Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite

Not Applicable

• Conditions: Apertognathia

• Registration Number: NCT03277443
• Lead Sponsor: Ammar Ribhi Abu shama

Brief Summary

In patient with skeletal open bite, Dose computer-aided surgery enhances the clinical outcomes and accuracy versus conventional model surgery

Detailed Description

P Adult Patients with skeletal open bite.

I Computer guided surgery.

C Conventional articulating model surgery

O Outcome measure:

Outcome Name Measuring Device Measuring Unit (mm)

O1 Accuracy

Computer guided: Super-imposition of virtual surgery over the post- operative CT Scan composite models ( millimeter mm)

Conventional : Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion ( millimeter mm)

O2 Anterior open Bite Closure

Standardized Multi Scan CT (millimeter mm)

Study Timeline

• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14
• Study Start: 2018-02-20
• Primary Completion: 2018-12-30
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Patients suffering from skeletal open bite caused by vertical posterior maxillary excess and/or short mandible ramus.
• Patients should be free from any systemic disease that may affect normal healing, and predictable outcome.
• Required two jaws orthographic surgery

Exclusion Criteria

• Patients with any systemic disease that may affect normal healing
• Intra-bony lesions or infections that may retard the osteotomy healing.
• Patient with bad oral hygiene.
• Uncontrolled Diabetes mellitus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Accuracy of movement of surgical segments in millimeter	up to 4 months	Computer guided Super-imposition of virtual surgery over the post- operative CT Scan composite models (millimeter mm).; Conventional Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion- accuracy would be compared by difference between Intervention and control in (millimeter mm).

Secondary Outcome Measures

Name	Time	Method
Anterior open Bite Closure (positive overbite in millimeter)	up to 4 months	Standardized pre-surgery movement in amount of anterior open bite closure (mm) will be determined clinically and by radiograph.