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Evaluation of the of low-level laser photo biomodulation effect on enhancement of post Lefort I and sagittal split osteotomy surgery neurosensory deficits with clinical neurosensory testing (CNST)

Protocol summary

Study aim
Evaluation and comparison the mean values of quantitative neurosensory measurement after orthognatic surgury with low level laser in patients who want Lefort I and sagittal split osteotomy surgery in 12 patients(6female and 6 male)
Design
Clinical trials with a control group, with parallel groups, double-blind, randomized.6 patients in control group and 6 patients in Intervention group.
Settings and conduct
Patients candidates for orthognathic surgery in Alzahra and Kashani hospitals are informed about the study and after approval of inclusion criterias ,are entered to the study. After surgery(Lefort I and sagittal split osteotomy surgery), they are exposed to low level laser unilaterally and having the other side as control group with placebo effect of laser on stand-by mode with patient blinded to the side in 2 determined recalls after surgery, neurosensory changes are evaluated by clinical neurosensory tests(Thermal test,two point descrimination,light touch,pin prick)
Participants/Inclusion and exclusion criteria
Inclusion criteria:: healthy systemic status: age 18-30, healthy neurological system, informed consent, Patients candidate for orthognathic surgery. Exclusion criteria: Any local or systemic disease, age under 18 and over 30 years, history of trauma and jaw fracture, history of previous maxillofacial surgery,lack of cooperation,Pregnancy, Immune system defects, smoking, Taking muscle relaxant and sedative and anti-inflammatory drugs over the past 3 months.
Intervention groups
Control group: Orthognathic surgery without laser exposure. Intervention group: Orthognathic surgery then exposure using GaAlAs low level laser.
Main outcome variables
Quantitative neurosensory changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200411047026N1
Registration date: 2020-05-11, 1399/02/22
Registration timing: registered_while_recruiting

Last update: 2020-05-11, 1399/02/22
Update count: 0
Registration date
2020-05-11, 1399/02/22
Registrant information
Name
Maryam Haghighat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 0107
Email address
maryamhhh806@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-12, 1398/11/23
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the of low-level laser photo biomodulation effect on enhancement of post Lefort I and sagittal split osteotomy surgery neurosensory deficits with clinical neurosensory testing (CNST)
Public title
Effect of low level laser therapy on paresthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy systemic status Age 18-30 Healthy neurological system informed consent Patients Candidate for orthognathic surgery
Exclusion criteria:
Any local or systemic disease Age under 18 and over 30 years History of trauma and jaw fracture History of previous maxillofacial surgery Taking muscle relaxant and sedative and anti-inflammatory drugs over the past 3 months Pregnancy Immune system defects Smoking Taking muscle relaxant and sedative and anti-inflammatory drugs over the past 3 months
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 12
More than 1 sample in each individual
Number of samples in each individual: 4
upper right jaw, upper left jaw, lower left jaw, lower right jaw
Randomization (investigator's opinion)
Randomized
Randomization description
Surgical areas (left or right) in each jaws (maxilla and mandible) are randomly divided into two groups (intervention and control) by coin flipping method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each operated jaws of the patients (maxilla or mandible) are randomly divided to right and left sides as intervention or control side (with coin flip) then the patients are treated unilateral with laser on and the other side with laser off without awareness of knowing the on or off of the device. Then after 1,3 months they are evaluated bilaterally with clinical neurosensory tests by the person who dont know about intervention or control side.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
8173955161
Approval date
2020-01-12, 1398/10/22
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.602

Health conditions studied

1

Description of health condition studied
Post-orthognathic surgery paresthesia
ICD-10 code
R20.2
ICD-10 code description
Paresthesia of skin

2

Description of health condition studied
Jaw deformity
ICD-10 code
M26
ICD-10 code description
Dentofacial anomalies [including malocclusion]

Primary outcomes

1

Description
Thermal
Timepoint
Before surgery, 2 and 3 months after surgery
Method of measurement
Visual Analogue Scale

2

Description
light touch
Timepoint
Before surgery, 2 and 3 months after surgery
Method of measurement
Visual Analogue Scale

3

Description
Pin prick
Timepoint
Before surgery, 2 and 3 months after surgery
Method of measurement
Visual Analogue Scale

4

Description
Two point discrimination
Timepoint
Before surgery, 2 and 3 months after surgery
Method of measurement
caliper

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: one side, called treated site will randomly choose for low level laser therapy by portable device (GaAlAs) in day 1, 5, 10 and 14 after orthognathic surgery. Exposure areas in lefort I candidates are 10 points in infra-orbital innervation entity between philtrum, lateral alar rim, lower lip, malar eminence and commissure lip line extension. exposure areas in mandible BSSO surgery are 7 points in IAN canal line between angle to menton (linear and 1 cm apart) and 9 points in mental erea (between mental foreman to midline).
Category
Treatment - Devices

2

Description
Control group: Orthognathic surgery without laser exposure. In the control group (other side) the device is in stand-by mode with no exposure (placebo effect) and the same points with the same duration are pretending to be irradiated as the treated side.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Taghi Hashemi
Street address
Kashani Ave.
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
kashani@mui.ac.ir

2

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Majid Rezvani
Street address
Hezar Jrib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
NakisaTorabinia
Street address
Hezar Jrib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5502
Email
pajouhesh@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Haghighat
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.81, Sharafaldin Ave., Shariati St.
City
Isfahan
Province
Isfehan
Postal code
8173955161
Phone
+98 31 3627 0107
Email
maryamhhh806@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Haghighat
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.81,Sharafaldin Ave., Shariati St.
City
Isfahan
Province
Isfehan
Postal code
8173955161
Phone
0098 32 36270107
Email
maryamhhh806@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Haghighat
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No.81, Sharafaldin Ave., Shariati St.
City
Isfahan
Province
Isfehan
Postal code
8173955161
Phone
+98 31 3627 0107
Email
maryamhhh806@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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