Evaluation of oxygen and serum levels of growth hormone and bone growth after orthodontic treatment in growing patients
| ISRCTN | ISRCTN34963223 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34963223 |
| Secondary identifying numbers | Pro |
- Submission date
- 11/05/2023
- Registration date
- 31/05/2023
- Last edited
- 14/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
There are two treatment options for children with a crossbite in the back teeth. The first treatment includes the placement of an expansion appliance that attaches to the upper back teeth followed by having the child wear braces. The second option includes following the child until their permanent (adult) teeth come and then treating the crossbite with the expansion appliance and braces at that point. This study aims to determine if the expansion of the upper jaw using the expansion appliance before the adult teeth come in will increase levels of growth hormone in the body and improve the growth and development of children in general. This may happen because the expansion device changes the upper jaw that is attached to the nose and thus increases the nasal area for air intake. As such, the purpose of this study was to try to see if there may be a benefit to treating a crossbite before the adult teeth come in.
Who can participate?
Children aged between 7 and 10 years old who have irregularity in the width of the upper jaw
What does the study involve?
The study tests this by measuring levels of growth hormones in the blood. The stud team also want to verify if the breathing pattern is affected when expanding the upper jaw. This is measured by having children in the study do a sleep breathing test, where their breathing patterns and oxygen levels are measured while they sleep.
What are the possible benefits and risks of participating?
This study may benefit a child because there is evidence to suggest that the amount of air intake affects the amount of growth hormone in the body.
Where is the study run from?
Faculty of Medicine and Dentistry, University of Alberta (Canada)
When is the study starting and how long is it expected to run for?
January 2016 to December 2026
Who is funding the study?
Faculty of Medicine and Dentistry, University of Alberta (Canada)
Who is the main contact?
Prof. Manuel Lagravere (PI), manuel@ualberta.ca (Canada)
Contact information
Principal Investigator
11405 - 87 Avenue NW, 5th Floor
Edmonton
T6G 1C9
Canada
| Phone | +1 780 248-1122 |
|---|---|
| manuel@ualberta.ca |
Scientific
11400 University Ave
Edmonton
T6G 1Z1
Canada
| Phone | 587-937-4446 |
|---|---|
| abdelhay@ualberta.ca |
Study information
| Study design | Randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic, Home, Laboratory |
| Study type | Screening, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluation of oxygen saturation and serum levels of growth hormone and bone growth mediators after rapid maxillary expansion in growing patients |
| Study objectives | The evidence of metabolic and/or hormonal changes in patients after rapid maxillary expansion (RME) due to changes in the breathing pattern might open new points of view for diagnosis and treatment planning. This change in breathing pattern would be extrapolated by observing a reduction in apnoea/hypopnoea index (AHI) and an increase in oxygen saturation suggesting a shift from prevalent oral breathing to nasal breathing. This premise is based on that nasal breathing allows for greater oxygenation of the blood since it is more physiological than oral breathing. Moreover, a decrease in AHI suggests that nasal breathing is at least partially restored. By selecting the ones that improved and analyzing the metabolic effects changes in GH and other mediators in those cases it might improve our understanding of the systemic effects of maxillary expansion in growing individuals. |
| Ethics approval(s) | Approved 01/03/2016, University of Alberta, Health Research Ethics Board - Biomedical Panel (Research Ethics Office, 2-01 North Power Plant (NPP), Edmonton, Alberta T6N 2N2, Canada; +1 780 492 0459; reoffice@ualberta.ca), ref: Pro00061538 |
| Health condition(s) or problem(s) studied | Posterior crossbite |
| Intervention | The changes in growth hormone (GH) levels that the patients will show at the two timepoints will be first compared to a control group of the same age and this will allow the evaluation of significant cut-off levels. Moreover, GH levels at T1 and T2 will be compared to normal GH values at the same age and will be considered significant if higher than 2 standard deviations from normal increases for age and sex. The whole sample was divided into a treatment group and a control group according to a randomization list. Children in the control group will receive RME treatment after the end of the study interval time. Postponing treatment for the control group will not change the efficacy of treatment in this group since RME might be easily performed until mid palatal suture maturation at the pubertal growth spurt, which is a long way for the control