NCT03687307

Brief Summary

the aim of the study is to establish reference data that could be used for the creation of more accurate three dimensional prediction of soft tissue outcome.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 26, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

September 26, 2018

Last Update Submit

October 3, 2018

Conditions

Orthognathic Surgery

Keywords

class II,soft tissue changesCBCT

Outcome Measures

Primary Outcomes (1)

  • 3D soft-tissue changes (linear)

    the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery

    6 months

Secondary Outcomes (4)

  • Proportion of soft tissue change to hard tissue change

    6 months

  • Is the esthetic outcome as expected/imagined?

    6 months

  • 3D soft-tissue changes (angular)

    6 months

  • 3D soft-tissue changes (volumetric)

    6 months

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with class 2 skeletal deformity, over 18 years and younger than 40

You may qualify if:

  • Patients with class II skeletal deformity
  • Patients must be over 18 years of age to allow for growth cessation
  • Patients must not have any systemic condition which contraindicates general anaesthesia

You may not qualify if:

  • o patients with cleft palate
  • patients with syndromes affecting their craniofacial structure
  • patients with facial scars
  • patients with severe facial asymmetry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 26, 2018

First Posted

September 27, 2018

Study Start

February 1, 2019

Primary Completion

August 1, 2020

Study Completion

August 1, 2021

Last Updated

October 4, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share