Dental Anxiety Clinical Trial
— OPI2Official title:
Salivary Immune/Stress Biomarkers Among Children
NCT number | NCT05021380 |
Other study ID # | PUMS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2021 |
Est. completion date | June 30, 2022 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Poznan University of Medical Sciences | Poznan |
Lead Sponsor | Collaborator |
---|---|
Poznan University of Medical Sciences | University Paris 7 - Denis Diderot |
Poland,
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
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 |
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