Early Phase 1
N=60
The Effect of Er,Cr:YSGG Laser-assisted Topical Anesthetic on Oral Mucosal Anesthesia
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT07169032 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Insertion Depth at Initial Sensory Detection — 7.75; 4.65; 0.4; 8.55 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Er,Cr:YSGG laser irradiation (Device); Sham Laser irradiation (Drug); Lidocaine (Drug); Vaseline (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Li Zhen Zhong
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insertion Depth at Initial Sensory Detection |
7.75; 4.65; 0.4; 8.55; 5.45; 0.41 | — |
| PRIMARY Insertion Depth at Pain |
12.30; 8.20; 1.17; 14.70; 9.15; 1.15 | — |
| PRIMARY Pain Score at Initial Sensory Detection |
0.65; 0.90; 1.27; 0.75; 1.07; 1.07 | — |
| PRIMARY Pain Score at Pain |
1.45; 1.79; 2.77; 1.37; 1.69; 1.81 | — |
| PRIMARY Heart Rate |
66.75; 75.35; 75.85; 65.95; 74.20; 76.15 | — |
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.
Eligibility Criteria
Inclusion Criteria
- could understand and follow given instructions
Exclusion Criteria
- excessive dental anxiety
- anesthesia allergies
- mucosal lesions
- cardiovascular disease
- diabetes
- pregnancy or lactation
- severe psychiatric disorders
- hearing abnormalities
- speech dysfunction
Data sourced from ClinicalTrials.gov (NCT07169032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.