- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443605
Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease
Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease.
This study was designed with a double-blind observation design on a population of patients with different periodontal conditions.
The aim is to assess the influence of allostatic loading through the dosage of cortisol, DHEA, DHEAS in both periodontitis pathogenesis and non-surgical periodontal treatment.
The NNT will be built on the biases related to the pathologies in existence. The indicative number of patients is around 100 units and samples will be taken at t0 (baseline, dental visit with periodontal evaluation) and t60 (60 days after non-surgical periodontal treatment). For this study there is no randomization of groups, the dental treatments that will be performed will be in the usual clinical practice and will not be in any way influenced by the objectives of the study.
MATERIALS AND METHODS:
At baseline, the periodontal chart will be performed, a SVS (Stress-Related Vulnerability Scale) test questionnaire will be taken and biological markers will be evaluated by taking a small strand of hair. The same revaluations will also be carried out at 60 days.
Patients will also be recruited according to an information system, training and will be given a paper informed consent in accordance with the current legislation which is attached.
The sample once taken will be kept at the health facility until the analysis of the sample and the results will then be communicated to the patient within 30 days.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
TS
-
Trieste, TS, Italy, 34125
- University of Trieste
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Periodontitis stages III or IV
Exclusion Criteria:
< 18 years or > 70 years pregnant or lactating females Periodontal treatment in the previous 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Hair markers levels in stressed periodontal patients
|
A hair strand of about 3 mm in diameter was collected from all the patients, cut at the scalp in the position of the posterior vertex and the nuchal area of the patient enrolled so as not to change or alter the aesthetic appearance a significant levy.
The proximal hair segment of 1 cm was used for analysis.
The average hair growth rate of 1 cm/month represents the catabolism of cortisol and dehydroepiandrosterone sulfate (DHEAS) in the hair, in the month preceding the periodontal evaluation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cortisol and dehydroepiandrosterone sulfate
Time Frame: 3 months
|
cortisol (pg/mg) and dehydroepiandrosterone Sulfate (pg/mg) present in the hair of periodontal patients
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- BLorenzo1
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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