Evaluating the Effect of Low-Level Laser Therapy on pain and jaw Trismus Following Surgical Extraction of mandibular embedded wisdom teeth
Design
26 patients undergoing surgery for extraction of mandibular wisdom teeth are studied. both of the third molar impacted tooth are extracted . The patient gargles for 30 seconds.All operations are performed by a surgeon using a standard and similar method. In a randomized post-jaundice operation, a jaw (left or right) portion of LLLT with a wavelength of 808 nm from the buccal and lingual 660 The nanometer is placed on the crystal line and on the other side of the placebo.
Settings and conduct
both of the third molar impacted tooth are extracted .All operations are performed by a surgeon using a standard and similar method. In a randomized post-jaundice operation, a jaw (left or right) portion LLLT with a wavelength of 808 nm from the buccal and lingual 660 The nanometer is placed on the crystal line and on the other side of the placebo .Surgery is the personal office of Dr. Saman Nasiri.
Participants/Inclusion and exclusion criteria
Patients with bilateral jaundiced mesioangular mandibular teeth have a requirement for study.
Patients presenting their medical history or in the physical examination of adrenal suppression or who have used corticosteroid for more than 3 months - - Patients with TMJ inflammation and decreased Excessive open mouths are excluded from the study
Intervention groups
intervention group:26 specimens that are accidentally inflamed with low-level laser after one-side wisdom teeth surgery. control group: 26 mandibular wisdom tooth is facing the same sample of the intervention group but the placebo is excreted.
Main outcome variables
Variables are the severity of pain and maximal opening mouth.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181116041672N1
Registration date:2019-01-02, 1397/10/12
Registration timing:retrospective
Last update:2019-01-02, 1397/10/12
Update count:0
Registration date
2019-01-02, 1397/10/12
Registrant information
Name
Aisa Mahmoody
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3321 7199
Email address
docmahmoody@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2018-09-06, 1397/06/15
Trial completion date
2018-09-22, 1397/06/31
Scientific title
Evaluating the Effect of Low-Level Laser Therapy on pain and jaw Trismus Following Surgical Extraction of mandibular embedded wisdom teeth
Public title
Evaluating the Effect of Low-Level Laser Therapy on pain and jaw Trismus Following Surgical Extraction of mandibular embedded wisdom teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with bilateral impacted mesioangular mandibular teeth have a candidate for entering in this study
Exclusion criteria:
Patients presenting their medical history or in the physical examination of adrenal suppression
Patients who have been taking corticosteroids for more than 3 months
Patients with impacted mandibular one-side wisdom teeth
Patients with TMJ inflammation and reduced oral open mouth limits are excluded
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
26
More than 1 sample in each individual
Number of samples in each individual:
2
Two surgeries are performed on both sides of the mandible to remove the teeth of the wisdom
Actual sample size reached:
26
More than 1 sample in each individual
Actual sample size in each individual:
2
Two surgeries are performed on both sides of the mandible to remove the teeth of the wisdom
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the person analysing the data are unaware of which side emited LLLT and which side emited the placebo (ie, laser probe without laser output)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan university of medical science
Street address
Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.LUMS.REC.1397.107
Health conditions studied
1
Description of health condition studied
Extraction of embedded mandibular wisdom teeth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain and trismus
Timepoint
Before and after surgery
Method of measurement
Determination of Maximal Mouth opening by Measuring the Distance Between insisors Before and After Surgery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We have 26 specimens with mesio-angulated bilateral dental wisdom. One side of the wisdom is selected randomly and performed by the surgeon in a standard manner. After a standard operation low-power laser with wavelength of 808 and 660 nm, the conftec brand use with the power of 2 jules per square centimeter for 16 seconds in two points on the Suture line, and on each buccal and lingual topline, two points are displayed, and at the origin of the master at 2 points with a wavelength of 808 nm and the same The value is 16 seconds in two points
Category
Treatment - Surgery
2
Description
Control group: 26 mandibular wisdom tooth is facing the same sample of the intervention group but the placebo is excreted
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Patients referring to Dr. Saman Nasiri's personal office
Full name of responsible person
Dr. Saman Nasiri
Street address
Chaharrah Bank
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 66 3333 8355
Email
Dr_nasiri7@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr.Sara sepahvandy
Street address
Shohada
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 66 3333 8355
Email
Dr_nasiri7@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Aisa Mahmoody
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Razi
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 66 3321 7199
Email
docmahmoody@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr Saman Nasiri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Razi
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 66 3333 8355
Email
dr_nasiri7@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Aisa Mahmoody
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Razi
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Phone
+98 66 3321 7199
Email
docmahmoody@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Dissatisfaction patients
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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
How to do research, type of sampling, surgical method and statistical method
When the data will become available and for how long
It is possible at any time
To whom data/document is available
All researchers have access to data
Under which criteria data/document could be used
All researchers have access to data
From where data/document is obtainable
All researchers have access to data
What processes are involved for a request to access data/document