Changes in facial soft tissue asymmetry in Class II patients after orthognathic surgery
| ISRCTN | ISRCTN14166937 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14166937 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Riga Stradiņš University |
| Funder | Rīgas Stradiņa Universitāte |
- Submission date
- 10/05/2024
- Registration date
- 13/05/2024
- Last edited
- 23/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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 long-term follow-up after jaw surgery are limited.
The aim of this study is to investigate the changes in facial soft tissue asymmetry over time after jaw surgery in Class II malocclusion patients using 3D imaging. The goal is to find how the asymmetry of facial soft tissue changes at 12 months after surgery and long-term changes after 3-5 years. 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 20 years with skeletal Class II malocclusion (where the upper teeth are too far forward compared to the lower teeth)
What does the study involve?
Participants will undergo their scheduled orthodontic treatment and jaw surgery between 2011 and 2021. They will additionally have 3D facial images taken at several timepoints: before surgery, 3-6 months, 9-12 months, 18 months, 2 years and 3-5 years after orthognathic 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 facial images are not invasive.
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?
November 2011 to March 2024
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
Public, Scientific, Principal investigator
Dzirciema iela 20
Riga
LV-1007
Latvia
 ORCID ID |
0000-0003-3983-315X |
|---|---|
| Phone | +371 (0)29556417 |
| andris.abeltins@rsu.lv |
Scientific
Dzirciema iela 20
Riga
LV-1007
Latvia
| ORCID ID |
0000-0002-0392-0078 |
|---|---|
| Phone | +371 (0)29556417 |
| edmonda.nike@rsu.lv |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective longitudinal cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Changes in facial soft tissue asymmetry in Class II patients after orthognathic surgery using three-dimensional stereophotogrammetry |
| Study objectives | 1. The asymmetry of the facial soft tissues in patients with skeletal class II decreases after orthognathic surgery. 2. Patients with greater facial soft tissue asymmetry before surgery have a higher risk of facial soft tissue relapse in the long term (after surgery). All faces are asymmetric to some degree. This is a particular interest when evaluating orthognathic surgery (OGS) outcomes. With orthognathic patients, surgery is principally conducted to reduce asymmetry, but there is also the possibility that surgery may inadvertently increase it (Vittert et al., 2018). Soft tissue response after surgery and symmetry are only partially predictable and have tremendous individual variation response, especially in the maxillary and midfacial region (Gill et al., 2017). Facial soft tissue asymmetric changes in the long term will be assessed for Class II and III malocclusion patients after orthodontic treatment and orthognathic surgery. Three-dimensional photographs of all patients were recorded and the position of 21 landmarks was evaluated at six timepoints: before surgery (T0), 3-6 months (T1), 9-12 months (T2), 18 months (T4), 2 years (T5) and 3-5 years (T6) after orthognathic surgery. |
| Ethics approval(s) |
Approved 26/04/2012, Ethics Committee of the Rīga Stradiņš University (RSU) (Dzirciema Street 16, Riga, LV-1007, Latvia; +371 (0)67409101; pek@rsu.lv), ref: E-9 (2) |
| Health condition(s) or problem(s) studied | Orthognathic surgery |
| Intervention | The cohort will be recruited from patients treated at the Department of Orthodontics, Institute of Stomatology of the Rīga Stradiņš University. The mean follow-up for these patients is at least 36 months. All patients receive orthodontic treatment and orthognathic surgery. Images for all of the involved patients are acquired using the 3dMDtrio (3dMD, Atlanta, GA) stereophotogrammetric system to assess facial soft tissue dimensions. Three-dimensional photographs of all patients are recorded before surgery (T0) and at 6 months (T1), 12 months (T2), 18 months (T3), 2 years (T4) and 3-5 years (T5) after surgery. The acquired images are loaded to the 3dMDvultus, version 2.5.0.1. Program (3dMD, LLC) and are analysed from all angles in three coordinates: x, y and z. The 21 anthropometric landmarks are digitally marked on each 3D facial surface at all timepoints. Further, the quantitative determination of facial asymmetry is performed with 3D data from each patient with a mirroring approach. All images of each patient are superimposed with their reflecting surfaces on stable anatomical surfaces. The program automatically measures 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(s) |
Asymmetric changes in soft-tissue evaluated using the three-dimensional 3dMDtrio (3dMD, Atlanta, GA) stereophotogrammetric system before surgery (T0), 6 months (T1) and 12 months (T2), 18 months (T3), 2 years (T4) and 3-5 years (T5) after surgery |
| Key secondary outcome measure(s) |
1. Changes in facial asymmetry compared between the following demographics using the three-dimensional stereophotogrammetric system before surgery (T0), 6 months (T1) and 12 months (T2), 18 months (T3), 2 years (T4) and 3-5 years (T5) after surgery: |
| Completion date | 11/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 22 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 55 |
| Total final enrolment | 75 |
| Key inclusion criteria | 1. Presence of skeletal Class II malocclusion 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- 2021 at the Department of the Orthodontics, Institute of Stomatology of the Rīga Stradiņš University 6. All 3D facial images for all timepoints collected 7. Aged ≥22 years |
| Key exclusion criteria | 1. Cleft or other craniofacial anomalies or syndromes 2. Beards and/or mustaches at any timepoint 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 | 03/07/2012 |
| Date of final enrolment | 10/12/2021 |
Locations
Countries of recruitment
- Latvia
Study participating centre
Dzirciema iela 20
Riga
LV- 1007
Latvia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| 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? |
|---|---|---|---|---|---|
| Results article | 23/04/2025 | 23/04/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/04/2025: Publication reference added.
06/11/2024: The following changes were made:
1. The public title was changed from "Evaluation of facial soft tissue asymmetric changes in patients after jaw surgery".
2. The scientific title was changed from "Evaluation of facial soft tissue asymmetric changes in Class II and Class III patients after orthognathic surgery using three-dimensional stereophotogrammetry".
13/05/2024: Study's existence confirmed by the Ethics Committee of the Rīga Stradiņš University.
