PeriodontitisNCT05506098
Investigating STAT3 as a Driver of Pathology in Periodontitis
An observational study of Periodontitis, run by University of Chile at 1 site in Chile.
Trial summary
Periodontitis is a prevalent inflammatory condition that destroys tooth-supporting structures. This condition is associated with pro-inflammatory mediators that utilize STAT3 as an activator of specific genes related to inflammation and tissue destruction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- 28 participants
- Where
- 1 siteChile
- Study dates
- 20 Mar 2019to 20 Oct 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female and male adults living in Santiago, Chile.
Who may be able to join
- 18-year-old, in good general health, and had no significant medical history.
- no history of diabetes or other diseases different than periodontitis.
Who cannot join
- Pregnancy and lactation
- Use of antibiotics, immunosuppressive agents, or probiotics within 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating STAT3 as a Driver of Pathology and Potential Therapeutic Target in Periodontitis
Periodontitis is a prevalent inflammatory condition that destroys tooth-supporting structures. This condition is associated with pro-inflammatory mediators that utilize STAT3 as an activator of specific genes related to inflammation and tissue destruction. STAT3 has not been studied in the context of periodontitis in humans. We propose that STAT3 is associated with periodontitis. This knowledge might help to further our understanding of periodontitis pathology
- Conditions
- Periodontitis
- Being tested
- no intervention
- Keywords
- periodontitis, STAT3
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Subjects without periodontitis Receives: Other: no intervention | |
| Periodontitis | Subjects with periodontitis Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAT3 detection in gingival tissues
Detection of STAT3 in gingival tissues
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start20 Mar 2019
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Dutzan, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506098
- Sponsor's protocol ID
- 11180389
- Other IDs
- FONDECYT 11180389
- Status last verified
- Jan 2023
- First submitted
- 16 Aug 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data specified in the informed consent will be shared in publications
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating STAT3 as a Driver of Pathology and Potential Therapeutic Target in Periodontitis
- ClinicalTrials.gov ID
- NCT05506098
- Acronym / sponsor ID
- 11180389
- Conditions
- Periodontitis
- Keywords
- periodontitis, STAT3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 18 Aug 2022 (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.
Periodontitis is a prevalent inflammatory condition that destroys tooth-supporting structures. This condition is associated with pro-inflammatory mediators that utilize STAT3 as an activator of specific genes related to inflammation and tissue destruction. STAT3 has not been studied in the context of periodontitis in humans. We propose that STAT3 is associated with periodontitis. This knowledge might help to further our understanding of periodontitis pathology
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: no interventionSubjects without periodontitis |
| Periodontitis | – | Other: no interventionSubjects with periodontitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female and male adults living in Santiago, Chile.
Key inclusion criteria (2 listed)
- 18-year-old, in good general health, and had no significant medical history.
- no history of diabetes or other diseases different than periodontitis.
Key exclusion criteria (2 listed)
- Pregnancy and lactation
- Use of antibiotics, immunosuppressive agents, or probiotics within 3 months.
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 |
|---|---|---|
| no interventionno intervention | Other | Healthy, Periodontitis |
Primary outcome
STAT3 detection in gingival tissues
Time frame: 1 day
Detection of STAT3 in gingival tissues
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 30 Jan 2023.
- Individual participant dataSharing planned: Yes. All data specified in the informed consent will be shared in publications
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontitis, run by University of Chile at 1 site in Chile.
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 2 inclusion and 2 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 30 Jan 2023. 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 Chile. 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?
STAT3 detection in gingival tissues (time frame: 1 day). 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 30 Jan 2023.