Evaluation of Extraoral Low-level Laser Therapy (LLLT) with a 940nm Wavelength Diode Laser On Pain, Swelling, and Trismus after Impacted Mandibular Wisdom Teeth Surgery
Evaluation of Extraoral 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 study. The clinical trial is double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: lack of systemic disease, lack of chronic pain Lack of neurological disorders or psychiatry, no sensitivity to light Insensitivity to local anesthesia,not having acute pericoronitis, not having periodontal disease, no pregnancy, no breastfeeding, lack of smoking, don't use anti-inflammatory or analgesic drugs 2 weeks ago
Exclusion criteria:Lack of cooperation,view post-surgical side effects,see infection or acute abscess after surgery,lack of timely patient referral for postoperative laser sessions
Intervention groups
After surgery, patients receive laser epiploic 940nm diode laser (Ezlase 940 diode laser) at 0.5 watts per square inch immediately after laser suturing, and no laser will be applied on the other side (on the side of the placebo).
Main outcome variables
Trismus-pain-inflammation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N91
Registration date:2018-12-29, 1397/10/08
Registration timing:registered_while_recruiting
Last update:2018-12-29, 1397/10/08
Update count:0
Registration date
2018-12-29, 1397/10/08
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
2019-10-02, 1398/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Extraoral Low-level Laser Therapy (LLLT) with a 940nm Wavelength Diode Laser On Pain, Swelling, and Trismus after Impacted Mandibular Wisdom Teeth Surgery
Public title
Evaluation of Extraoral 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:
Lack of systemic disease
Lack of chronic pain
Lack of neurological disorders or psychiatry
No sensitivity to light
Insensitivity to local anesthesia
Not having acute pericoronitis
Not having periodontal disease
no pregnancy
no breastfeeding
Lack of smoking
Don't use anti-inflammatory or analgesic drugs 2 weeks ago
Exclusion criteria:
Unwillingness to continue cooperation
View post-surgical side effects
See infection or acute abscess after surgery
Lack of timely patient referral for postoperative laser sessions
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind.Participant and analyzer are blind (double blind).Participant and analyzer don't 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.1397.159
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
millimeter
2
Description
Inflammation
Timepoint
Before surgery, instantly and 2 and 7 days after surgery
Method of measurement
millimeter
3
Description
Pain
Timepoint
2 and 4 and 8 and 10 hours after surgery and 7 days 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: no laser will be applied on the other side (on the side of the placebo).