ClinicalTrials.gg
CompletedNCT05385133Updated May 23, 2022

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

An interventional study of Computer guided condylar position and Manual condylar position in Orthognathic Surgery, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2022-05-23.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Aug 2019, registered May 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
17 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Orthognathic Surgery
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients require bi-maxillary orthognathic surgery
  • patients with temporomandibular joint dysfunction
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Computer guided condylar position

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

    Procedure: Computer guided condylar position

  • Experimental
    Manual condylar position

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

    Procedure: Manual condylar position

Interventions

  • ProcedureComputer guided condylar position

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

  • ProcedureManual condylar position

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

06

What researchers measure

Primary outcomes

  1. Condylar deviation

    Change of condyle position postoperative from preoperative position

    Time frame: 1 week postoperatively

07

Study locations

1 site
  • Faculty of Dentistry
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2019 to primary completion in Jan 2022, 29 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2022
First posted
May 23, 2022
StartActual
Aug 1, 2019
Primary completionActual
Jan 20, 2022
CompletionActual
Jan 20, 2022
Last update
May 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05385133
Lead sponsor
Cairo University
Responsible party
Sherif Ali (Associate Professor, Cairo University) — Principal investigator
First posted
May 23, 2022
Start date
Aug 1, 2019
Primary completion
Jan 20, 2022
Completion
Jan 20, 2022
Last update
May 23, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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