| CTRI Number |
CTRI/2019/11/021981 [Registered on: 13/11/2019] Trial Registered Prospectively |
| Last Modified On: |
29/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An experiment to compare the efficency of laser and medicine (pregbalin) in recovery of nerve deficits in patients undergoing operation for maxillofacial trauma. |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy of Low Level Diode Laser Therapy and Conventional Medical Therapy in Recovery of Infraorbital or Inferior Alveolar Neurosensory Deficits in Participants Undergoing Open Reduction and Internal Fixation for Maxillofacial Trauma - A Prospective Randomized Observer Blind Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prachi M Goyal |
| Designation |
2nd year post-graduate(MDS) student |
| Affiliation |
MGM Dental College and Hospital, Navi Mumbai |
| Address |
Oral and Maxillofacial Department, MGM Dental college and hospital
Raigarh
MAHARASHTRA
410209
India |
| Phone |
7738931660 |
| Fax |
|
| Email |
prachigoyal3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Asnani |
| Designation |
Professor |
| Affiliation |
MGM Dental College and Hospital, Navi Mumbai |
| Address |
Oral and Maxillofacial Department, MGM Dental college and hospital.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9820897181 |
| Fax |
|
| Email |
drushaasnani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSrivalli Natarajan |
| Designation |
Professor and HOD |
| Affiliation |
MGM Dental College and Hospital, Navi Mumbai |
| Address |
Oral and Maxillofacial Department, MGM Dental college and hospital.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9769088803 |
| Fax |
|
| Email |
srivallis@hotmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Dental College and Hospital,Junction of NH4 and, Sion - Panvel Expy, Sector 18, Navi Mumbai, Maharashtra 410209 |
|
|
Primary Sponsor
|
| Name |
MGM Dental College and Hospital Navi Mumbai |
| Address |
Dept of Oral and Maxillofacial surgery, MGM Dental college, Kamothe, Navi Mumbai, Sector 18, Maharashtra: 410209. |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPrachi Goyal |
MGM dental college and hospital |
room no. 3,Dept of Oral and Maxillofacial surgery, MGM Dental college, Kamothe, Navi Mumbai, Sector 18, Maharashtra: 410209.
Raigarh
MAHARASHTRA |
7738931660
prachigoyal3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,MGM Dental College And Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low level diode laser therapy |
Laser therapy will be initiated 48 hours post operatively with the following laser protocol and will be continued on 4th ,6th, 8th, 10th, 14th, 21st, and 28th day counting for 2 to 3 sessions per week for atleast 8-10 sessions. Interval of 48 hours will be maintained in between each session.it will be done externally on face and also intraorally on mandibular foramen site.
Laser irradiation specifications:
1) Infrared range of the spectrum (810 nm)
2) Spot size of 1 cm2
3) Method of beam emission will be continuous wave.
4) Output power of 100 mW (0.1W)
5) Energy density of 6 J/cm2
6) Exposure time/point of 28 sec for one spot
7) Energy per point of 6 J
8) Distance between points of irradiation from 1.0 to 1.5 cm.
|
| Comparator Agent |
medicine group |
Medicine details:
(Fda number-21-724)
Tab.Pregabalin (Lyrica)– 75 mg Once daily in morning for 6 weeks through oral route.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Participants of both the genders between age group of 18-60 years.
2) Participants with post traumatic neurosensory disturbances of infraorbital or inferior alveolar nerves in unilateral facial fractures requiring open reduction and internal fixation.
3) Participants willing for the study and follow up.
|
|
| ExclusionCriteria |
| Details |
1) Isolated zygomatic arch and condylar process fractures.
2) Participants with neurologic disorder like seizures.
3) Participants with systemic diseases such as diabetes, Thyroid disorders, carcinomas, on steroids etc.
4) Pregnant females.
5) Participants with a history of head injury, Uncooperative and mentally retarded participants.
6) Isolated soft tissue lacerations and avulsion injuries
|
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the effectiveness of low level diode laser therapy(LLLT) and conventional medical therapy using two point discrimination , pin prick stimuli and thermal discrimination conducted on various intervals upto 6 months for recovery of infraorbital or inferior alveolar neurosensory deficits. |
24 hours prior to surgery, 48hrs after surgery, 7th day, after 1 month, 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Degree of neurosensory deficit of infraorbital and inferior alveolar nerve.
2) Progress of recovery of neurosensory deficit of infraorbital and inferior alveolar nerve.
|
24 hours prior to surgery, 48hrs after surgery, 7th day, after 1 month, 3 months and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/11/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
i intend to publish this study in the article format after completion |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
This is a randomized , observer blind study in which two groups of patients are recruited depending upon the treatment modality the patient is going to be subjected to be. Followed by that clinical nerve sensory testing will be performed at various intervals and outcomes will be recorded. |