Trial Outcomes & Findings for The Effect of Er,Cr:YSGG Laser-assisted Topical Anesthetic on Oral Mucosal Anesthesia (NCT NCT07169032)
NCT ID: NCT07169032
Last Updated: 2025-12-04
Results Overview
Insert a sterile needle into the mucosa at the sites. Record the Insertion depth when participants perceived an "initial sensory detection"
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
20 participants
Primary outcome timeframe
10, 20, 30, 40, and 50 minutes
Results posted on
2025-12-04
Participant Flow
Unit of analysis: site
Participant milestones
| Measure |
Laser + Lidocaine
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.
|
Sham Laser + Lidocaine
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.
|
Sham Laser + Vaseline
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20 20
|
20 20
|
20 20
|
|
Overall Study
COMPLETED
|
20 20
|
20 20
|
20 20
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Er,Cr:YSGG Laser-assisted Topical Anesthetic on Oral Mucosal Anesthesia
Baseline characteristics by cohort
| Measure |
Laser + Lidocaine
n=20 site
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.
|
Sham Laser + Lidocaine
n=20 site
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.
|
Sham Laser + Vaseline
n=20 site
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.
|
Total
n=60 site
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=60 site
|
|
Age, Categorical
Between 18 and 65 years
|
20 site
n=20 site
|
20 site
n=20 site
|
20 site
n=20 site
|
60 site
n=60 site
|
|
Age, Categorical
>=65 years
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=60 site
|
|
Sex: Female, Male
Female
|
10 site
n=20 site
|
10 site
n=20 site
|
10 site
n=20 site
|
30 site
n=60 site
|
|
Sex: Female, Male
Male
|
10 site
n=20 site
|
10 site
n=20 site
|
10 site
n=20 site
|
30 site
n=60 site
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=60 site
|
|
Race (NIH/OMB)
Asian
|
20 site
n=20 site
|
20 site
n=20 site
|
20 site
n=20 site
|
60 site
n=60 site
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=60 site
|
|
Race (NIH/OMB)
Black or African American
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=60 site
|
|
Race (NIH/OMB)
White
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=60 site
|
|
Race (NIH/OMB)
More than one race
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=60 site
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=20 site
|
0 site
n=60 site
|
|
Region of Enrollment
China
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 10, 20, 30, 40, and 50 minutesInsert a sterile needle into the mucosa at the sites. Record the Insertion depth when participants perceived an "initial sensory detection"
Outcome measures
| Measure |
Sham Laser + Vaseline
n=20 Participants
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.
|
Sham Laser + Lidocaine
n=20 Participants
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.
|
Laser + Lidocaine
n=20 Participants
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.
|
|---|---|---|---|
|
Insertion Depth at Initial Sensory Detection
10 min
|
0.4 mm
Standard Deviation 1.34
|
4.65 mm
Standard Deviation 3.10
|
7.75 mm
Standard Deviation 4.35
|
|
Insertion Depth at Initial Sensory Detection
20 min
|
0.41 mm
Standard Deviation 1.35
|
5.45 mm
Standard Deviation 3.72
|
8.55 mm
Standard Deviation 5.40
|
|
Insertion Depth at Initial Sensory Detection
30 min
|
0.38 mm
Standard Deviation 1.34
|
3.99 mm
Standard Deviation 4.40
|
9.28 mm
Standard Deviation 7.07
|
|
Insertion Depth at Initial Sensory Detection
40 min
|
0.375 mm
Standard Deviation 1.34
|
1.79 mm
Standard Deviation 2.74
|
4.40 mm
Standard Deviation 4.89
|
|
Insertion Depth at Initial Sensory Detection
50 min
|
0.52 mm
Standard Deviation 2.01
|
1.44 mm
Standard Deviation 3.50
|
2.56 mm
Standard Deviation 3.60
|
PRIMARY outcome
Timeframe: 10, 20, 30, 40, and 50 minutesInsert a sterile needle into the mucosa at the sites. Record the Insertion depth when participants felt "pain".
Outcome measures
| Measure |
Sham Laser + Vaseline
n=20 Participants
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.
|
Sham Laser + Lidocaine
n=20 Participants
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.
|
Laser + Lidocaine
n=20 Participants
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.
|
|---|---|---|---|
|
Insertion Depth at Pain
10 min
|
1.17 mm
Standard Deviation 2.60
|
8.20 mm
Standard Deviation 3.58
|
12.30 mm
Standard Deviation 5.42
|
|
Insertion Depth at Pain
20 min
|
1.15 mm
Standard Deviation 2.72
|
9.15 mm
Standard Deviation 3.90
|
14.70 mm
Standard Deviation 6.51
|
|
Insertion Depth at Pain
30 min
|
0.76 mm
Standard Deviation 1.78
|
7.46 mm
Standard Deviation 5.22
|
15.45 mm
Standard Deviation 6.79
|
|
Insertion Depth at Pain
40 min
|
1.13 mm
Standard Deviation 2.40
|
4.84 mm
Standard Deviation 4.19
|
10.25 mm
Standard Deviation 5.93
|
|
Insertion Depth at Pain
50 min
|
0.95 mm
Standard Deviation 2.47
|
2.72 mm
Standard Deviation 4.76
|
5.46 mm
Standard Deviation 4.87
|
PRIMARY outcome
Timeframe: 10, 20, 30, 40, and 50 minutesInsert 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.
