Determining the clinical success rate of CO2 lasers in both continuous and pulsed modes in patients requiring oral soft tissue surgeries
Design
Clinical trial with two groups under continuous laser and pulsed laser, with parallel groups, double-blind, randomized, phase 2 on 20 patients. Randomization is done manually.
Settings and conduct
20 patients candidated for oral soft tissue surgery were included in the study were easily and conveniently divided into two groups of 10 patients .The duration of surgery will be measured by a stopwatch. Bleeding during surgery will be recorded. Postoperative complications such as bleeding and hematoma will also be recorded in a checklist. The patient's pain will be measured using the VAS scale. Scar formation is also determined by visual examination and observation of hard, dark scar tissue after one month, and the patient's satisfaction or dissatisfaction is recorded .The present study is conducted in a double-blind manner, meaning that the pain assessor does not know which patients in each group are receiving continuous and pulsed CO2 laser. Also the patients will not be aware. It is not known which laser approach was used on them. A third person will keep the codes for each group and then give them to the data analyst.
Participants/Inclusion and exclusion criteria
Patients with oral soft tissue lesions are candidates for surgical excision of the lesion ; Age over 18 years
Intervention groups
In the continuous laser group, CW mode and 5 watts of power will be used (Ultera Dream Pulse V South Korea). In the pulsed laser group, CF mode with 248 watts of power, 50 Hz of frequency, 250 microseconds of pulse duration and 62 millijoules of pulse energy will be used.
Main outcome variables
The results of this study can be used to select the most appropriate CO2 laser method in patients undergoing oral soft tissue surgery and minimize its complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180224038840N5
Registration date:2026-01-03, 1404/10/13
Registration timing:prospective
Last update:2026-01-03, 1404/10/13
Update count:0
Registration date
2026-01-03, 1404/10/13
Registrant information
Name
Seyyed Amir Seyyedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3322 4288
Email address
seyedi.a@umsu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-01-10, 1404/10/20
Expected recruitment end date
2027-01-10, 1405/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pulsed and continuous mode of CO2 laser in oral soft tissue surgeries
Public title
Comparison of pulsed and continuous mode of CO2 laser in oral soft tissue surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with oral soft tissue lesions are candidates for surgical excision of the lesion
Age over 18 years old
Exclusion criteria:
Age under 18 years old
Pregnant women
Immunocompromised people
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Each participant is assigned a code, and a person outside the study, without prior knowledge, randomly assigns these codes to the continuous and pulsed CO2 laser treatment groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is conducted in a double-blind manner, meaning that the pain assessor does not know which patients in each group are receiving continuous and pulsed CO2 laser treatment, and on the other hand, the patients will not be aware of these conditions and will not know which laser approach was used on them. Only a third person will keep the codes of each group and then deliver them to the data analyst.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Resaalat ave
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2025-08-27, 1404/06/05
Ethics committee reference number
IR.UMSU.REC.1404.209
Health conditions studied
1
Description of health condition studied
oral soft tissue surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of surgery in seconds
Timepoint
The duration of the surgery will be measured by measuring the time between the start of the surgical procedure and its completion.
Method of measurement
Using a stopwatch
2
Description
Bleeding during surgery
Timepoint
During surgery
Method of measurement
By observation and by presence or absence
3
Description
Postoperative complications
Timepoint
The presence or absence of post-surgical complications such as bleeding and hematoma will be recorded in the checklist.
Method of measurement
By observation and by presence or absence
4
Description
Postoperative scar
Timepoint
After one month
Method of measurement
By observation and by presence or absence
5
Description
Postoperative pain
Timepoint
The patient's pain will be measured approximately 4 hours after surgery and 24 hours after surgery and at a fixed time every day for a week
Method of measurement
Using VAS scale
6
Description
Patient's satisfaction
Timepoint
The patient's satisfaction or dissatisfaction will be recorded after one month.
Method of measurement
Satisfaction or dissatisfaction will be recorded using a questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Under treatment with pulsed CO2 laser. In the pulsed laser group, CF mode with a power of 248, frequency of 50 Hz, pulse duration of 250 microseconds, and pulse energy of 62 millijoules will be used.
Category
Treatment - Devices
2
Description
Control group: will be treated with continuous wave CO2 laser with a wavelength of 10600 nm. In the continuous wave laser group, CW mode and 5 watts power will be used with CO2 laser (Ultera Dream Pulse V South Korea).