The aim of this study is evaluation of effectiveness of Low Level Laser Therapy in reducing complications after the Mandibular Wisdom Tooth.
Design
Double blinded clinical trial randomised into 2 parallel groups with 72 samples from 36 patients
Settings and conduct
Patients of Dental Faculty of Guilan will be chosen if they are satisfied with inclusion criteria. The first therapist will perform surgerys and the second therapist is responsible for Laser Therapy to inform the analyst about receiving laser or not without knowledge of patients, the first and third therapist. The third therapist will measure the variables.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with ASA 1
Patients with same level of Mandibular Third Molar in term of Pell & Gregory and Winter category
Patients with good oral health without oral infection
No alcoholic and smoker patients
Patients under 40 years old
Patients referred only for Wisdom Tooth Surgery
Non inclusion criteria:
Patients with ASA 2 and more
Patients with acute Pericoronitis in past month
Patients with chronic pain and Mental and Neurological illnesses
Patients under Corticosteroid Therapy
Patients with severe Periodental disease
Patients with Pathology relative to adjacent tooth
Patients with Allergy to local anesthesias or prescribed medicines in study
Patients under treatment with Analgesic and Anti-inflammatory drugs
In the cases of Laser Therapy contraception in patients
Pregnant and breast feeding patients
Patients who used Antibiotics or Analgesic other than determined protocol before surgery
Intervention groups
Samples are divided into two groups: Laser group and placebo group
Main outcome variables
Pain, Trismus , swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180826040872N1
Registration date:2019-03-03, 1397/12/12
Registration timing:prospective
Last update:2019-03-03, 1397/12/12
Update count:0
Registration date
2019-03-03, 1397/12/12
Registrant information
Name
ali Khalighsigaroodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3333 0862
Email address
ali.khalighsigaroodi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Low Level Laser Therapy (LLLT) in reducing symptoms after the surgery of the Mandibular Wisdom Tooth
Public title
Evaluation of effect of Laser in reducing symptoms of the Mandibular Wisdom tooth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA 1
Patients with same level of Mandibular Third Molar in term of Pell & Gregory and Winter category
Patients with good oral health without oral infection
No alcoholic and smoker patients
Patients under 40 years old
Patients referred only for Wisdom Tooth Surgery
Exclusion criteria:
Patients with ASA 2 and more
Patients with acute Pericoronitis in past month
Patients with chronic pain and Mental and Neurological illnesses
Patients under Corticosteroid Therapy
Patients with severe Periodental disease
Patients with Pathology relative to adjacent tooth
Patients with Allergy to local anesthesias or prescribed medicines in study
Patients under treatment with Analgesic and Anti-inflammatory drugs
In the cases of Laser Therapy contraception in patients
Pregnant and breast feeding patients
Patients who used Antibiotics or Analgesic other than determined protocol before surgery
Age
To 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
36
More than 1 sample in each individual
Number of samples in each individual:
2
In this study patients with bilateral Wisdom teeth will be chosen so that the Wisdom Tooth of one side will be placed in placebo group randomly and the other side will be as Laser group and this way individual characteristics will be eliminated. As a result 2 samples from each patient is taken and number of samples are 72 in the study.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed by using R software by statistician and based on that Wisdom Tooth of one side ( as surgical field ) randomly will be placed in placebo group and the other side will be placed in Laser group
Blinding (investigator's opinion)
Double blinded
Blinding description
The first therapist ( surgeon ) will perform all surgerys and the second therapist after surgery will do Laser Therapy for Laser group and for placebo group he will put the handpiece on the field as it is off. The second therapist will inform the analyst about both groups receiving Laser or not ( without knowledge of patients, first and third therapists ). The third therapist will measure the variables.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of guilan university of medical sciences
Street address
Fuman_Saravan ring road, GUMS complex, dentistry faculty
City
rasht
Province
Guilan
Postal code
4188794755
Approval date
2019-01-12, 1397/10/22
Ethics committee reference number
IR.GUMS.REC.1397.402
Health conditions studied
1
Description of health condition studied
trismus after the Mandibular Wisdom Tooth surgery
ICD-10 code
R25.2
ICD-10 code description
Cramp and spasm
2
Description of health condition studied
extraction of mandibular wisdom tooth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Score of pain in Baker Wong faces scale
Timepoint
Measurement of pain every 2 hours up to 6 hours after surgery and then once in the morning and once in the night before sleeping up to three days ( at a specified hour )
Method of measurement
Baker Wong faces scale
2
Description
Trismus and opening rate of patient's mouth
Timepoint
Evaluation of trismus before surgery, first and seventh day after surgery
Method of measurement
The interval between right Maxillary and Mandibular Central Teeth will be measured by ruler ( centimeter ).
3
Description
Edema
Timepoint
Edema will be measured before surgery, first and seventh day after surgery.
Method of measurement
5 points are used: the Tragus, the Labial Commissure, the Lateral Canthus of eye, the Gonion and the pogonion. By using a piece yarn the intervals of Tragus to Labial Commissure, Lateral Canthus of eye to Gonion and Tragus to pogonion are measured and will be specified by rules ( centimeter ).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group ( Laser group ): receiving Low Level Laser with 810 nm wavelength after the Mandibular Wisdom Tooth surgery
Category
Treatment - Devices
2
Description
Control group ( placebo group ): receiving placebo treatment ( The handpiece is placed on the field of surgery but the appliance is off. )
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty of Guilan University of Medical science
Full name of responsible person
Arash Ghafoori
Street address
Rasht, Fuman-Saravan ring road, GUMS complex
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6406
Email
dental@gums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Hamid Neshan Dar Asli
Street address
Fuman-Saravan ring road, GUMS Comples
City
rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6406
Email
dental@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Donya maleki
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
dentistry
Street address
Fuman-Saravan ring road, GUMS complex
City
rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6406
Email
donyamaleki93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Ali Khaligh Sigaroodi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fuman-Saravan ring road, GUMS complex
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6406
Email
dental@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Donya Maleki
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Fuman-Saravan ring road, GUMS complex
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6406
Email
donyamaleki93@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
All data relative to measured index (pain, edema and trismus ) are shared after unidentifying patients.
When the data will become available and for how long
6 months or 1 year after the publication of final results
To whom data/document is available
Anyone can access the data
Under which criteria data/document could be used
In order to design and perform similar research or as a base for more development studys
From where data/document is obtainable
Donya Maleki: donyamaleki93@gmail.com
Dr Sigaroodi: Ali.khaligsigaroodi@gmail.ac.ir
What processes are involved for a request to access data/document
After sending an email and explaining about the study, they will receive the data in a month.