- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536204
Characterization of JAK1 and JAK2 Activation in Gingival Tissues During Homeostasis and Periodontitis
Unraveling the Role of JAK1 and JAK2 Pathway in Periodontitis: Drivers of Immunopathology and Possible Therapeutic Targets
The goal of this observational study is to examine JAK1/2 pathway activation in gingival tissues from adults with healthy gingiva and those with inflamed gingiva (periodontitis). The main question it aims to answer is:
Is the JAK1/2 pathway overactivated in periodontitis compared to health?
Participants with healthy gingiva and periodontitis will donate gingival tissue to study the JAK1/2 pathway. All participants wil receive diagnosis and treatment of the gingival condition.
Study Overview
Status
Detailed Description
The goal of this observational study is to examine JAK1/2 pathway activation in gingival tissues from adults with healthy gingiva and those with inflamed gingiva (periodontitis). The main question it aims to answer is:
Is the JAK1/2 pathway overactivated in periodontitis compared to health?
A secondary outcome will be to describe the histological areas, such as epithelium or lamina propria, where the JAK1/2 pathway will be activated including the different subpopulation of cells.
The protocol include one visit where the gingival biopsies are taken.
Participants with healthy gingiva and periodontitis will donate gingival tissue to study the JAK1/2 pathway. All participants will receive diagnosis and treatment of the gingival condition.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nicolas Dutzan, DDS, PhD
- Phone Number: +56934037995
- Email: ndutzan@uchile.cl
Study Locations
-
-
Metropolitan Region
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Santiago, Metropolitan Region, Chile
- Recruiting
- Faculty of Dentistry, University of Chile
-
Contact:
- Nicolas Dutzan, DDS, PhD
- Phone Number: +56934037995
- Email: ndutzan@uchile.cl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults
- Sistemically healthy
Exclusion Criteria:
- Active Maliganancy
- History of radiation to the head-neck region
- Chemotherapy or radiation within the last 5 years
- History of hepatitis B/C or HIV infection
- Autoimmune diseases
- Diagnosis of diabetes
- Pregnancy or lactation
- More than 3 hospitalizations over the last 3 years
- Use of systemic antibiotics over the last 3 months
- Use of systemic corticosteroids or immunosuppressants over the last 3 months
- Use of cytokine therapy over the last 3 months
- Use of large doses of pre/probiotic supplements over the last 3 months
- Smoke more than 10 cigarettes per day
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Healthy gingiva
Adults without gingival inflammation diagnosed by a clinical exam
|
|
Periodontits
Adults with periodontitis diagnosed by a clinical exam
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
JAK1/2 pathway activation in gingival tissues
Time Frame: Day 1
|
The activation of the JAK1/2 pathway will be evaluated by the phophorilation of JAK1/2 in the gingival tissues determined by western blot. Patients will be categorizied as 0, 1, 2. 0 = no phosphorilation
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/11
- 1231350 (Other Grant/Funding Number: FONDECYT-Research and Development National Agency from the Chilean Government)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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