Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT06385314 - A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures
Completed NCT04308005 - Drawing as a Measurement of Dental Anxiety
Completed NCT01908127 - Efficacy of Film Modelling in Paediatric Dentistry N/A
Completed NCT00695630 - Flumazenil Reversal of Oral Triazolam Phase 1/Phase 2
Completed NCT05759286 - A Blend of Lavender-neroli Oils Aromatherapy and Music for Managing Anxiety in a Pediatric Patient N/A
Completed NCT04234737 - Efficacy of Hypnotherapy in Children With Dental Anxiety N/A
Completed NCT03838081 - Evaluation on the Anxiety of Third Molar Extraction N/A
Enrolling by invitation NCT06057090 - Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients? N/A
Not yet recruiting NCT04924452 - Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Patients N/A
Completed NCT03722771 - Influence of Lavender Oil on Vital Signs in Oral Surgery Patients N/A
Completed NCT03596255 - Clinical Estimation of Dental Anxiety
Completed NCT05038540 - The Effect of Virtual Reality Glasses on Dental Anxiety Control N/A
Completed NCT03324347 - Dog-Assisted Therapy in Dentistry N/A
Not yet recruiting NCT06139640 - The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children N/A
Completed NCT02591797 - Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children N/A
Completed NCT02588079 - Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety N/A
Not yet recruiting NCT00355693 - Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol in Anxious Patients Phase 4
Recruiting NCT06243705 - Effectiveness of Robot-pets in Reducing Dental Anxiety in Children N/A
Recruiting NCT06058533 - Pre-Visit Positive Imagery in Reducing Dental Anxiety N/A
Completed NCT03993080 - Virtual Reality Relaxation to Decrease Dental Anxiety N/A