Neurosensory Assesment After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT

Evaluation of Neurosensory Disturbance After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT

The bilateral sagittal split Ramus osteotomy (BSSRO) was introduced by Trauner and Obwegeser. Since then, many modifications of this procedure have been reported, leading to a less difficult and more predictable procedure for correcting mandibular anomalies. persistent post-operative neurosensory disturbances of the inferior alveolar nerve are still one of the major complications of this operation. The incidence has decreased over the years due to improved techniques and the use of different instruments. However, most recent series still report postoperative persistent hypesthesia of the inferior alveolar nerve in more than 10% of the patients up to 48%.

There are no reports on the influence of other surgical variables on the persisting post-operative hypesthesia. Several methods have been reported for evaluating neurosensory disturbances of the inferior alveolar nerve. One of the simplest methods reported is tactile evaluation based on subjective sensation reported by the patients. Many authors have used this method in their evaluation of post-operative hypesthesia.

Study Overview

• Status: Unknown
• Conditions: to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSO
• Intervention / Treatment: Procedure: bilateral sagittal split osteotomy using separators.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12345
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

IInclusion criteria:

1. Patient with skeletal malocclusion, class II or class III that is indicated for bilateral sagittal split osteotomy.
2. Adults >18 years.
3. Systemically healthy.

Exclusion criteria:

1. Patients not indicated for orthognathic surgery.
2. Severe systemic disease.
3. Have a medical condition associated with systemic neuropathy (e.g. diabetes)
4. Patients whom cannot tolerate follow up intervals. (affect accuracy of study results)
5. Are unwilling to sign informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bilateral sagittal split osteotomy using chisels.; The final split is completed with Smith forceps and flag separators	Procedure: bilateral sagittal split osteotomy using separators.; The final split is completed with a thin osteotomes, splitting the entire ascending ramus from the anterior to the posterior border of the ramus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurosensory disturbance of the inferior alveolar nerve.	use Von Frey filaments to test sensory function of the lower lip and two point discrimination test (blunt and sharp ) also to assess the sensory function	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bad split	if bad split in the mandible occur during the operation it will be reported	1 year
post operative edema ,	preoperative measure from the tragus to mid of the chin by cm then the measure is repeated to count the amount of edema	1 year
post operative pain	by visual analogue scale from 0 to 10 and the patient choose the number	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: March 27, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 27, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 15460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No