Comparing the impact of slow and rapid maxillary expansion on the upper airway
| ISRCTN | ISRCTN10853186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10853186 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2904 |
| Sponsor | Damascus University |
| Funder | Damascus University |
- Submission date
- 27/10/2023
- Registration date
- 09/11/2023
- Last edited
- 09/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Transverse maxillary deficiency is a condition where the upper jaw (maxilla) is narrower than it should be. Is is commonly observed in daily clinical practice, often accompanied by a narrowing of the nasal airway. Several methods have been used to expand the upper maxilla and treat this condition, including slow maxillary expansion with light force and rapid maxillary expansion. Several studies have highlighted the role of rapid maxillary expansion in increasing the size of the nasal cavity and improving respiratory airway volume. However, the role of slow maxillary expansion still requires further investigation and study to determine its effectiveness in achieving similar outcomes. Additional research is needed to explore the effects of slow maxillary expansion on the nasal airway and respiratory function.
Who can participate?
Patients aged 8-11 years with transverse maxillary deficiency
What does the study involve?
Patients are randomly allocated to slow maxillary expansion or rapid maxillary expansion. In the slow expansion group, the Hyrax expander is applied and activated twice a week. In the rapid expansion group, the Hyrax expander is applied and activated twice a day.
What are the possible benefits and risks of participating?
The benefits include determining whether slow maxillary expansion has a similar effect on increasing respiratory airway volume as rapid maxillary expansion, which has more side effects. The potential risks are discomfort or pain during the process, gingival (gum) irritation, temporary speech changes, and root resorption.
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 May 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Mahmoud Alzarie, mahmoud.alzar3i@damascusuniversity.edu.sy
Contact information
Public, Scientific, Principal investigator
Almazzeh Street
Damascus
80789
Syria
| Phone | +963 (0)994211357 |
|---|---|
| mahmoud.za96@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | In patients with maxillary transverse deficiency, what are the effects of slow maxillary expansion compared to rapid maxillary expansion on upper airways as measured by cone beam computed tomography? |
| Study objectives | Null hypothesis: There is no significant difference in the effects on upper airways, as measured by cone beam computed tomography (CBCT), between slow maxillary expansion and rapid maxillary expansion in patients with maxillary transverse deficiency. Alternative hypothesis: Slow maxillary expansion has different effects on upper airways compared to rapid maxillary expansion in patients with maxillary transverse deficiency, as measured by CBCT. |
| Ethics approval(s) |
Approved 06/06/2022, Scientific research and postgraduate studies council of Damascus University (-, Damascus, 80789, Syria; +963 (0)993303359; ap.srd@damascusuniversity.edu.sy), ref: 2904 |
| Health condition(s) or problem(s) studied | Transverse maxillary deficiency |
| Intervention | Patients are randomly selected using a simple manual method, where each patient was asked to draw an envelope containing either Model 1 or Model 2, and then write their name on the envelope they selected, keeping it sealed and hidden from the researcher to ensure unbiased distribution. Based on this, the distribution was as follows: In 1: Slow maxillary expansion group. In 2: Rapid maxillary expansion group. In the slow expansion group, the Hyrax expander is applied, and the expander is activated twice a week. In the rapid expansion group, the Hyrax expander is applied, and the expander is activated twice a day. The treatment duration is 6 months with no follow-up. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Changes in the upper airways measured using CBCT at T0 before applying device and at T1 after applying the device for 6 months |
| Key secondary outcome measure(s) |
The following distances were measured perpendicular to CorPL and SrPL at T0 (before applying the device) and T1 (after applying the device for 6 months) |
| Completion date | 15/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 11 Years |
| Sex | All |
| Target sample size at registration | 38 |
| Key inclusion criteria | 1. Patients aged 8-11 years 2. Maxillary transverse constriction |
| Key exclusion criteria | 1. Patients with systemic diseases or craniofacial syndromes 2. Patients with poor oral health 3. Patients with dental crossbite |
| Date of first enrolment | 18/07/2022 |
| Date of final enrolment | 15/10/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Syria
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| 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
09/11/2023: Study's existence confirmed by the Damascus University Chairman (Syria).
