臨床研究等提出・公開システム

Date of registration	June. 17, 2024
Last modified on	June. 17, 2024
Trial ID	jRCT1041240048

Scientific Title	Clinical Study on the Efficacy of Alternative Methods of Surface Anesthesia during Infiltration Anesthesia
Public Title	Research on alternative surface anesthesia methods to conventional surface anesthesia agents

Contact for Scientific Queries	Name	Saitoh Issei
	Affiliation	Asahi University
	Address	Gifu Mizuho city Hozumi 1851
	Telephone	+81-58-329-1130
	E-mail	isaitoh@dent.asahi-u.ac.jp
Contact for Public Queries	Name	Ibano Natsumi
	Affiliation	Asahi University
	Address	Gifu Mizuho city Hozumi 1851
	Telephone	+81-58-329-1130
	E-mail	bano@dent.asahi-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 17, 2024
Target sample size		80
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	placebo control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Adults 18 years of age or older with no history of allergy to infiltration anesthetics who require infiltration anesthesia for dental treatment at Asahi University Medical and Dental Center Pediatric Dentistry and Nanairo no Mori Dental Clinic.
	Exclusion Criteria	Persons with a history of allergy to infiltration anesthetics
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Diseases requiring dental procedures requiring local anesthesia (dental caries, periodontal disease)
Intervention(s)		A cotton ball soaked with the surface anesthetic is placed in the gingivobuccal transition area for 1 minute, followed by infiltration anesthesia using a 31G infiltration needle and a Xylocaine Cartridge in accordance with the usual method. For the alternative method of surface anesthesia, a cotton swab (approximately 5 mm in diameter) is pressed against the puncture point with approximately 200 g of pressure (each time calibrated with a scale) for 1 minute, followed by infiltration anesthesia using a 31 G immersion needle and Xylocaine Cartridge, according to the usual method. In the surface anesthetic and alternative surface anesthesia group, pressure is applied to the puncture point with the tip of a cotton swab soaked in surface anesthetic at a pressure of approximately 200 g for 1 minute, followed by infiltration anesthesia. In the placebo group, a cotton ball is placed in the gingivobuccal transition area for 1 minute using Vaseline (0.5 g), followed by infiltration anesthesia.
Health Condition(s) Keyword		oral and jaw disease
Health Condition(s) Code		C07
Primary Outcome(s)		Pain will be assessed using the Visual Analogue Scale (VAS) to evaluate the effectiveness of alternative methods of surface anesthesia.
Secondary Outcome(s)		The Face Anxiety Scale (FAS) will be used to assess anxiety during infiltration anesthesia, and the differences between conventional and alternative surface anesthesia methods will be discussed.

Primary Sponsor	Azuma Keito

Primary Sponsor	Azuma Keito

Secondary Sponsor

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Asahi University Ethics Review Committee
Address	Mizuho city Hozumi 1851, Gifu
Date of approval	May. 22, 2024

Plan to share IPD	Yes

Countries of Recruitment（Except Japan）	none