Role of NLRP3 in Periodontitis and Diabetes
Evaluation of Serum and Salivary NLRP3 in Periodontitis and Diabetes Patients
1 other identifier
observational
133
1 country
1
Brief Summary
NLRP3 plays a key role in endothelial function and may be a link for the known interaction of periodontitis and diabetes. The investigators compared the impact of gingival health, periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum NLRP3levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
Typical duration 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
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2017
CompletedFirst Submitted
Initial submission to the registry
June 24, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedJanuary 26, 2021
January 1, 2021
3.3 years
June 24, 2020
January 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical attachment level
evaluation of changes in clinical attachment level
1-year
Study Arms (4)
Control
Evaluation of serum and salivary NLRP3
Periodontitis
Evaluation of serum and salivary NLRP3
Diabetes
Evaluation of serum and salivary NLRP3
Periodontitis + diabetes
Evaluation of serum and salivary NLRP3
Interventions
Evaluation of serum and salivary NLRP3 levels
Eligibility Criteria
healthy controls (n=32), periodontitis (n=34), diabetes (n=33), and a combination of periodontitis + diabetes (n=34)
You may qualify if:
- Presence of at least 15 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
June 24, 2020
First Posted
June 30, 2020
Study Start
June 1, 2014
Primary Completion
September 18, 2017
Study Completion
September 30, 2017
Last Updated
January 26, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- 10 tears
- Access Criteria
- pubmed
all collected IPD, all IPD that underlie results in a publication