Patient-reported outcomes associated with face mask and rapid palatal expansion
| ISRCTN | ISRCTN12453635 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12453635 |
- Submission date
- 29/06/2025
- Registration date
- 01/07/2025
- Last edited
- 07/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Rapid maxillary expansion and facemask (RME/FM) are commonly used together for the orthopaedic treatment of growing Class III patients, whose lower teeth and jaw project further forward than the upper teeth and jaws. There are no studies in the medical literature that have examined patient-reported outcomes associated with treatment using RME/FM. This study aims to evaluate the patient-reported outcomes associated with the facemask and rapid palatal expansion.
Who can participate?
Patients in early mixed dentition (when both baby and permanent teeth are present in the mouth, 7-10 years old)
What does the study involve?
A standardised questionnaire was used to assess pain and functional impairment levels during the first 6 months of RME/FM treatment.
What are the possible benefits and risks of participating?
The study will provide information on the patient-reported outcomes associated with the facemask and rapid palatal expansion.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
May 2022 to February 2025
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Ahmad Alhamwi, ahmad.hamwi.1996@gmail.com
Contact information
Scientific, Principal Investigator
Department of Orthodontics
Faculty of Dentistry
Damascus University
Al-Mazzeh Street
Damascus
0004
Syria
 ORCID ID |
0000-0002-1919-033X |
|---|---|
| Phone | +963 (0)993373851 |
| ahmad.hamwi.1996@gmail.com |
Public, Scientific
Department of Orthodontics
Faculty of Dentistry
Damascus University
Al-Mazzeh Street
Damascus
0004
Syria
| ORCID ID |
0000-0002-0727-2653 |
|---|---|
| Phone | +963 (0)944302075 |
| dr.burhan-a@hotmail.com |
Study information
| Study design | Prospective clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | University/medical school/dental school |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Patient-reported outcomes of orthodontic treatment for skeletal Class III malocclusion using face mask with rapid palatal expansion: a prospective clinical trial |
| Study objectives | Using a face mask and rapid maxillary expansion (FM+RME) affects the patient-reported outcomes. |
| Ethics approval(s) |
Approved 17/05/2022, Scientific research and postgraduate studies council of Damascus University (Damascus University, Damascus, 80789, Syria; +963 (0)993303359; ap.srd@damascusuniversity.edu.sy), ref: 2622 |
| Health condition(s) or problem(s) studied | Skeletal class III malocclusion |
| Intervention | The treatment will begin with the placement of a bonded expander on the upper arch. The patients will be instructed to activate the expander once a day until the desired transverse width is achieved. The patients will be given facemasks immediately after the expansion ends and will be instructed to wear the appliance for a minimum of 14 hours per day. All patients will be treated at least to a positive, over-corrected dental overjet before discontinuing treatment with the facemask appliance. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Facemask + RME |
| Primary outcome measure | 1. Pain 2. Pressure 3. Difficulty in swallowing 4. Difficulty in speaking 5. Lack of confidence All outcomes were measured using the numeric rating scale (NRS) at 24 hours, 1 week, 2 weeks after activation of RME, and after 1 week, 1 month, 3 months and 6 months after facemask application. Participants were asked to rate their experience for each variable between 0 (least severity) and 10 (maximum severity) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 17/05/2022 |
| Completion date | 05/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 19 |
| Total final enrolment | 19 |
| Key inclusion criteria | 1. Skeletal class III caused by maxillary deficiency with or without mandibular prognathism 2. Patients with normal or horizontal growth patterns 3. Patients in early mixed dentition (7-10 years old) |
| Key exclusion criteria | 1. Patients with syndromes or craniofacial abnormalities 2. Patients with vertical growth patterns 3. Poor oral hygiene 4. Previous orthodontic treatment |
| Date of first enrolment | 20/05/2023 |
| Date of final enrolment | 07/01/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Faculty of Dentistry
Al-Mazzeh Street
Damascus
0004
Syria
Sponsor information
University/education
Mazzeh Street
Damascus
0004
Syria
| Phone | +963 (11) 339 23223 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | http://damasuniv.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 | 01/09/2025 |
|---|---|
| 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
07/07/2025: The target and final enrolment numbers were changed from 25 to 19.
30/06/2025: Study's existence confirmed by Damascus University.
