Purpose: In this study, we investigated the effect of Low Lever Laser Therapy (LLT) and Light-Emitting Diode (LED) on Inferior Alveolar Nerve regeneration/recovery after bilateral sagittal split osteotomy.
Design: In this double-blinded study we considered 20 patients with Inferior Alveolar Nerve injury after bilateral sagittal split osteotomy of the mandible at Taleghani Hospital as study population. Patients were randomized into two equal groups: control and intervention. Inclusion Criteria: Inferior Alveolar nerve injury after bilateral sagittal split osteotomy (Neurapraxia, Sanderland I, II). Exclusion Criteria: Neurosensory disturbance, taking antipsychotic drugs, previous facial bone fracture, bad split, inferior alveolar nerve injury more than Neurapraxia. Intervention: 10 patients were given LLLT and LED. Emitting Low Level Laser and LED on inferior alveolar nerve of intervention group was done during 6 sessions ( 24 hours, 2 days, 3 days, 7 days, 14 days and 28 days after surgery). Primary outcome variable: Neurosensory deficit . Secondary outcome variable: Neurosensory Recovery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015053022471N2
Registration date:2015-08-15, 1394/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-15, 1394/05/24
Registrant information
Name
Mehdi Bemanali
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21230311
Email address
m.bemanali@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-08-30, 1393/06/08
Expected recruitment end date
2014-10-30, 1393/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of low level laser therapy and LED on inferior alveolar nerve regeneration or recovery after sagittal split osteotomy of mandible
Public title
Effects of photo therapy on neurosensory disturbance of the chin.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Nerve injures after Bilatteral sagittal Split Osteotomy (sanderlandII,II)
Exclusion: neurosensory deficit; precedent headache; retardation; neurologic disorder; collagen or vascular disease; previous facial fracture;type 1 diabetes ; bad split; genioplasty
Age
From 20 years old to 29 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences (Vice- Chancellor in International Affairs)
Street address
Shahid Arabi St, Yaman St, Shahid Chamran Exp, Tehran
City
Tehran
Postal code
Iran
Approval date
2014-10-12, 1393/07/20
Ethics committee reference number
1000/683 (Vice- Chancellor in International Affairs)
Health conditions studied
1
Description of health condition studied
Nerusensory deficit after Orthognathic surgery
ICD-10 code
Z09.0
ICD-10 code description
Follow-up examination after surgery for other conditions
Primary outcomes
1
Description
Nerosensory deficit
Timepoint
preoperative, 1 day , 3days , 7 days , 14 days, 2 months, 6 months after surgery
Method of measurement
Examiniation
Secondary outcomes
1
Description
Nerosensory Recovery
Timepoint
preoperative, 1 day , 3days , 7 days , 14 days, 2 months, 6 months after surgery
Method of measurement
Examination
Intervention groups
1
Description
Intervention:
Emitting Low Level Laser and LED on inferior alveolar nerve during 6 sessions ( 24 hours, 2 days, 3 days, 7 days, 14 days and 28 days after surgery)
Category
Rehabilitation
2
Description
Control:
No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Mehdi Bemanali
Street address
Taleghani Hospital, Shahid Arabi St., Yaman St., Chamran Exp, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyyed Hassan Mohajerani
Street address
Taleghani hospital, Shahid Araabi st, Yaman St, Chamran Exp, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mehdi Bemanali
Position
Resident of Oral and Maxillofacial surgery
Other areas of specialty/work
Street address
Taleghani Hospital, Shahid Arabi St. , Yaman St., Chamran Exp., Tehran
City
Tehran
Postal code
Phone
+98 21230311
Fax
Email
m.bemanali@sbmu.ac.ir mehdi.bemanali@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyyed Hassan Mohajerani
Position
Associate professor
Other areas of specialty/work
Street address
Department of Oral and Maxillofacial Surgery, Taleghani hospital, Shahid Arrabi St., Yaman St., Chamran Exp., Tehran
City
Tehran
Postal code
Phone
+98 21230311
Fax
Email
mohajeranih@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mehdi Bemanali
Position
resident of oral and maxillofacial surgery
Other areas of specialty/work
Street address
Oral and Maxillofacial Surgery Department, Taleghani Hospital, Shahid Arabi St., Yaman St., Chamran Exp, Tehran
City
Tehran
Postal code
Phone
+98 21230311
Fax
Email
m.bemanali@sbmu.ac.ir mehdi.bemanali@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)