Evaluation of facial soft tissue asymmetric changes in patients after jaw surgery
ISRCTN | ISRCTN26961096 |
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DOI | https://doi.org/10.1186/ISRCTN26961096 |
- Submission date
- 17/09/2020
- Registration date
- 12/02/2021
- Last edited
- 06/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The appearance of the face is an important factor for humans, which affects self-esteem, and has psychological and social effects. Even a slight asymmetry following surgery may not satisfy the patient, due to increasing demands on facial appearance.
Previous reports on soft tissue changes and on long-term follow up after jaw surgery are limited. This study will specifically investigate changes following surgery to correct lower jaw protrusion, where the lower jaw is enlarged in comparison to the upper, also known as a cross-bite or skeletal Class III malocclusion.
The aim of this study is to investigate the changes in facial soft tissue asymmetry over time after jaw surgery in Class III patients, using 3-D imaging. The goal is to find how the asymmetry of facial soft tissue changes by 12 months after surgery. The study's findings should help to inform patients more precisely about the possible changes in facial soft tissues after the surgery.
Who can participate?
Adults over the age of 19 with skeletal Class III malocclusion.
What does the study involve?
Participants will undergo their scheduled orthodontic treatment and jaw surgery between 2011 to 2018. They will additionally have 3D facial images taken at three time points: before surgery, and at 6 months and 12 months after surgery.
What are the possible benefits and risks of participating?
There are no direct benefits to participants but the study will hopefully provide benefits to future patients, who can be better informed and manage expectations.
There is no additional risk to those taking part in the study because 3D stereophotogrammetry is a non-invasive method.
Where is the study run from?
Institute of Stomatology of the Rīga Stradiņš University (Latvia)
When is the study starting and how long is it expected to run for?
From April 2011 to December 2018
Who is funding the study?
Institute of Stomatology of the Rīga Stradiņš University (Latvia)
Who is the main contact?
Prof. Andris Ābeltiņš
Andris.Abeltins@rsu.lv
Contact information
Scientific
Dzirciema iela 20
Riga
LV-1007
Latvia
0000-0003-3983-315X | |
Phone | +371 29556417 |
andris.abeltins@rsu.lv |
Study information
Study design | Prospective cohort study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | No participant information sheet available |
Scientific title | Evaluation of facial soft tissue asymmetric changes in Class III patients after orthognatic surgery |
Study objectives | The asymmetry of the facial soft tissues decreases after orthognathic surgery. |
Ethics approval(s) | Approved 26/04/2012, Ethics Committee of the Rīga Stradiņš University (RSU) (Riga, Dzirciema iela 16, LV-1007; +371 67409101), ref: E-9 (2) |
Health condition(s) or problem(s) studied | Facial soft tissue asymmetric changes following orthodontic treatment and orthognathic surgery |
Intervention | The cohort will be recruited from patients treated at the Department of the Orthodontics, Institute of Stomatology of the Rīga Stradiņš University. The mean follow-up for these patients is at least 12 months. All patients receive orthodontic treatment and orthognathic surgery. Images for all of the involve patients acquire using the 3dMDtrio (3dMD, Atlanta, GA) stereophotogrammetric system, to assess facial soft tissue dimensions. 3-dimensional photographs of all patients record: before surgery (T0), 6 months (T1) and 12 months (T2) after surgery. The acquire images load to the 3dMDvultus, version 2.5.0.1. Program (3dMD, LLC) and analyz from all angles in 3 coordinates –x, y and z . The 21 anthropometric landmarks are digitally marked on each 3D facial surface at 3 time points: before surgery (T0), 6 months (T1) and 12 months (T2) after surgery. Further, the quantitative determination of facial asymmetry is performed with 3D data from each patient with mirroring approach. All three images of each patient are superimposed with their reflecting surfaces on stable anatomical surfaces. The program automatically measure the shortest distance between the original and mirrored surfaces and landmarks, using the 3D coordinates. The surface based method is used. |
Intervention type | Procedure/Surgery |
Primary outcome measure | 1. Asymmetric changes in soft-tissue are evaluated using the three-dimensional 3dMDtrio (3dMD, Atlanta, GA) stereophotogrammetric system at baseline, 6, and 12 months |
Secondary outcome measures | 1. The changes in facial asymmetry were compared between the following demographics using the three-dimensional stereophotogrammetric system at baseline, 6, and 12 months: 1.1. Time of image collection (before surgery/6 months after surgery/12 months after surgery) 1.2. Gender (Male/Female) 1.3. Type of surgery (single jaw, LeFort I/both jaw, bimaxillary) 1.4. Facial region groups |
Overall study start date | 20/04/2011 |
Completion date | 20/12/2018 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 101 |
Total final enrolment | 101 |
Key inclusion criteria | 1. Presence of skeletal Class III malocclusion (mandibular prognathism or maxillary retrognathism, or combination) 2. No history of trauma or maxillofacial surgery, or recognized craniofacial syndromes as etiologic factors 3. No active growth at the time of surgery 4. Received preoperative and post-operative orthodontic treatment 5. Underwent a single or both jaw surgeries during the time period of 2011- 2018 at the Department of the Orthodontics, Institute of Stomatology of the Rīga Stradiņš University 6. All 3D facial images for all 3 time points collected 7. Aged ≥19 years |
Key exclusion criteria | 1. Cleft or other craniofacial anomalies or syndromes 2. Beards and/ or mustaches at any time point 3. One of the 3D images was defective (for example, the head was moved during image capture, resulting in duplication of the image). |
Date of first enrolment | 05/10/2011 |
Date of final enrolment | 06/08/2018 |
Locations
Countries of recruitment
- Latvia
Study participating centre
Dzirciema iela 20
Riga
LV- 1007
Latvia
Sponsor information
University/education
Institute of Stomatology
Dzirciema iela 20
Riga
LV-1007
Latvia
Phone | +371 29556417 |
---|---|
andris.abeltins@rsu.lv | |
Website | http://www.rsu.lv/eng/ |
https://ror.org/03nadks56 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Rīga Stradiņš University, Rīga Stradiņš University, Universitas Rigensis Stradina, Riga Medical Institute, Medical Academy of Latvia, RSU
- Location
- Latvia
Results and Publications
Intention to publish date | 02/01/2021 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Other |
Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | 21/07/2022 | 06/10/2022 | Yes | No |
Editorial Notes
06/10/2022: Publication reference added.
14/10/2020: Trial’s existence confirmed by the Ethics Committee of the Rīga Stradiņš University (RSU).