Protocol summary

Study aim
Efficacy of Intraoral Low-level Laser Therapy (LLLT) with a 940nm Wavelength Diode Laser On Pain, Swelling, and Trismus after Impacted Mandibular Wisdom Teeth Surgery
Design
This clinical trial is performed on 25 patients aged 18-40 years old (aged 40- 18 years) with a third molar impacted on both sides of the mandible due to a single-person clinical study. The clinical trial is double-blinded
Settings and conduct
This clinical trial is performed on 25 patients aged 18-40 years old (aged 40- 18 years) with a third molar impacted on both sides of the mandible due to a single-person clinical and randomize study. The clinical trial is double-blinded.We will use a 940 nm diode laser inside the mouth immediately after suturing on the tested side.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mandibular Wisdom Teeth Surgery candidate, 18 to 40 years Exclusion criteria:Dissatisfaction, lack of systemic disease ,not having periodontal disease
Intervention groups
We will use a 940 nm diode laser inside the mouth immediately after suturing on the tested side. In side of placebo after the surgery, the tip of the fiber is placed, but no radiation occurs in placebo group.
Main outcome variables
Trismus-pain-inflammation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N110
Registration date: 2019-05-04, 1398/02/14
Registration timing: retrospective

Last update: 2019-05-04, 1398/02/14
Update count: 0
Registration date
2019-05-04, 1398/02/14
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Intraoral Low-level Laser Therapy (LLLT) with a 940nm Wavelength Diode Laser On Pain, Swelling, and Trismus after impacted mandibular wisdom teeth surgery
Public title
Efficacy of Intraoral Low-level Laser Therapy (LLLT) with a 940nm Wavelength Diode Laser On Pain, Swelling, and Trismus after impacted mandibular wisdom teeth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mandibular Wisdom Teeth Surgery candidate 18 to 40 years
Exclusion criteria:
Dissatisfaction systemic disease having periodontal disease
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind.Participant and analyzer are blind (double blind).Participant and analyzer not aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.ARAKMU.REC.1397.158

Health conditions studied

1

Description of health condition studied
Mandibular Wisdom Teeth Surgery
ICD-10 code
K02.7
ICD-10 code description
Dental root caries

Primary outcomes

1

Description
Trismus
Timepoint
Before surgery, instantly and 2 and 7 days after surgery
Method of measurement
ruler

2

Description
Inflammation
Timepoint
Before surgery, instantly and 2 and 7 days after surgery
Method of measurement
ruler

3

Description
Pain
Timepoint
Day 1 to 7 after surgery
Method of measurement
Visual analog scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After surgery, patients receive laser epiploic 940nm diode laser (Ezlase 940 diode laser) at 0.5 watts per square inch immediately after laser suturing
Category
Treatment - Surgery

2

Description
Control group: On the side of the placenta after the surgery, the tip of the fiber is placed, but no radiation occurs.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental clinic
Full name of responsible person
Dr Ehsan Momeni
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3417 3645
Email
e.momeni@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Science
Full name of responsible person
Dr Mohammad Arjmanzadegan
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3417 3645
Email
m.arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Science
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
Arak University of Medical Sciences
Full name of responsible person
Seyed Behrouz Jalali
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3417 3505
Email
behrouzjalali@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ehsan Momeni
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3417 3505
Email
E.momeni@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Melika Rajaee Arbabi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3417 3505
Email
melishada20@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
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Momeni Payambar Azam Complex, Basij square, Sardasht, Arak E.momeni@arakmu.ac.ir
What processes are involved for a request to access data/document
They have to write letters to the professors and the university. Duration 1 month
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