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

NCT ID: NCT04824456

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-08-01

Brief 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.

Conditions

to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSO

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

bilateral sagittal split osteotomy using chisels.

The final split is completed with Smith forceps and flag separators

Group Type: EXPERIMENTAL

bilateral sagittal split osteotomy using separators.

Intervention Type: PROCEDURE

The final split is completed with a thin osteotomes, splitting the entire ascending ramus from the anterior to the posterior border of the ramus.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hisham Mohammed Abdllfattah

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry

Cairo, , Egypt

Countries

Egypt

Other Identifiers

15460

Identifier Type: -

Identifier Source: org_study_id