Role of NLRP3 in Periodontitis and Diabetes

Completed

• Conditions: Periodontal Diseases; Metabolic Disease
• Interventions: Other: Observation of serum and salivary NLRP3 levels

• Registration Number: NCT04450810
• Lead Sponsor: University of Messina

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2017-09-18
• Study Completion: 2017-09-30
• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-23
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Periodontitis	Observation of serum and salivary NLRP3 levels	Evaluation of serum and salivary NLRP3
Periodontitis + diabetes	Observation of serum and salivary NLRP3 levels	Evaluation of serum and salivary NLRP3
Control	Observation of serum and salivary NLRP3 levels	Evaluation of serum and salivary NLRP3
Diabetes	Observation of serum and salivary NLRP3 levels	Evaluation of serum and salivary NLRP3

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