Evaluation of the effect of low level laser on sensory disturbances after mandibular orthognatic surgery
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group design of 20 patients, from June 2018 for 6 months, including 20 patients
Settings and conduct
This double-blind randomized controlled trial was carried out on patients who were candidates of mandible orthognathic surgery and were referred to maxillofacial surgery ward of Sina and Shariati Hospitals affiliated to Tehran University of Medical Sciences, Iran.
Participants/Inclusion and exclusion criteria
patients included if underwent bilateral sagittal split mandibular ramus osteotomy. patients excluded if they reported underlying disease or past history of mandibular surgery.
Intervention groups
In intervention group laser used but in the control group the laser did not use.
Main outcome variables
neurosensory recovery; changes in visual analog scale (VAS) for general sensitivity; directional discrimination; 2-point discrimination; pain discrimination; thermal discrimination.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190513043579N1
Registration date:2019-06-09, 1398/03/19
Registration timing:retrospective
Last update:2019-06-09, 1398/03/19
Update count:0
Registration date
2019-06-09, 1398/03/19
Registrant information
Name
Mohammad mehdi Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7782 1713
Email address
hamedta90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-01, 1397/03/11
Expected recruitment end date
2019-01-31, 1397/11/11
Actual recruitment start date
2018-06-15, 1397/03/25
Actual recruitment end date
2019-01-15, 1397/10/25
Trial completion date
2019-03-15, 1397/12/24
Scientific title
Evaluation of the effect of photobiomodulation on neurosensory disturbances after sagittal osteotomy of mandible
Public title
Evaluation of the effect of low level laser on sensory disturbances after mandibular orthognatic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
no previous facial trauma or inferior alveolar nerve injury
no neurosensory disturbance before surgery
patients underwent osteotomy to correct the maxillofacial deformity
no consumption of analgesic, anticonvulsants and antidepressants medications
Exclusion criteria:
Patients with systemic diseases
patients with bad split or severe bleeding during the surgery
patients with obvious nerve damage during the surgery
patients with neuromuscular disorders
patients’ candidate for genioplasty
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Left and right side of every participant's mandible.
Actual sample size reached:
36
More than 1 sample in each individual
Actual sample size in each individual:
2
Left and right side of every participant's mandible.
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers were generated through computerized block randomization using SPSS software version 23.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and doctor who evaluated neurosensory recovery were blinded to the side of laser radiation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Dentistry school, Tehran University of Medical Sciences
Street address
North kargar St.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Approval date
2018-04-23, 1397/02/03
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1397.080
Health conditions studied
1
Description of health condition studied
neurosensory disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
neurosensory recovery
Timepoint
assessment of neurosensory recovery 1 and 30 and 60 days after the surgery
Method of measurement
neurosensory tests
Secondary outcomes
1
Description
General Sense
Timepoint
assessment of General Sense 1 and 30 and 60 days after the surgery
Method of measurement
Visual Analogue Scale
2
Description
Pain Sensation
Timepoint
assessment of Pain Sensation 1 and 30 and 60 days after the surgery
Method of measurement
Needle gauge 23
3
Description
Two Point Discrimination
Timepoint
assessment of Two Point Discrimination 1 and 30 and 60 days after the surgery
Method of measurement
surgical compass
4
Description
Thermal discrimination
Timepoint
assessment of Thermal discrimination 1 and 30 and 60 days after the surgery
Method of measurement
Ethyl chloride spray
5
Description
directional discrimination
Timepoint
assessment of directional discrimination 1 and 30 and 60 days after the surgery
Method of measurement
Clinical test by nylon thread
Intervention groups
1
Description
Laser irradiation was applied with a GaAs diode laser (Wiser; Doctor Smile–Lambda Spa, Brendola, Vicenza, Italy) (980 nm wavelength, power of 100 mW, and the energy density of 12 J/cm2). Laser irradiation was maintained within a 0.5 cm2 area. Laser energy was used for 60 sec in each visit.Unilateral extraoral LLL therapy was done one day before the surgery and then on the days 1, 3, 7, 14, 21, and 28 after the surgery. One side of the mandible was considered as the intervention side and the other side was considered as the control side. In the control side, laser probe with a red light was put on the considered area, but device was not activated, so that the patients were blinded to the side radiated by laser. In chin area, radiation was done on 6 points on each side from vermilion border to the lower border vertically and from midline to oral commissure horizontally. Then, radiation was appleid on 6 points in buccal region from oral commissure to lingula with a gentle pressure of laser probe.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Taheri
Street address
Keshavarz St
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
Tums_edu@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Taheri
Street address
Keshavarz St
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8131
Email
Tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Taheri
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 8 -no 41 Bozorgian st- Narmak
City
Tehran
Province
Tehran
Postal code
1645637179
Phone
+98 989171004971
Email
Hamedta90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Taheri
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 8 - no 41 - Bozorgian st -Narmak
City
Tehran
Province
Tehran
Postal code
1645637179
Phone
+98 982177821713
Email
Hamedta90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Taheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Unit 8 - No. 41- Bozorgian st- Narmak
City
Tehran
Province
Tehran
Postal code
1645637179
Phone
+98 21 7782 1713
Fax
Email
Hamedta90@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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