How to predict the success of rapid maxillary expansion
| ISRCTN | ISRCTN31077190 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31077190 |
| Secondary identifying numbers | 3215 |
- Submission date
- 21/10/2023
- Registration date
- 25/10/2023
- Last edited
- 25/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Rapid maxillary expansion (RME) is a common orthodontic treatment to correct transverse maxillary deficiency, where the upper jaw (maxilla) is narrower than it should be. Transverse discrepancies should be treated as soon as possible. There is still debate about what age the RME procedure would be ineffective and the only solution would be surgical-assisted RME (SARME). On the other hand, a preference for surgery in a case that could be treated without surgical assistance would make the patient suffer from an unnecessary operation which is invasive, costly, and involves surgical risks. This study aims to evaluate the indicators that predict the success of RME using cone beam CT (CBCT) scans.
Who can participate?
Patients aged 14-18 years with transverse maxillary deficiency
What does the study involve?
All participants undergo a CBCT scan before they undergo RME. According to a scan taken 4 days after the beginning of the RME procedure, patients are allocated into two groups: successful RME and failed RME. Five CBCT variables are evaluated to predict the success of RME.
What are the possible benefits and risks of participating?
All participants are made aware of the risks of the RME procedure. The risks include mucosal ulceration or necrosis, accentuated buccal tooth tipping, gingival recession and severe pain around the posterior teeth. Patients who had a successful RME continue their treatment as planned while patients in the failed RME group will complete the procedure by surgical-assisted rapid maxillary expansion (SARME).
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
June 2022 to June 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Mahmood Aleesh, mahmood.aleesh@damascusuniversity.edu.sy
Contact information
Public, Scientific, Principal Investigator
Al-Mazzeh Street
Damascus
80789
Syria
| Phone | +963 (0)962816417 |
|---|---|
| mahmood.aleesh@damascusuniversity.edu.sy |
Study information
| Study design | Prospective clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Dental clinic |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation of indicators which predict the success of rapid maxillary expansion using cone beam computed tomography |
| Study hypothesis | Null hypothesis: There are no statistically significant differences in the degree of maturity of the median palatine suture on the cone beam computed tomography (CBCT) image between the group in which expansion was determined and the group in which it failed. Alternative hypothesis: There are statistically significant differences in the degree of maturity of the median palatine suture on the CBCT image between the group that performed rapid maxillary expansion and the group that failed. |
| Ethics approval(s) |
Approved 04/07/2022, Scientific research and postgraduate studies council of Damascus University (Damascus, Syria, Damascus, 80789, Syria; +963 (0)993303359; ap.srd@damascusuniversity.edu.sy), ref: 3215 |
| Condition | Skeletal cross bite |
| Intervention | The sample frame has been obtained by checking patients who came into the orthodontic department at Damascus University and got diagnosed with posterior skeletal crossbite, between the ages of 14-18 years. All patients who agreed to be a part of the research were asked to take a CBCT full skull radiograph before they undergo a rapid maxillary expansion (RME). According to the occlusal radiograph taken 4 days after the beginning of the RME procedure which indicates the response of the midpalatal suture, patients were allocated into two groups according to expansion success: Group 1: successful (S-RME) Group 2: failed (F-RME) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Success of skeletal rapid maxillary expansion, measured by the following indicators using CBCT at a single timepoint: 1. Midpalatal Suture Maturation (MSM) 2. The length and thickness of the midpalatal suture 3. Midpalatal Suture Desity (MSD) 4. Cervical Vertebral Maturation (CVM) 5. The position of the upper jaw in the vertical plane based on the points anterior nasal spine (ANS) and posterior nasal spine (PNS) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/06/2022 |
| Overall study end date | 05/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 14 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Participant inclusion criteria | 1. Patients in the permanent occlusion stage aged between 14-18 years 2. Transverse maxillary deficiency (posterior skeletal crossbite) 3. No tooth loss 4. Good oral health |
| Participant exclusion criteria | 1. Dental posterior crossbite 2. previous orthodontic treatment 3. The presence of extensive metal restorations in the teeth 4. The presence of periodontal diseases 5. The presence of cleft palate |
| Recruitment start date | 04/04/2023 |
| Recruitment end date | 10/02/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Faculty of Dentistry
Al-Mazzeh St.
Damascus
80789
Syria
Sponsor information
University/education
Mazzeh Street
Damascus
80789
Syria
| Phone | +963 (11) 339 23223 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 12/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and analyzed during the current study during this study will be included in the subsequent results publication. |
Editorial Notes
25/10/2023: Study's existence confirmed by Damascus University.
