NCT05385133

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

May 7, 2022

Last Update Submit

May 19, 2022

Conditions

Orthognathic Surgery

Outcome Measures

Primary Outcomes (1)

  • Condylar deviation

    Change of condyle position postoperative from preoperative position

    1 week postoperatively

Study Arms (2)

Computer guided condylar position

EXPERIMENTAL

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

Procedure: Computer guided condylar position

Manual condylar position

EXPERIMENTAL

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

Procedure: Manual condylar position

Interventions

Computer guided condylar positionPROCEDURE

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

Computer guided condylar position
Manual condylar positionPROCEDURE

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

Manual condylar position

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients require bi-maxillary orthognathic surgery
  • patients with temporomandibular joint dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2022

First Posted

May 23, 2022

Study Start

August 1, 2019

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)