Making skeletal class III malocclusion treatment more effective by using a facemask and a modified skeletal expander
| ISRCTN | ISRCTN20427295 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20427295 |
| Secondary identifying numbers | 2620 |
- Submission date
- 20/01/2023
- Registration date
- 24/01/2023
- Last edited
- 30/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Skeletal class III malocclusion is a condition where the upper jaw is smaller than the lower jaw. This malocclusion is caused by a discrepancy in the size, shape, or position of the maxilla (upper jaw) and mandible (lower jaw) bones, and can lead to difficulty with biting and chewing, as well as visual appearance concerns. Rapid maxillary expansion and facial mask therapy is the most common treatment method for skeletal class III malocclusion in growing patients. Along with the effectiveness of this method, it has been associated with many side effects such as inclination movement of supporting teeth, and loss of height and thickness of the buccal bone. This trial aims to evaluate the effectiveness of buccal and labial pads in skeletal class III malocclusion treatment using a face mask appliance combined with rapid maxillary expansion. The purpose of buccal and labial acrylic pads is to remove the pressure applied to the maxillary from lips and cheeks and apply periosteal traction to stimulate the formation of the buccal bone.
Who can participate?
Children aged 7-10 years old with skeletal class III malocclusion
What does the study involve?
Patients will be randomly allocated into two groups:
Arm 1:
Experimental group: Each Patient in this group will be treated with a modified skeletal expander and face mask appliance.
*The expander used in this group was modified by adding buccal and labial acrylic pads.
Arm 2:
Controlled group: Each Patient in this group will be treated with a traditional skeletal expander and face mask appliance.
What are the possible benefits and risks of participating?
Using this modified device may improve the efficiency of skeletal Class III Malocclusion treatment. There are no expected risks of participating.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
April 2022 to June 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Ahmad Alhamwi, ahmad.hamwi.1996@gmail.com
Contact information
Scientific
Department of orthodontics
Faculty of Dentistry
Damascus University
Al-Mazzeh St.
Damascus
0004
Syria
 ORCID ID |
0000-0002-1919-033X |
|---|---|
| Phone | +963 993373851 |
| ahmad.alhamwi@damascusuniversity.edu.sy |
Scientific
Department of orthodontics
Faculty of Dentistry
Damascus University
Al-Mazzeh St.
Damascus
0004
Syria
| ORCID ID |
0000-0002-0727-2653 |
|---|---|
| Phone | +963 944302075 |
| dr.burhan-a@hotmail.com |
Study information
| Study design | Interventional single-center single-blinded randomized parallel-group controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Effectiveness of buccal and labial pads addition in improving the efficiency of skeletal class III malocclusion treatment using face mask appliance combined with rapid maxillary expansion: a randomized controlled clinical trial |
| Study hypothesis | 1. Using a modified skeletal expander improves the efficiency of treatment in the sagittal plane. 2. Using a modified skeletal expander improves the efficiency of treatment in the transverse plane. |
| Ethics approval(s) | Approved 09/05/2022, Scientific research and postgraduate studies council of Damascus University (Damascus, Syria 80789; +963 (0)993303359; ap.srd@damascusuniversity.edu.sy), ref: 2620 |
| Condition | Skeletal class III and maxillary transverse deficiency. |
| Intervention | Patients will be randomly allocated into two groups using Microsoft® Excel electronic randomization: Arm 1: Experimental group: Each Patient in this group will be treated with a modified skeletal expander and face mask appliance. The treatment will begin with the placement of bonded expander on the upper arch. The patients will be instructed to activate the expander twice a day until the desired transverse width is achieved (two weeks). 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. *The expander used in this group was modified by adding buccal and labial acrylic pads. Arm 2: Control group: Each Patient in this group will be treated with a traditional bonded skeletal expander and face mask appliance. The treatment protocol used in this group is the same as described in the experimental group. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Modified skeletal expander and face mask appliance with buccal and labial acrylic pads, traditional skeletal expander and face mask appliance |
| Primary outcome measure | 1. Sagittal and vertical skeletal changes before and after treatment will be assessed using cone-beam computed tomography-generated cephalograms. 2. Dentoalveolar changes including: 2.1. Upper incisor angle changes. 2.2. The permanent maxillary first molar inclination changes. 2.3. Height and thickness of alveolar bone. Dentoalveolar changes before and after treatment will be assessed using cone-beam computed tomography. |
| Secondary outcome measures | 1. Soft tissue changes before and after treatment will be assessed using profile photography. 2. Levels of pain and discomfort measured using a questionnaire given to the patients. |
| Overall study start date | 01/04/2022 |
| Overall study end date | 20/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 40 |
| Participant inclusion criteria | 1. Skeletal class III caused by maxillary deficiency with or without mandibular prognathism. 2. Maxillary transverse deficiency. 3. Patients with normal or horizontal growth patterns. 4. Patients in early mixed dentition (7-10 years old). |
| Participant exclusion criteria | 1. Patients with syndromes or craniofacial abnormalities. 2. Patients with vertical growth patterns. 3. Poor oral hygiene. 4. Previous orthodontic treatment. |
| Recruitment start date | 01/04/2023 |
| Recruitment end date | 01/12/2023 |
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://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 | 30/01/2025 |
|---|---|
| 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
30/01/2024: The following changes were made:
1. The public title was changed from "Making skeletal class III malocclusion (underbite) treatment more effective by using a facemask and a modified skeletal expander" to "Making skeletal class III malocclusion treatment more effective by using a facemask and a modified skeletal expander".
2. Device name was added.
3. The intention to publish date was changed from 30/06/2025 to 30/01/2025.
08/02/2023: The study setting has been changed from ‘Other’.
24/01/2023: Trial's existence confirmed by Damascus University
