Role of NLRP3 in Periodontitis and Diabetes

NCT ID: NCT04450810

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-01

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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The aim of this study was to evaluate a possible association between NLRP3 and gingival health, periodontitis (CP), diabetes or of both diseases (CP +diabetes) on saliva and serum NLRP3 levels.

Conditions

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Metabolic Disease Periodontal Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

Evaluation of serum and salivary NLRP3

Observation of serum and salivary NLRP3 levels

Intervention Type OTHER

Evaluation of serum and salivary NLRP3 levels

Periodontitis

Evaluation of serum and salivary NLRP3

Observation of serum and salivary NLRP3 levels

Intervention Type OTHER

Evaluation of serum and salivary NLRP3 levels

Diabetes

Evaluation of serum and salivary NLRP3

Observation of serum and salivary NLRP3 levels

Intervention Type OTHER

Evaluation of serum and salivary NLRP3 levels

Periodontitis + diabetes

Evaluation of serum and salivary NLRP3

Observation of serum and salivary NLRP3 levels

Intervention Type OTHER

Evaluation of serum and salivary NLRP3 levels

Interventions

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Observation of serum and salivary NLRP3 levels

Evaluation of serum and salivary NLRP3 levels

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Messina

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola, DDS, PhD

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giovanni Matarese

Role: STUDY_CHAIR

University of Messina

Locations

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University of Messina

Messina, , Italy

Site Status

Countries

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Italy

Other Identifiers

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23-18

Identifier Type: -

Identifier Source: org_study_id

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