation of changes in clinical attachment level

Trial Locations

Locations (1)

University of Messina; 🇮🇹 Messina, Italy