Role of NLRP3 in Periodontitis and Diabetes

Periodontal Diseases Clinical Trial

Official title:

Evaluation of Serum and Salivary NLRP3 in Periodontitis and Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450810
• Other study ID #: 23-18
• Status: Completed
• Start date: June 1, 2014
• Est. completion date: September 30, 2017

Study information

• Verified date: January 2021
• Source: University of Messina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 30, 2017
• Est. primary completion date: September 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Periodontal Diseases
• Periodontitis

Intervention

Other:
• Observation of serum and salivary NLRP3 levels
Evaluation of serum and salivary NLRP3 levels

Locations

Country	Name	City	State
Italy	University of Messina	Messina

Sponsors (1)

Lead Sponsor	Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level	evaluation of changes in clinical attachment level	1-year