NCT07443605

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

February 24, 2026

Last Update Submit

March 2, 2026

Conditions

Keywords

CORTISOLHAIRSTRESSPERIODONTITISDEHYDROEPIANDROSTERONE SULFATE

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

OTHER
Diagnostic Test: stressed periodontal patients

Interventions

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.

Hair markers levels in stressed periodontal patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Stress Disorders, TraumaticPeriodontitis

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

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

Locations