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

to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSO Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04824456
• Other study ID #: 15460
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: August 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSO

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of bad split	if bad split in the mandible occur during the operation it will be reported	1 year
Secondary	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
Secondary	post operative pain	by visual analogue scale from 0 to 10 and the patient choose the number	1 year