Stress, EmotionalOPI2NCT05021380
Salivary Immune/Stress Biomarkers Among Children
An observational study of Stress, Emotional and Dental Anxiety, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotional, Dental Anxiety, Dental Pain and Sensation Disorder
- What is being tested?
- GROUP
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2021to 30 Jun 2022
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 60-812
Elzbieta Paszynska, Prof, +48618547027, paszynska@ump.edu.pl
Monika Dmitrzak-Weglarz, Prof, +48618547027, mweglarz@ump.edu.pl
About this study
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.
Read the 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.
- Conditions
- Stress, Emotional, Dental Anxiety, Dental Pain and Sensation Disorder, Cortisol; Hypersecretion
- Being tested
- GROUP
- Keywords
- saliva, biomarkers, cortisol, IgA, IgG, IgM, amylase, opiorphin
- Medical subject headings
- Stress, Psychological, Toothache, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GROUPOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental pain
Proportion of subjects showing no increase in dental pain
Measured: 30 days
salivary biomarkers
Proportion of subjects showing no increase in salivary biomarkers
Measured: 30 days
dental anxiety
Proportion of subjects showing no increase in stress perception
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Aug 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress, EmotionalStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University Paris 7 - Denis Diderot
- Responsible party
- Principal investigator, Elzbieta Paszynska, Poznan University of Medical Sciences
- Investigators
- Elzbieta Paszynska, Prof, Principal investigator, Poznan University of Medical Sciences, PolandYves Boucher, Prof, Study chair, Université de Paris & Groupe Hospitalier Pitié Salpêtrière, 75006 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021380
- Sponsor's protocol ID
- PUMS
- Acronym
- OPI2
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we do not plan any individual participant data available share to other researchers
Publications
Paszynska E, Roszak M, Slopien A, Boucher Y, Dutkiewicz A, Tyszkiewicz-Nwafor M, Gawriolek M, Otulakowska-Skrzynska J, Rzatowski S, Dmitrzak-Weglarz M. Is there a link between stress and immune biomarkers and salivary opiorphin in patients with a restrictive-type of anorexia nervosa? World J Biol Psychiatry. 2020 Mar;21(3):220-229. doi: 10.1080/15622975.2019.1593502. Epub 2019 Apr 23.
PubMed 30880537Boucher Y, Braud A, Dufour E, Agbo-Godeau S, Baaroun V, Descroix V, Guinnepain MT, Ungeheuer MN, Ottone C, Rougeot C. Opiorphin levels in fluids of burning mouth syndrome patients: a case-control study. Clin Oral Investig. 2017 Sep;21(7):2157-2164. doi: 10.1007/s00784-016-1991-0. Epub 2016 Nov 10.
PubMed 27834029Slavish DC, Szabo YZ. The effect of acute stress on salivary markers of inflammation: a systematic review protocol. Syst Rev. 2019 May 2;8(1):108. doi: 10.1186/s13643-019-1026-4.
PubMed 31046830
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Immune/Stress Biomarkers Among Children
- ClinicalTrials.gov ID
- NCT05021380
- Acronym / sponsor ID
- OPI2 / PUMS
- Conditions
- Stress, Emotional, Dental Anxiety, Dental Pain and Sensation Disorder, Cortisol; Hypersecretion
- Keywords
- saliva, biomarkers, cortisol, IgA, IgG, IgM, amylase, opiorphin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- University Paris 7 - Denis Diderot
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 25 Aug 2021 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Other: GROUP50 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| GROUPNon-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 | Other | Group |
Primary outcome
dental pain
Time frame: 30 days
Proportion of subjects showing no increase in dental pain
salivary biomarkers
Time frame: 30 days
Proportion of subjects showing no increase in salivary biomarkers
dental anxiety
Time frame: 30 days
Proportion of subjects showing no increase in stress perception
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Background: PubMed 30880537Paszynska E, Roszak M, Slopien A, Boucher Y, Dutkiewicz A, Tyszkiewicz-Nwafor M, Gawriolek M, Otulakowska-Skrzynska J, Rzatowski S, Dmitrzak-Weglarz M. Is there a link between stress and immune biomarkers and salivary opiorphin in patients with a restrictive-type of anorexia nervosa? World J Biol Psychiatry. 2020 Mar;21(3):220-229. doi: 10.1080/15622975.2019.1593502. Epub 2019 Apr 23.
- Background: PubMed 27834029Boucher Y, Braud A, Dufour E, Agbo-Godeau S, Baaroun V, Descroix V, Guinnepain MT, Ungeheuer MN, Ottone C, Rougeot C. Opiorphin levels in fluids of burning mouth syndrome patients: a case-control study. Clin Oral Investig. 2017 Sep;21(7):2157-2164. doi: 10.1007/s00784-016-1991-0. Epub 2016 Nov 10.
- Results publication: PubMed 31046830Slavish DC, Szabo YZ. The effect of acute stress on salivary markers of inflammation: a systematic review protocol. Syst Rev. 2019 May 2;8(1):108. doi: 10.1186/s13643-019-1026-4.
- Individual participant dataSharing planned: No. we do not plan any individual participant data available share to other researchers
Related trials for Stress, Emotional
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Recruiting
Trauma-Informed Yoga Intervention in Young Women
Trauma, Young Adult Females
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.
Elzbieta Paszynska, Prof principal investigator
Poznan University of Medical Sciences, Poland
Yves Boucher, Prof study chair
Université de Paris & Groupe Hospitalier Pitié Salpêtrière, 75006 Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Emotional and Dental Anxiety, run by Poznan University of Medical Sciences at 1 site in Poland.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Aug 2021. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elzbieta Paszynska, Prof (48618547027, paszynska@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dental pain (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05021380, which also lists 3 linked publications.
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 25 Aug 2021.