Allostatic Load Assessment Using Hair Cortisol and Dehydr... | NCT07443605

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

NCT07443605

Sponsor

University of Trieste

Status

Completed

Last Update Posted

Mar 4, 2026Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

Stress Disorders

Interventions

stressed periodontal patients

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Jun 30, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Feb 24, 2026

First Submission Date that Met QC Criteria

Feb 24, 2026

First Posted Date

Mar 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2026

Last Update Posted Date

Mar 4, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bevilacqua Lorenzo, DDS, Msc Clinical Department of Medical Sciences, Surgery and Healt, University of Trieste, Trieste, Italy, University of TriestePrincipal Investigator

Lead Sponsor

University of TriesteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hair markers levels in stressed periodontal patients	Other		Diagnostic Test: stressed periodontal patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stressed periodontal patients	Diagnostic 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cortisol and dehydroepiandrosterone sulfate	cortisol (pg/mg) and dehydroepiandrosterone Sulfate (pg/mg) present in the hair of periodontal patients	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Trieste		Trieste	TS	34125	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D040921	Stress Disorders, Traumatic
D010518	Periodontitis

Ancestor Terms

ID	Term
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders
D010510	Periodontal Diseases
D009059	Mouth Diseases

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Browse Branches

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