Study Results
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Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2021-08-01
2022-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
12 Years
ALL
Yes
Sponsors
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University Paris 7 - Denis Diderot
OTHER
Poznan University of Medical Sciences
OTHER
Responsible Party
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Elzbieta Paszynska
Assoc. Prof.
Principal Investigators
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Elzbieta Paszynska, Prof
Role: PRINCIPAL_INVESTIGATOR
Poznan University of Medical Sciences, Poland
Yves Boucher, Prof
Role: STUDY_CHAIR
Université de Paris & Groupe Hospitalier Pitié Salpêtrière, 75006 Paris, France
Locations
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Poznan University of Medical Sciences
Poznan, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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PUMS
Identifier Type: -
Identifier Source: org_study_id
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