Salivary Immune/Stress Biomarkers Among Children

NCT05021380 | Unknown

• 1 other identifier: PUMS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

saliva; biomarkers; cortisol; IgA; IgG; IgM; amylase; opiorphin

Outcome Measures

Primary Outcomes (3)

• dental pain

  Proportion of subjects showing no increase in dental pain

  30 days

• salivary biomarkers

  Proportion of subjects showing no increase in salivary biomarkers

  30 days

• dental anxiety

  Proportion of subjects showing no increase in stress perception

  30 days

Study Arms (1)

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

Interventions

GROUP OTHER

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

Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead
• University Paris 7 - Denis Diderot: collaborator

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 60-812, Poland

RECRUITING

Related Publications (3)

• 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.

  PMID: 30880537 BACKGROUND

• 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.

  PMID: 27834029 BACKGROUND

• 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.

  PMID: 31046830 RESULT

MeSH Terms

Conditions

Stress, Psychological; Toothache; Sensation Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• Elzbieta Paszynska, Prof

  Poznan University of Medical Sciences, Poland

  PRINCIPAL INVESTIGATOR

• Yves Boucher, Prof

  Université de Paris & Groupe Hospitalier Pitié Salpêtrière, 75006 Paris, France

  STUDY CHAIR

Central Study Contacts

Elzbieta Paszynska, Prof

CONTACT

48618547027; paszynska@ump.edu.pl

Anna Krahel, DDS

CONTACT

48618547027; a.krahel@wp.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: August 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)