group. Exclusion of patients in the pubertal growth spurt. Spontaneous growth hormone secretion increases during puberty in normal girls and boys. It has been shown that GH levels increase significantly during pubertal growth spurt. According to previous results the increase in mean levels was earlier in girls than boys, was most evident at night, and was due to increased pulse amplitude rather than a change in pulse frequency. Polysomnography (PSG) will consist of a take-home device which patients will use the first day and return to the doctor the following day. The data collected by the device will be analyzed by a specialized pediatrician. Blood samples will be collected and results will also be interpreted by a specialized pediatrician. In this interval, treatment group subjects will undergo RME and the control group will undergo no treatment. PSG exam will allow the exclusion of obstructive sleep apnea patients. Cone-beam computer tomographies (CBCT) will be obtained using the I-Cat New Generation (Imaging Science International, Hatfield, PA, USA). The image-taking protocol will use a large field of view 9in x 12in, 4 seconds, voxel size 0.30mm, 120 kVp, 23.87 mAS. Raw images will be exported into a DICOM file, which will be subsequently loaded into AVIZO software (version 8.1, Visualization Sciences Group, Burlington, MA, USA) for analysis. CBCTs will be taken at T0 and T1 being 12 months apart. Skeletal expansion before and after rapid maxillary expansion (RME) (12 months period) will be evaluated by plaster models and analyzing CBCT images. In order to determine reliability, ten random datasets will be measured by the principal investigator 3 times (with one-week intervals between measurements). Inter-reliability will be obtained by having three other investigators measure the datasets twice (one month between measurement trials). |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Upper jaw expansion orthodontic treatment |
| Primary outcome measure | Effects of rapid maxillary expansion on breathing measured by analyzing CBCTs, photos, airway measures and questionnaires at T0, T12 months and T End |
| Secondary outcome measures | Blood measurement of Serum bone alkaline phosphatase, calcium, phosphorus and Vitamin D levels using standard laboratory procedures at T0, T12 months and T End |
| Overall study start date | 15/01/2016 |
| Completion date | 24/12/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Good general health according to medical history and clinical examination 2. Maxillary transverse discrepancy (skeletal discrepancy) with or without unilateral posterior crossbite 3. Age between 7 and 10 years old (this age range was chosen to prevent bias in terms of pubertal peak growth since at this age it is assumed males and females have not had it yet) 4. Body mass index (BMI) is healthy (not below the 25th percentile and not above the 75th percentile) according to age. |
| Key exclusion criteria | Patients in the pubertal growth spurt |
| Date of first enrolment | 18/11/2016 |
| Date of final enrolment | 20/07/2026 |
Locations
Countries of recruitment
- Canada
- Italy
Study participating centres
Edmonton
T6G 1Z1
Canada
Varese
21100
Italy
Sponsor information
University/education
11400 University Avenue
Edmonton
T6G1Z1
Canada
| Phone | +1 780 407-5550 |
|---|---|
| ortho@ualberta.ca | |
| Website | http://ualberta.ca/ |
"ROR" |
https://ror.org/0160cpw27 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Faculty of Medicine & Dentistry - University of Alberta, University of Alberta Faculty of Medicine and Dentistry, Faculty of Medicine and Dentistry at University of Alberta, University of Alberta Faculty of Medicine & Dentistry, Faculty of Medicine & Dentistry - University of Alberta, University of Alberta Faculty of Medicine and Dentistry, FoMD
- Location
- Canada
Results and Publications
| Intention to publish date | 30/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal Shared in national and international conferences |
| IPD sharing plan | The dataset generated during and analyzed during the current study will be stored in a non-publicly available repository at University of Alberta. The type of data stored are blood measurement of serum bone alkaline phosphatase, calcium, phosphorus and Vitamin D. The process for requesting access is through Ethics Committee and custodian approvals. These data will be available at the end of the study. Consent from participants was required and obtained. Data will be stored with patients charts numbers. |
Editorial Notes
14/02/2025: The recruitment end date was changed from 01/11/2025 to 20/07/2026.
24/01/2025: The following changes were made to the study record:
1. The overall study end date was changed from 24/12/2025 to 24/12/2026.
2. The intention to publish date was changed from 30/07/2024 to 30/10/2025.
12/12/2023: The intention to publish date was changed from 31/12/2023 to 30/07/2024.
25/05/2023: Trial's existence confirmed by the University of Alberta, Health Research Ethics Board - Biomedical Panel (Canada).
