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NCT05021380: OPI2
Salivary Immune/Stress Biomarkers Among Children
trial testing GROUP in Stress, Emotional in 50 participants. Status unknown.
30 March 2022
Quick facts
| Lead sponsor | Poznan University of Medical Sciences |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 1 August 2021 |
| Primary completion | 30 March 2022 |
| Estimated completion | 30 June 2022 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- GROUP
Conditions studied
- Stress, Emotional — all drugs for Stress, Emotional →
- Dental Anxiety — all drugs for Dental Anxiety →
- Dental Pain and Sensation Disorder — all drugs for Dental Pain and Sensation Disorder →
- Cortisol; Hypersecretion — all drugs for Cortisol; Hypersecretion →
Sponsor
Poznan University of Medical Sciences
Who can join
Adults 6 to 12, any sex, with Stress, Emotional or Dental Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05021380
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05021380 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Poznan University of Medical Sciences
- Last refreshed: 25 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05021380.
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