The effectiveness of alternatives for surface anesthesia

JRCT ID: jRCT1041240147

Registered date:17/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Tooth decay
• Date of first enrollment: 22/05/2024
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Although surface anesthesia is usually used as a pretreatment for infiltration anesthesia, there are often problems with behavioral management in children with high saliva production, as the surface anesthetic mixes with the saliva and spreads around the mouth, causing the child to become uncooperative due to the uncomfortable feeling, or to become uncooperative when they detect the flavor of the surface anesthetic, as they have had previous experiences of painful infiltration anesthesia. For this reason, in recent years, alternative methods that do not use surface anesthesia have been investigated. In this study, we will investigate the effectiveness of a new surface anesthesia alternative method compared to the conventional surface anesthesia method during infiltration anesthesia in adults who can accurately evaluate pain.
A surface anesthetic was used in the gel form (20% lidocaine gel, banana flavor, Hakusui Boeki Co., Ltd.) (0.5g), and a cotton ball soaked in the surface anesthetic was placed in the gingival-buccal transition area for 1 minute. After that, infiltration anesthesia was performed using a 31G infiltration needle and Xylocaine Cartridge according to the usual method. For the surface anesthesia alternative method, a cotton swab (approx. 5 mm in diameter) is pressed into the injection site for 1 minute at a pressure of approximately 200 g (the pressure is calibrated using a measuring device each time), and then infiltration anesthesia is performed using a 31G infiltration needle and Xylocaine Cartridge according to the usual method. In the surface anesthetic and surface anesthetic alternative groups, the tip of a cotton swab soaked in surface anesthetic is pressed into the injection site for one minute at a pressure of approximately 200 g, and then infiltration anesthesia is administered. In the placebo group, a cotton ball is placed on the gingival-buccal transition area for one minute using Vaseline (0.5 g), and then infiltration anesthesia is administered.

Outcome(s)

• Primary Outcome: The effectiveness of the surface anesthesia alternative method will be examined using a visual analogue scale (VAS) to determine pain levels. The difference between the conventional surface anesthesia method and the surface anesthesia alternative method will be examined using the Face Anxiety Scale (FAS) to determine anxiety levels during infiltration anesthesia.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Adults aged 18 and over
• Exclude criteria: History with allergy to local anesthetics

Related Information

• Primary Sponsor: Saitoh Issei