Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease

March 2, 2026 updated by: Bevilacqua Lorenzo, University of Trieste

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • TS
      • Trieste, TS, Italy, 34125
        • University of Trieste

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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