A new appliance to correct skeletal class II malocclusion in growing patients
| ISRCTN | ISRCTN15028527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15028527 |
| Secondary identifying numbers | 3891 |
- 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 of protocol
Background and study aims
Many pediatric patients suffer from a receding lower jaw, which affects the aesthetic appearance of the face. This study aims to advance the lower jaw by using a new device that advances the lower jaw and compares it to the commonly used twin block device.
Who can participate?
patients with class II malocclusion
What does the study involve?
The sample will be allocated randomly into two groups: the control group and the experimental group. The traditional twin-block appliance will be applied for the control group patients, while the esthetic twin-block appliance will be applied for the experimental group patients. Dentoskeletal and soft tissue changes and esthetic and functional effectiveness will be assessed using x-rays and photographs before and after treatment, and using a questionnaire.
What are the possible benefits and risks of participating?
The use of this device is accepted by patients as it is cosmetic, transparent, and does not involve risks.
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 Bahaa Joha, bahaa.joha@damascusuniversity.edu.sy
Contact information
Public, Scientific, Principal Investigator
Al-Mazzeh St
Damascus
80789
Syria
| Phone | +963 (0)934891818 |
|---|---|
| bahaa.joha@damascusuniversity.edu.sy |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation of the efficiency of the modified orthodontic removable traction appliance versus twin block appliance in the treatment of skeletal class II malocclusion |
| Study objectives | Null hypothesis: There are no statistically significant differences in the values of skeletal, dentoalveolar and soft tissue variables between the group treated with the removable orthodontic traction device and the control group. Alternative hypothesis: There are statistically significant differences in the values of skeletal, dentoalveolar and soft tissue variables between the group treated with the removable orthodontic traction device and the control group. |
| Ethics approval(s) |
Approved 25/07/2022, Scientific research and postgraduate studies council of Damascus University (-, Damascus, 80789, Syria; +963 (0)993303359; ap.srd@damascusuniversity.edu.sy), ref: 3891 |
| Health condition(s) or problem(s) studied | Skeletal class II malocclusion |
| Intervention | Randomization and sequence generation was done by one of the academic staff not involved in this study. With an allocation ratio of 1:1, a computer-generated list of random numbers was exported by Minitab® (version 17, Minitab, LLC, State College, PA). The allocation sequence was concealed using opaque, sealed, sequentially numbered envelopes opened only before the onset of the treatment. Patients will be randomly allocated into two groups: Arm 1: Experimental group: Each patient in this group will be treated with a modified orthodontic removable traction appliance. Arm 2: Controlled group: Each patient in this group will be treated with a twin-block appliance. The dentoskeletal and soft tissue changes and esthetic and functional efficacy will be assessed using cephalometric radiographs and profile photographs, pre and post-treatment, and a questionnaire. Changes for each group will be evaluated individually, and the two groups will be compared. Duration of treatment: 6-8 months. |
| Intervention type | Other |
| Primary outcome measure | 1. Dentoskeletal mandible changes as measured by tomographic: changes of the mandible before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs. Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1). 2. Dentoskeletal maxilla changes as measured by tomographic superimposition of the cranial base: changes of the maxilla before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs. Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1). 3. Soft tissue changes before and after treatment will be assessed and compared with those of the control group (facial convexity angle, nasolabial angle, Z-Merrifield angle etc) using profile photography. Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1). 4. The duration of functional treatment will be measured and compared between groups, after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months. |
| Secondary outcome measures | 1. Level of discomfort assessed using a questionnaire with a Visual Analog Scale (VAS) at baseline, 1 week, 3 months, end of treatment 2. Level of acceptance assessed using a questionnaire with a Visual Analog Scale (VAS) at baseline, 1 week, 3 months, end of treatment 3. Level of acceptance assessed using a questionnaire with a Visual Analog Scale (VAS) at baseline, 1 week, 3 months, end of treatment 4. Number of broken appliances counted until the end of treatment |
| Overall study start date | 20/06/2022 |
| Completion date | 10/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Angle class II malocclusion because of mandibular retrognathia 2. Overjet between upper and lower incisors (OJ) >5 3. Angle between (sn) anterior cranial base and b point in mandible jaw (SNB) <78 4. Patient during growth spurt 5. Normal or horizontal growth pattern Björk >402 |
| Key exclusion criteria | 1. Temporomandibular joint (TMJ) disorders 2. Poor oral hygiene 3. Previous orthodontic treatment. 4. Patients with syndromes, clefts, or craniofacial abnormalities. 5. Reason for contraindication of functional treatment |
| Date of first enrolment | 01/08/2022 |
| Date of final enrolment | 14/12/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
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 | 10/08/2024 |
|---|---|
| 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
24/10/2023: Study's existence confirmed by Damascus University.
