Stress DisordersNCT07443605
Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease
A study testing stressed periodontal patients in people with Stress Disorders, run by University of Trieste at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stress Disorders
- What is being tested?
- stressed periodontal patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontitis stages III or IV
Who cannot join
- < 18 years or > 70 years pregnant or lactating females Periodontal treatment in the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Stress Disorders
- Being tested
- stressed periodontal patients
- Keywords
- CORTISOL, HAIR, STRESS, PERIODONTITIS, DEHYDROEPIANDROSTERONE SULFATE
- Medical subject headings
- Stress Disorders, Traumatic, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stressed periodontal patientsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Hair markers levels in stressed periodontal patients | Other | Not described Receives: Diagnostic Test: stressed periodontal patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
cortisol and dehydroepiandrosterone sulfate
cortisol (pg/mg) and dehydroepiandrosterone Sulfate (pg/mg) present in the hair of periodontal patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Sep 2021
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bevilacqua Lorenzo, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443605
- Sponsor's protocol ID
- BLorenzo1
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease.
- ClinicalTrials.gov ID
- NCT07443605
- Acronym / sponsor ID
- BLorenzo1
- Conditions
- Stress Disorders
- Keywords
- CORTISOL, HAIR, STRESS, PERIODONTITIS, DEHYDROEPIANDROSTERONE SULFATE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hair markers levels in stressed periodontal patients | Other | Diagnostic Test: stressed periodontal patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Periodontitis stages III or IV
Key exclusion criteria (1 listed)
- < 18 years or > 70 years pregnant or lactating females Periodontal treatment in the previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stressed 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. | Diagnostic test | Hair markers levels in stressed periodontal patients |
Primary outcome
cortisol and dehydroepiandrosterone sulfate
Time frame: 3 months
cortisol (pg/mg) and dehydroepiandrosterone Sulfate (pg/mg) present in the hair of periodontal patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stressed periodontal patients in people with Stress Disorders, run by University of Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cortisol and dehydroepiandrosterone sulfate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.