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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04824456
Enrollment
36
Registered
2021-04-01
Start date
2019-12-01
Completion date
2021-08-01
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSO

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.

Interventions

PROCEDUREbilateral 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Patient with skeletal malocclusion, class II or class III that is indicated for bilateral sagittal split osteotomy.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
neurosensory disturbance of the inferior alveolar nerve.1 yearuse 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

Secondary

MeasureTime frameDescription
Incidence of bad split1 yearif bad split in the mandible occur during the operation it will be reported
post operative edema ,1 yearpreoperative measure from the tragus to mid of the chin by cm then the measure is repeated to count the amount of edema
post operative pain1 yearby visual analogue scale from 0 to 10 and the patient choose the number

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026