Evaluation of Saliva IL-6 Levels and Periodontitis
Association Between Salivary IL-6 and Extent of Periodontitis
1 other identifier
observational
287
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2019
CompletedFirst Submitted
Initial submission to the registry
May 6, 2020
CompletedFirst Posted
Study publicly available on registry
May 11, 2020
CompletedNovember 24, 2020
November 1, 2020
3.9 years
May 6, 2020
November 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Attachment Level
evaluation of changes in clinical attachment level
1-year
Study Arms (2)
Control
observation of salivary IL-6 levels
Periodontitis
observation of salivary IL-6 levels
Interventions
Observation of salivary IL-6 levels and correlation of salivary IL-6 levels with periodontal disease
Eligibility Criteria
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 P.Gingivalis antibodies were expressed and evaluated enzyme-linked immunosorbent assay (ELISA) units (EU).
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Messina
Messina, 98100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giovanni Matarese
University of Messina
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
May 6, 2020
First Posted
May 11, 2020
Study Start
November 8, 2015
Primary Completion
September 15, 2019
Study Completion
September 25, 2019
Last Updated
November 24, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 1-year
- Access Criteria
- Official website
all collected IPD, all IPD that underlie results in a publication