Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 1:19 AM
Study NCT ID:
NCT07443605
Status:
COMPLETED
Last Update Posted:
2026-03-04
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease
Sponsor:
University of Trieste
Organization:
Study Overview
Official Title:
Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease.
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: