An experiment to compare the efficency of laser and medicine (pregbalin) in recovery of nerve deficits in patients undergoing operation for maxillofacial trauma.

Phase 4

Active, not recruiting

• Conditions: Other intraoperative and postprocedural complications and disorders of nervous system,

• Registration Number: CTRI/2019/11/021981
• Lead Sponsor: MGM Dental College and Hospital Navi Mumbai

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-15
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
1) Degree of neurosensory deficit of infraorbital and inferior alveolar nerve.	2) Progress of recovery of neurosensory deficit of infraorbital and inferior alveolar nerve.

Trial Locations

Locations (1)

MGM dental college and hospital; 🇮🇳 Raigarh, MAHARASHTRA, India

MGM dental college and hospital

🇮🇳Raigarh, MAHARASHTRA, India

DrPrachi Goyal

Principal investigator

7738931660

prachigoyal3@gmail.com