The purpose of this study is to evaluate the effect of low level laser therapy on post operative pain after clinical crown lengthening procedures.
Design
two arm parallel group randomized clinical trial, one way blinded. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site.
Settings and conduct
the patients will be selected from visitors of dentistry faculty of tabriz university of medical sciences and private practice office. after conducting the surgery the patient will be treated with either low lever laser or plasbo laser according to which group they are in. appointments will be given for 3 and 7 days after surgery for further steps. for pain evaluation a quastionnaire will be used and patients will be asked of their pain up to 10 days after surgery. also the amount of pain relieving medication they are taking will be asked.
Participants/Inclusion and exclusion criteria
inclusion criteria are: having age of between 18 and 60 years, not having systemic conditions and good oral hygiene. exclusion criteria are being a smoker, having systemic conditions and drug induced gum hyperplasia.
Intervention groups
in the intervention group, low level laser with GaAlAs diode laser with 100 milliwatts power and energy density of 4 jules per square centimeters and wave length of 660 nano meters is used at the day of surgery, 3 days after surgery and 7 days after surgery each time for duration of 30 seconds on the site of surgery. in the control group the laser is used in the same manner but it is deactivated and is held on the surgery site for 30 seconds.
Main outcome variables
amount of post operative pain; amount of prescribed pain relieving medication taken for post operative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180114038364N1
Registration date:2020-05-02, 1399/02/13
Registration timing:prospective
Last update:2020-05-02, 1399/02/13
Update count:0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
Mehrnoosh Sadighi Shamami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
mehrnoosh1378@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Low Level Laser Therapy on post operative pain after clinical crown lengthening procedures
Public title
effect of low level laser therapy on postoperative pain in gum surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the patients must be between 18 and 60 years of age
patients must not have systemic conditions
patients must have adequate oral hygiene
Exclusion criteria:
if the patient is a smoker.
if the patient has systemic conditions.
if the patient has drug induced gum hyperplasia.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
randomization will be individually and simple. using the table of randomized numbers, each individual will be put in either of the laser therapy or control groups. Odd numbers will be assigned to the intervention group and even numbers will be assigned to the control group. the analyst will move in a specific direction in the table in one row or column and assign the numbers to the patients. the surgeon and the researcher will not know the patient's group until the surgery is over. after the surgery, the researcher will know the individual's code number and if the code is an odd number then patient will be referred for low level laser therapy and if the code number is an even number, the patient will be referred for placebo laser therapy.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is designed as one way blind and the patients will be blinded. all the participants in the study will be informed that they will receive low level laser therapy after the surgery so that the effect of laser on post operation pain is evaluated. same information and instructions will be given to all the patients regarding the laser therapy. in the laser therapy group, the laser is applied with a specific dose and specific duration and within a specific distance from the site of surgery. in the control group the same laser will be held for the same duration and same distance from the surgery site but the laser is not active and the patient will not be informed that the laser is not active.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tabriz university of medical sciences
Street address
No. 96, 3rd hafez avenue, eil goli boulevard, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166884461
Approval date
2020-03-09, 1398/12/19
Ethics committee reference number
IR.TBZMED.REC.1398.1299
Health conditions studied
1
Description of health condition studied
post operative pain
ICD-10 code
G89.18
ICD-10 code description
other acute post procedural pain
Primary outcomes
1
Description
The amount of post operative pain on a scale of 0 to 10
Timepoint
Daily up to 10 days after the day of surgery
Method of measurement
Using Visual analogue scale (VAS)
2
Description
amount of usage of prescribed pain relieving medication
Timepoint
Daily up to 10 days after surgery
Method of measurement
Asking the patient whether they took the prescribed pain relieving medication and if yes how many.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: a diode GaAlAs laser with a power of 100 milliwatts, wave length of 660 nano meters and energy density of 4 jules per square centimetres will be used on the surgery site for a duration of 30 seconds. this will be done at the day of surgery, 3 days after surgery and 7 days after surgery.
Category
Treatment - Devices
2
Description
Control group: a diode GaAlAs laser(same with the intervention group) will be used deactivated on the site of surgery for 30 seconds. this will be done at the day of surgery, 3 days after surgery and 7 days after surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry faculty of tabriz university of medical sciences
Full name of responsible person
Sina Ranjbaraghdam
Street address
End of golgasht st. , daneshgah st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
dent.fac@tbzmed.ac.ir
Web page address
https://dentistryfac.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
mohammad samiei
Street address
Third floor, Central building no.2, Tabriz university of medical sciences, golgasht st, Tabriz