Condyle Repositioning Using PSI and Prebent Plates Osteosynthesis Versus Conventional Mandibular BSSO Set-back Surgery

NCT ID: NCT05385133

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-01-20

Brief Summary

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Patients with skeletal class III malocclusion were allocated to two groups. Both proximal and distal segments were repositioned using osteotomy/screw holes and plate locating surgical guides with pre-bent plates osteosynthesis in the intervention group, while manual free hand condylar segment seating was used for proximal segment positioning in the control group.

Detailed Description

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Twenty patients with skeletal class III malocclusion were randomly allocated to two groups. Both proximal and distal segments were repositioned using osteotomy/screw holes and plate locating surgical guides with pre-bent plates osteosynthesis in the intervention group, while manual free hand condylar segment seating was used for proximal segment positioning in the control group. Accuracy of condylar position was assessed using computed tomography.

Conditions

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Orthognathic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Computer guided condylar position

post-osteotomy condylar position was performed using patient specific surgical guides and pre-bent plates

Group Type EXPERIMENTAL

Computer guided condylar position

Intervention Type PROCEDURE

post-osteotomy condylar position was performed using patient specific surgical guides and pre-bent plates

Manual condylar position

post-osteotomy condylar position was performed using the conventional free hand approach

Group Type EXPERIMENTAL

Manual condylar position

Intervention Type PROCEDURE

post-osteotomy condylar position was performed using the conventional manual method

Interventions

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Computer guided condylar position

post-osteotomy condylar position was performed using patient specific surgical guides and pre-bent plates

Intervention Type PROCEDURE

Manual condylar position

post-osteotomy condylar position was performed using the conventional manual method

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patients complaining of skeletal class III malocclusion that require BSSO for correction of their deformity

Exclusion Criteria

* Patients require bi-maxillary orthognathic surgery
* patients with temporomandibular joint dysfunction
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sherif Ali

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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OMFS-14719

Identifier Type: -

Identifier Source: org_study_id

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