The evaluation of Doctor Smile WISER/LA3D0 001.3 Diode laser on swelling and trismus after impacted third molar surgery
Design
A clinical trial with two groups of intervention (laser irradiation) and control (no irradiation), Randomized double-blinded, . The 40 enrolled individuals were randomized and sex matched into two groups of laser and control.
Settings and conduct
All surgeries and laser irradiations were done by one surgeon in both groups measurements will do by dental student unaware from process
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-25 years of age and complete systemic health with mesio-angular Class II, I and A third molar tooth impaction
Exclusion criteria: Systemic disease, local infection such as pericornitis, history of using drugs such as NSAIDs up to 12 hours before surgery, use of contraceptives, pregnancy or lactation
Intervention groups
The emmision of low level laser after surgical removal of third molars intraorally and extraorally and use of ordinary light of laser divice on control group.
Main outcome variables
Swelling: the horizontal distance between lip commissure and auricle and the vertical distance between lateral cantus and mandibular angle ; Trismus distance between incisal edges of upper and lower centrals
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180920041076N1
Registration date:2019-10-05, 1398/07/13
Registration timing:retrospective
Last update:2019-10-05, 1398/07/13
Update count:0
Registration date
2019-10-05, 1398/07/13
Registrant information
Name
Hadi hashem zehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3824 1949
Email address
h.hashemzehi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
2015-07-11, 1394/04/20
Actual recruitment end date
2015-12-19, 1394/09/28
Trial completion date
2016-02-03, 1394/11/14
Scientific title
Evaluation of low intensity laser therapy on trismus and swelling after impacted mandibular third molar surgery
Public title
Effect of laser in dental surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-25 years of age
Mesio-angular Class I or II, A impacted third molar
Exclusion criteria:
systemic disease
local infection
smoking
pregnancy
lactation
use of drugs such as contraceptives or NSAIDS
Age
From 18 years old to 25 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization was used for gender matching. Then they were simply randomized into the two intervention and control groups.
The unit of randomization was individual and sealed envelopes were used as a randomization tool.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients inform that in this study they are irradiated by laser randomly and a laser that was not on was used in the control group without their awareness, therefore in both groups we stimulated the use of lase the The colleuge who measures the data was also unaware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Dr Hesabi Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2015-06-28, 1394/04/07
Ethics committee reference number
7392
Health conditions studied
1
Description of health condition studied
Trismus and swelling after surgical removal of third molar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Inter-incisal distance of the jaws
Timepoint
Before surgery,2 and 7 days after surgery
Method of measurement
By a ruler
2
Description
The horizontal distance between lip commissure and auricle
Timepoint
Before surgery,2 and 7 days after surgery
Method of measurement
By a ruler and silk suture
3
Description
The vertical distance between lateral cantus and mandibular angle
Timepoint
Before surgery,2 and 7 days after surgery
Method of measurement
By a ruler and silk suture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A Doctor Smile WISER/ (LAMBDA Scientifica S.r.l,Italy) 980 nm laser with a setting of CW, at 200mw for 60s of irradiation was given from a 1 cm distance with a Flattop therapy hand piece (12j/cm2), intraorally on the buccal and lingual sides of the treated site and also extraoraly on the masseter muscle insertion site with a with a continuous wave mode( a total of 36J/cm2).
Category
Treatment - Devices
2
Description
Control group: A laser that was not on was placed in the same areas (Intra-orally on the Buccal and Lingual of the surgical area and extra-orally on the Master muscle) to create similar conditions for the patients.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences, Zahedan School of Dentistry
Full name of responsible person
Kimya Arab
Street address
Mehr Ave
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Email
dentistry@zaums.ac.ir
Web page address
http://www.dent.zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Hooshang Rafighdoost
Street address
Dr Hesabi Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hadi Hashem Zehi
Position
Assistante professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Mehr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
hashemzehi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hadi Hashem Zehi
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Mehr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
hashemzehi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hadi Hashem Zehi
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Mehr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
hashemzehi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
January 2017-January 2022
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
all types of analysis are allowed
From where data/document is obtainable
by Email: hashemzehi@gmail.com
What processes are involved for a request to access data/document