Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFirst Submitted
Initial submission to the registry
February 24, 2026
CompletedFirst Posted
Study publicly available on registry
March 2, 2026
CompletedMarch 4, 2026
March 1, 2026
2.8 years
February 24, 2026
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cortisol and dehydroepiandrosterone sulfate
cortisol (pg/mg) and dehydroepiandrosterone Sulfate (pg/mg) present in the hair of periodontal patients
3 months
Study Arms (1)
Hair markers levels in stressed periodontal patients
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- Periodontitis stages III or IV
You may not qualify if:
- \< 18 years or \> 70 years pregnant or lactating females Periodontal treatment in the previous 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Trieste
Trieste, TS, 34125, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS, Msc Clinical Department of Medical Sciences, Surgery and Healt, University of Trieste, Trieste, Italy
Study Record Dates
First Submitted
February 24, 2026
First Posted
March 2, 2026
Study Start
September 1, 2021
Primary Completion
June 30, 2024
Study Completion
December 31, 2024
Last Updated
March 4, 2026
Record last verified: 2026-03