Outcome measures
| Measure |
Sham Laser + Vaseline
n=20 Participants
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.
|
Sham Laser + Lidocaine
n=20 Participants
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.
|
Laser + Lidocaine
n=20 Participants
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.
|
|---|---|---|---|
|
Pain Score at Initial Sensory Detection
10 min
|
1.27 Units on a Scale
Standard Deviation 0.77
|
0.90 Units on a Scale
Standard Deviation 0.39
|
0.65 Units on a Scale
Standard Deviation 0.34
|
|
Pain Score at Initial Sensory Detection
20 min
|
1.07 Units on a Scale
Standard Deviation 0.74
|
1.07 Units on a Scale
Standard Deviation 0.60
|
0.75 Units on a Scale
Standard Deviation 0.62
|
|
Pain Score at Initial Sensory Detection
30 min
|
1.18 Units on a Scale
Standard Deviation 0.83
|
0.95 Units on a Scale
Standard Deviation 0.56
|
0.64 Units on a Scale
Standard Deviation 0.35
|
|
Pain Score at Initial Sensory Detection
40 min
|
1.03 Units on a Scale
Standard Deviation 0.80
|
0.92 Units on a Scale
Standard Deviation 0.55
|
0.61 Units on a Scale
Standard Deviation 0.35
|
|
Pain Score at Initial Sensory Detection
50 min
|
1.07 Units on a Scale
Standard Deviation 0.74
|
0.93 Units on a Scale
Standard Deviation 0.59
|
0.75 Units on a Scale
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: 10, 20, 30, 40, and 50 minutesInsert 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.
Outcome measures
| Measure |
Sham Laser + Vaseline
n=20 Participants
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.
|
Sham Laser + Lidocaine
n=20 Participants
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.
|
Laser + Lidocaine
n=20 Participants
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.
|
|---|---|---|---|
|
Pain Score at Pain
10 min
|
2.77 Units on a Scale
Standard Deviation 2.99
|
1.79 Units on a Scale
Standard Deviation 0.84
|
1.45 Units on a Scale
Standard Deviation 0.75
|
|
Pain Score at Pain
20 min
|
1.81 Units on a Scale
Standard Deviation 0.82
|
1.69 Units on a Scale
Standard Deviation 0.76
|
1.37 Units on a Scale
Standard Deviation 0.71
|
|
Pain Score at Pain
30 min
|
1.87 Units on a Scale
Standard Deviation 0.97
|
1.64 Units on a Scale
Standard Deviation 0.84
|
1.22 Units on a Scale
Standard Deviation 0.66
|
|
Pain Score at Pain
40 min
|
1.80 Units on a Scale
Standard Deviation 0.91
|
1.67 Units on a Scale
Standard Deviation 0.78
|
1.21 Units on a Scale
Standard Deviation 0.64
|
|
Pain Score at Pain
50 min
|
1.79 Units on a Scale
Standard Deviation 0.81
|
1.58 Units on a Scale
Standard Deviation 0.73
|
1.35 Units on a Scale
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: 10, 20, 30, 40, and 50 minutesInsert a sterile needle into the mucosa at the sites. Record the heart rate with an electrocardiogram monitor when participants felt "pain".
Outcome measures
| Measure |
Sham Laser + Vaseline
n=20 Participants
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.
|
Sham Laser + Lidocaine
n=20 Participants
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.
|
Laser + Lidocaine
n=20 Participants
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.
|
|---|---|---|---|
|
Heart Rate
10 min
|
75.85 BPM
Standard Deviation 9.02
|
75.35 BPM
Standard Deviation 7.22
|
66.75 BPM
Standard Deviation 7.48
|
|
Heart Rate
20 min
|
76.15 BPM
Standard Deviation 10.30
|
74.20 BPM
Standard Deviation 9.16
|
65.95 BPM
Standard Deviation 7.92
|
|
Heart Rate
30 min
|
75.60 BPM
Standard Deviation 8.89
|
74.45 BPM
Standard Deviation 9.17
|
65.05 BPM
Standard Deviation 7.54
|
|
Heart Rate
40 min
|
76.95 BPM
Standard Deviation 8.40
|
74.20 BPM
Standard Deviation 9.89
|
66.40 BPM
Standard Deviation 7.74
|
|
Heart Rate
50 min
|
76.80 BPM
Standard Deviation 9.33
|
74.10 BPM
Standard Deviation 8.90
|
65.70 BPM
Standard Deviation 7.40
|
Adverse Events
Laser + Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Laser + Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Laser + Vaseline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
LI ZHEN ZHONG
First Affiliated Hospital of Jinan University
Phone: +8613711706774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place