Comparison of efect of laser vs surgery pain of patients
Design
All patients that come to oral medicine department of shahed dental school in 44 patients 22 patients do surgery by laser and other group do by surgey by blade and the sheed put in pocket and the randome pick by thesis advisor that dont any rule in the process and do by excell software
Settings and conduct
All patients that come to oral medicine department of shahed dental school,that have exophytic oral soft tissue that should be removal and we will fo by laser diod and surgery by blade
Participants/Inclusion and exclusion criteria
If patient not accept side effects,or patient accepts side effects
Intervention groups
All patients with minimum 18 years old that have exophytic oral soft tissue that need to be removal in 2 group first will remove by laser diode and second do by surgey by blade for comparison of pain of patient asd healing on surgical site
Main outcome variables
Comparison of pain,healing and patient comfortable
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260718070248N1
Registration date:2026-09-01, 1405/06/10
Registration timing:prospective
Last update:2026-09-01, 1405/06/10
Update count:0
Registration date
2026-09-01, 1405/06/10
Registrant information
Name
Seyed saman Khademi
Name of organization / entity
Shahed dental school
Country
Iran (Islamic Republic of)
Phone
+98 21 7768 5291
Email address
samankhademi1999@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-11-20, 1405/08/29
Expected recruitment end date
2027-01-18, 1405/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the clinical effect of 915nm diode laser vs conventional surgery in excision of Benign exophytic of oral soft tissue lesions
Public title
Comparsion of laser vs surgery in removal of oral exophytic bening soft tissue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years old
Patient dont have uncontrolled systemic disease
Patient have exophytic orql soft tissue that should be surgery
Exclusion criteria:
Failure to attend follow-up appointments
Fear of laser surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be conducted as a randomized controlled trial (RCT) with a parallel-group design. The study population will be randomly divided into two groups: the first group will be treated with a 915 nm diode laser, and the second group will undergo traditional surgery. Participant allocation will be performed using a blocked randomization method (block size of 4) via Excel software, carried out by a statistical consultant who is not involved in the operational procedures.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessors are blinded to the treatment allocation. Patients and the investigator administering the intervention are not blinded due to the obvious differences between laser and conventional surgical procedures. Randomization is performed using sealed opaque envelopes prepared by an independent statistician who is not involved in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine – Shahed University (Research Ethics Committee)
Street address
Tehran, at the beginning of the Tehran-Qom Highway, opposite the Holy Shrine of Imam Khomeini.
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2026-06-14, 1405/03/24
Ethics committee reference number
IR.SHAHED.MED.REC.1405.032
Health conditions studied
1
Description of health condition studied
Exophytic benign oral soft tissue
ICD-10 code
Y69
ICD-10 code description
Unspecified misadventure during surgical and medical care
Primary outcomes
1
Description
Pain
Timepoint
Day of surgery recall after 1week and 2week
Method of measurement
VAS chart
Secondary outcomes
empty
Intervention groups
1
Description
First group under surgery by laser diod laser 915 in laser room of shahed dental school
Category
Treatment - Surgery
2
Description
Secound group do surgery by traditional surgery by blade no15 and suture in surgery room