Role of NLRP3 in Periodontitis and Diabetes

• Sponsor: University of Messina (Other)
• Overall Status: Completed
• CT.gov ID: NCT04450810
• Collaborator: (none)
• Enrollment: 133
• Location: 1
• Actual Duration (Months): 40
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Disease; Periodontal Diseases	Other: Observation of serum and salivary NLRP3 levels

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 Design

• Study Type: Observational
• Actual Enrollment: 133 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Evaluation of Serum and Salivary NLRP3 in Periodontitis and Diabetes Patients
• Actual Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Sep 18, 2017
• Actual Study Completion Date: Sep 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Control Evaluation of serum and salivary NLRP3	Other: Observation of serum and salivary NLRP3 levels; Evaluation of serum and salivary NLRP3 levels
Periodontitis Evaluation of serum and salivary NLRP3	Other: Observation of serum and salivary NLRP3 levels; Evaluation of serum and salivary NLRP3 levels
Diabetes Evaluation of serum and salivary NLRP3	Other: Observation of serum and salivary NLRP3 levels; Evaluation of serum and salivary NLRP3 levels
Periodontitis + diabetes Evaluation of serum and salivary NLRP3	Other: Observation of serum and salivary NLRP3 levels; Evaluation of serum and salivary NLRP3 levels

Outcome Measures

Primary Outcome Measures

1. Clinical attachment level [1-year]

   evaluation of changes in clinical attachment level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Messina	Messina		Italy	98100

Sponsors and Collaborators

• University of Messina

Investigators

• Study Chair: Giovanni Matarese, University of Messina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gaetano Isola, DDS, PhD, Researcher, University of Messina
• ClinicalTrials.gov Identifier: NCT04450810
• Other Study ID Numbers: 23-18
• First Posted: Jun 30, 2020
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis; Periodontal Diseases; Metabolic Diseases

Study Results

No Results Posted as of Jan 26, 2021