Clinical Trials Directory

Trials / Completed

CompletedNCT07443605

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
University of Trieste · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTstressed periodontal patientsA 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.

Timeline

Start date
2021-09-01
Primary completion
2024-06-30
Completion
2024-12-31
First posted
2026-03-02
Last updated
2026-03-04

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT07443605. Inclusion in this directory is not an endorsement.