Metabolic DiseaseNCT04450810
Role of NLRP3 in Periodontitis and Diabetes
An observational study of Metabolic Disease and Periodontal Diseases, run by University of Messina at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Periodontal Diseases
- What is being tested?
- Observation of serum and salivary NLRP3 levels
- How many people
- 133 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2014to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy controls (n=32), periodontitis (n=34), diabetes (n=33), and a combination of periodontitis + diabetes (n=34)
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Serum and Salivary NLRP3 in Periodontitis and Diabetes Patients
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.
Read the 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.
- Conditions
- Metabolic Disease, Periodontal Diseases
- Being tested
- Observation of serum and salivary NLRP3 levels
- Medical subject headings
- Metabolic Diseases, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of serum and salivary NLRP3 levelsOther
Evaluation of serum and salivary NLRP3 levels
| Study group | Role | What they receive |
|---|---|---|
| Control | Evaluation of serum and salivary NLRP3 Receives: Other: Observation of serum and salivary NLRP3 levels | |
| Periodontitis | Evaluation of serum and salivary NLRP3 Receives: Other: Observation of serum and salivary NLRP3 levels | |
| Diabetes | Evaluation of serum and salivary NLRP3 Receives: Other: Observation of serum and salivary NLRP3 levels | |
| Periodontitis + diabetes | Evaluation of serum and salivary NLRP3 Receives: Other: Observation of serum and salivary NLRP3 levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level
evaluation of changes in clinical attachment level
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Jun 2014
- Primary completion18 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, DDS, PhD, University of Messina
- Investigators
- Giovanni Matarese, Study chair, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450810
- Sponsor's protocol ID
- 23-18
- Status last verified
- Jan 2021
- First submitted
- 24 Jun 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum and Salivary NLRP3 in Periodontitis and Diabetes Patients
- ClinicalTrials.gov ID
- NCT04450810
- Acronym / sponsor ID
- 23-18
- Conditions
- Metabolic Disease, Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Observation of serum and salivary NLRP3 levelsEvaluation of serum and salivary NLRP3 |
| Periodontitis | – | Other: Observation of serum and salivary NLRP3 levelsEvaluation of serum and salivary NLRP3 |
| Diabetes | – | Other: Observation of serum and salivary NLRP3 levelsEvaluation of serum and salivary NLRP3 |
| Periodontitis + diabetes | – | Other: Observation of serum and salivary NLRP3 levelsEvaluation of serum and salivary NLRP3 |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy controls (n=32), periodontitis (n=34), diabetes (n=33), and a combination of periodontitis + diabetes (n=34)
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of serum and salivary NLRP3 levelsEvaluation of serum and salivary NLRP3 levels | Other | Control, Diabetes, Periodontitis, Periodontitis + diabetes |
Primary outcome
Clinical attachment level
Time frame: 1-year
evaluation of changes in clinical attachment level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Matarese study chair
University of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disease and Periodontal Diseases, run by University of Messina at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.