Salivary Immune/Stress Biomarkers Among Children

Dental Anxiety Clinical Trial

— OPI2  

Official title:

Salivary Immune/Stress Biomarkers Among Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05021380
• Other study ID #: PUMS
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2021
• Source: Poznan University of Medical Sciences
• Contact: Elzbieta Paszynska, Prof
• Phone: 48618547027
• Email: paszynska[@]ump.edu.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cortisol; Hypersecretion
• Dental Anxiety
• Dental Pain and Sensation Disorder
• Sensation Disorders
• Stress, Emotional
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan

Sponsors (2)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences	University Paris 7 - Denis Diderot

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Boucher 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. — View Citation

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. — View Citation

Slavish 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dental pain	Proportion of subjects showing no increase in dental pain	30 days
Primary	salivary biomarkers	Proportion of subjects showing no increase in salivary biomarkers	30 days
Primary	dental anxiety	Proportion of subjects showing no increase in stress perception	30 days