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OpenTrials
Completed

NCT Number: NCT04450810

Role of NLRP3 in Periodontitis and Diabetes

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.

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Key information

Conditions

Metabolic Disease Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Stomatognathic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Messina

Messina, 98100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observation of serum and salivary NLRP3 levels

Other

Evaluation of serum and salivary NLRP3 levels

Primary outcomes

  1. Clinical attachment level

    Time frame: 1-year

    evaluation of changes in clinical attachment level

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

Evaluation of Serum and Salivary NLRP3 in Periodontitis and Diabetes Patients

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2020
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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