Salivary Immune/Stress Biomarkers Among Children (OPI2)

August 19, 2021 updated by: Elzbieta Paszynska, Poznan University of Medical Sciences

Background: The use of easily accessible biomarkers for assessing young patients' health is important. This study's aim is a measuring stress/immune biomarkers in saliva of healthy school-age children and compare subgroups according to age, sex, stress perception in dental pain related to symptomatic irreversible pulpitis (SIP) and symptomatic apical periodontitis (SAP).

Material and methods: 50 children diagnosed with SIP and SAP aged from 6 to 12 years old will be treated with root canal treatment. Dental examination using DMF score and oral hygiene level will be performedby experienced dentists. Salivary samples will be collected three times: before treatment in day of first dental visit (1), after two weeks (2), and after next two weeks = 30 days (3). Additionally, pain and stress perception will be examined by VAS scale and questionnaires dedicated for children anxiety: Frankl behavior rating scale, Venham's anxiety and behavior rating scale. Salivary immunoglobullins A, G, M, opiorphin, free cortisol and amylase will be measured using commercially available ELISA kits. Results will assess which of the measured salivary biomarkers is related to stress and dental pain, suggesting its use for evaluating in non-invasive way in childhood.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Psychological stress impairs homeostasis in many aspects, including immune dysregulation with important variability according to age and sex. Use of easily accessible biomarkers is of importance to assess these changes in fragile subjects, as for example children, especially in a context of exposure to childhood stress experience, when invasive sampling procedures may increase the psychic stress.

Saliva is a promising tool which has been used both for acute and chronic stress Several salivary immune biomarkers are now considered to be sensitive and reliable readouts of mental stress in adult patients, among them free cortisol, alpha-amylase (sAA) and secretory immunoglobulin IgA (sIgA), IgM, IgG and opiorphin (OPI).

These four biomarkers may be measured easily in saliva, but in variable amounts according to age and sex, as well as in response to psychological stress. The main objective of this exploratory study was therefore to compare salivary levels of opiorphin, cortisol, sAA, sIgA, IgM, IgG in two groups of healthy children, 6-12 years old, a developmental age critical to mental disorders and dental interventional treatment, with ELISA tests.

This study's aim is a measuring stress/immune biomarkers in saliva of healthy school-age children and compare subgroups according to age, sex, stress perception in dental pain related to symptomatic irreversible pulpitis (SIP) and symptomatic apical periodontitis (SAP).

Material and methods: 50 children diagnosed with SIP and SAP aged from 6 to 12 years old will be treated with root canal treatment. Dental examination using DMF score and oral hygiene level will be performedby experienced dentists. Salivary samples will be collected three times: before treatment in day of first dental visit (1), after two weeks (2), and after next two weeks = 30 days (3). Additionally, pain and stress perception will be examined by VAS scale and questionnaires dedicated for children anxiety: Frankl behavior rating scale, Venham's anxiety and behavior rating scale. Salivary immunoglobullins A, G, M, opiorphin, free cortisol and amylase will be measured using commercially available ELISA kits. Results will assess which of the measured salivary biomarkers is related to stress and dental pain, suggesting its use for evaluating in non-invasive way in childhood.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Anna Krahel, DDS
  • Phone Number: 48618547027
  • Email: a.krahel@wp.pl

Study Locations

  • Poland
      • Poznań, Poland, 60-812
        • Recruiting
        • Poznan University of Medical Sciences
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Anna Krahel, DDS
        • Principal Investigator:
          • Yves Boucher, Prof

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

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited at University dental clinic in Child and Adolescent Section, one experienced dentist will conduct all dental and salivary collection procedures.

Description

Inclusion Criteria:

  • male or female
  • age 6 - 12 y.o.
  • complaint dental pain
  • diagnosis of symptomatic irreversible pulpitis or symptomatic apical periodontitis
  • assigned agreement to the informed consent form by parents/caregivers and children cooperation

Exclusion Criteria:

  • use of analgesics or antibiotics prior 48 h before specimen collection
  • having a systemic disease
  • disorders interfering with salivary function or flow
  • regular medication intake interfering with salivary function or flow
  • having temporary infectious disease
  • having neurodevelopmental dysfunction (e.g ADHD)
  • lack of cooperation during dental visits
  • inability to understand the content of the informed consent form by parents/caregivers and children

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group
50 generally healthy children diagnosed with dental pain as symptomatic irreversible pulpitis (SIP) or symptomatic apical periodontitis (SAP) aged from 6 to 12 years old will be included to the GROUP.
Other: GROUP
Non-invasive diagnosis of dental pain, dental root canal treatment, salivary specimen collection from the first visit to next and the last during 4 weeks of dental care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dental pain
Time Frame: 30 days
Proportion of subjects showing no increase in dental pain
30 days
salivary biomarkers
Time Frame: 30 days
Proportion of subjects showing no increase in salivary biomarkers
30 days
dental anxiety
Time Frame: 30 days
Proportion of subjects showing no increase in stress perception
30 days

Collaborators and Investigators

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

Sponsor

Poznan University of Medical Sciences

Collaborators

University Paris 7 - Denis Diderot

Investigators

  • Principal Investigator: Elzbieta Paszynska, Prof, Poznan University of Medical Sciences, Poland
  • Study Chair: Yves Boucher, Prof, Université de Paris & Groupe Hospitalier Pitié Salpêtrière, 75006 Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2021

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

we do not plan any individual participant data available share to other researchers

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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