Evaluation of Saliva IL-6 Levels and Periodontitis

Periodontal Diseases Clinical Trial

Official title:

Association Between Salivary IL-6 and Extent of Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382105
• Other study ID #: 11-1818
• Status: Completed
• Start date: November 8, 2015
• Est. completion date: September 25, 2019

Study information

• Verified date: November 2020
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: September 25, 2019
• Est. primary completion date: September 15, 2019
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

Other:
• Observation of salivary IL-6 levels
Observation of salivary IL-6 levels and correlation of salivary IL-6 levels with periodontal disease

Locations

Country	Name	City	State
Italy	University of Messina	Messina

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Attachment Level	evaluation of changes in clinical attachment level	1-year