Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062378) titled 'A study of subjective and physiological responses to dental-related olfactory stimuli' on July 28.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Nippon Dental university
Condition:
Condition - Not applicable (healthy adults with previous dental treatment experience). Dental fear severity will be assessed using the Dental Fear Survey.
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To determine whether subjective emotional ratings of dental-related olfactory stimuli differ according to the severity of dental fear.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Participants will be exposed to a predefined set of dental-related, pleasant, unpleasant, and control olfactory stimuli. Dental-related stimuli include eugenol, guaiacol, resin monomer, and sodium hypochlorite. Pleasant stimuli will include selected aroma, and unpleasant stimuli will include skatole and isovaleric acid. Distilled water or an equivalent minimally odorous stimulus will be used as the control. Each odor will generally be presented for approximately 10 seconds, with an adequate inter-stimulus rest interval. Subjective ratings will be obtained immediately after each presentation, and heart rate and electrodermal activity will be recorded continuously before, during, and after odor presentation.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1) Aged 18-59 years at the time of consent; 2) a healthy adult with previous dental treatment experience; and 3) able to understand the study and provide voluntary written informed consent.
Key exclusion criteria - 1) Chronic sinusitis, allergic rhinitis, common cold, or another condition affecting olfactory function; 2) use of medication that may affect olfactory, central nervous, or autonomic function; 3) current pharmacological or other treatment that suppresses dental fear; 4) a history of psychiatric disorders; or 5) judged unsuitable by the principal investigator for reasons of safety or data quality.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 06 Day
Date of IRB - 2026 Year 03 Month 23 Day
Anticipated trial start date - 2026 Year 07 Month 30 Day
Last follow-up date - 2026 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071386
Disclaimer: Curated by HT Syndication.