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
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.