The Effect of Er,Cr:YSGG Laser-assisted Topical Anesthetic on Oral Mucosal Anesthesia

NCT07169032 | Completed Early Phase 1 Results FDA Drug FDA Device

• 1 other identifier: JNUKY-2023-0149
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests whether using an Er,Cr:YSGG laser before applying numbing gel (lidocaine) can help reduce pain during dental procedures compared to traditional methods. Investigators want to know: Does the laser make the numbing gel work better and longer? Does it lower pain and keep patients calmer (measured by heart rate)? Investigators enrolled 20 adults (10 men, 10 women) and assigned them to three groups: Laser + Numbing Gel: Laser was used on the gums before applying lidocaine. Sham Laser + Numbing Gel: A fake laser was used with lidocaine. Sham Laser + Vaseline: A fake laser was used with Vaseline (no numbing effect). Participants reported pain levels on a scale (0=no pain, 10=worst pain) when a tiny needle touched their gums. Investigators also checked their heart rate.

Conditions

Anesthesia

Keywords

Er,Cr:YSGG laser; needle-free anesthesia; dental anxiety; oral mucosal anesthesia

Outcome Measures

Primary Outcomes (5)

• Insertion Depth at Initial Sensory Detection

  Insert a sterile needle into the mucosa at the sites. Record the Insertion depth when participants perceived an "initial sensory detection"

  10, 20, 30, 40, and 50 minutes

• Insertion Depth at Pain

  Insert a sterile needle into the mucosa at the sites. Record the Insertion depth when participants felt "pain".

  10, 20, 30, 40, and 50 minutes

• Pain Score at Initial Sensory Detection

  Insert a sterile needle into the mucosa at the sites. Record the pain score when participants perceived an "initial sensory detection". Evaluated with a linear visual analog scale. "0" represents no pain, and "10" represents the most intense pain imaginable.

  10, 20, 30, 40, and 50 minutes

• Pain Score at Pain

  Insert a sterile needle into the mucosa at the sites. Record the pain score when participants felt "pain". Evaluated with a linear visual analog scale. "0" represents no pain, and "10" represents the most intense pain imaginable.

  10, 20, 30, 40, and 50 minutes

• Heart Rate

  Insert a sterile needle into the mucosa at the sites. Record the heart rate with an electrocardiogram monitor when participants felt "pain".

  10, 20, 30, 40, and 50 minutes

Study Arms (3)

Laser + Lidocaine

EXPERIMENTAL

One of three sites in the vestibular groove of the mandibular anterior teeth region of each participant received irradiation with a 2780 nm, 1.0 W Er,Cr:YSGG laser for 1 minute followed by application of 2% lidocaine gel.

Device: Er,Cr:YSGG laser irradiation; Drug: Lidocaine

Sham Laser + Lidocaine

SHAM COMPARATOR

One of three sites in the vestibular groove of the mandibular anterior teeth region of each participant received sham laser irradiation for 1 minute followed by application of 2% lidocaine gel.

Drug: Sham Laser irradiation; Drug: Lidocaine

Sham Laser + Vaseline

PLACEBO COMPARATOR

One of three sites in the vestibular groove of the mandibular anterior teeth region of each participant received sham laser irradiation for 1 minute followed by application of Vaseline.

Drug: Sham Laser irradiation; Drug: Vaseline

Interventions

Er,Cr:YSGG laser irradiation DEVICE

irradiation with a 2780 nm, 1.0 W Er,Cr:YSGG laser for 1 minute

Laser + Lidocaine

Sham Laser irradiation DRUG

sham laser irradiation for 1 minute

Sham Laser + Lidocaine; Sham Laser + Vaseline

Lidocaine DRUG

2% lidocaine gel

Laser + Lidocaine; Sham Laser + Lidocaine

Vaseline DRUG

Vaseline

Sham Laser + Vaseline

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• could understand and follow given instructions

You may not qualify if:

• excessive dental anxiety
• anesthesia allergies
• mucosal lesions
• cardiovascular disease
• diabetes
• pregnancy or lactation
• severe psychiatric disorders
• hearing abnormalities
• speech dysfunction

Sponsors & Collaborators

• Li Zhen Zhong: lead

Study Sites (1)

the First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• Khalighi HR, Mojahedi M, Parandoosh A. Efficacy of Er,Cr:YSGG laser-assisted delivery of topical anesthesia in the oral mucosa. Clin Oral Investig. 2021 Mar;25(3):1055-1058. doi: 10.1007/s00784-020-03399-x. Epub 2020 Jun 18.

  PMID: 32556664 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Petrolatum

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydrocarbons

Results Point of Contact

• Title: LI ZHEN ZHONG
• Organization: First Affiliated Hospital of Jinan University

nicolezlz@foxmail.com

+8613711706774

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master Student

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: January 1, 2024
• Primary Completion: February 20, 2024
• Study Completion: February 21, 2024
• Last Updated: December 4, 2025
• Results First Posted: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)