How orthodontic treatment without tooth removal affects dental alignment and bone structure
| ISRCTN | ISRCTN91404434 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91404434 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Damascus University |
| Funder | Damascus University |
- Submission date
- 23/08/2024
- Registration date
- 02/09/2024
- Last edited
- 02/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to explore the changes in teeth and surrounding bone when using a combination of a special orthodontic device (a modified lip bumper) and traditional braces to correct moderate crowding of the lower teeth. The goal is to see how this combination treatment affects the alignment of the teeth and the bone structure.
Who can participate?
Adults aged 18-27 years who have moderate crowding of the lower teeth are eligible to participate in this study.
What does the study involve?
Participants in the study will receive orthodontic treatment to correct their crowded teeth. They will either be treated with a combination of a modified lip bumper and traditional braces or with braces alone. The study will measure changes in the width of the dental arch and the surrounding bone structure during the treatment.
What are the possible benefits and risks of participating?
The combination treatment may help improve the way teeth move during orthodontic treatment, reducing some of the negative effects that can occur with tooth movement. There are no known risks associated with participating in this study.
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 December 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Moussab Allawe, moussab.allawe@damascusuniversity.edu.sy, moussab.allawe@gmail.com
Contact information
Public, Scientific, Principal investigator
Damascus University
Damascus
-
Syria
 ORCID ID |
0009-0003-4360-1279 |
|---|---|
| Phone | +963 938919767 |
| moussab.allawe@damascusuniversity.edu.sy |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | interventional two-arm randomized controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Dentoalveolar changes resulting from combination of modified lip bumper and fixed appliance -MBT prescription during the treatment of mandibular incisors crowding |
| Study objectives | Using a combination of fixed appilance and lip bumper will alter the type of orthodontic movement and reduce dentoalveolar side effects |
| Ethics approval(s) |
Approved 15/08/2022, Damascus University (Mazzeh highway, Damascus, -, Syria; +963 (11) 339 23223; ap.srd@damascusuniversity.edu.sy), ref: 4069 |
| Health condition(s) or problem(s) studied | Adult patients with moderate crowding in mandible |
| Intervention | Participants are assigned into the following two groups using simple randomization: Study group: fixed appliance _ MBT prescription_ and a modified lip bumper. Control group: fixed appliance _ MBT prescription_ only Each group will undergo leveling and alignment with the same archwire sequence The records (cast models and CBCT images) will be obtained at: T0: before treatment T1: after 12 month |
| Intervention type | Device |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Modified lip bumper |
| Primary outcome measure(s) |
Type of orthodontic movement determined upon cephalometric measurements, alveolar bone boundaries changes and root resorption determined on CBCT, arch dimensions changes detected on dental cast at T0: start of the treatment and T1: after one year |
| Key secondary outcome measure(s) |
1. Arch dimensions measured using dental casts at T0, T1 |
| Completion date | 15/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 27 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Adults 18 - 27 years 2. Mandibular crowding 4 - 6 mm 3. Normal or short face 4. No previous treatment |
| Key exclusion criteria | 1. Long face 2. Bad oral health 3. Drugs affect bone metabolism 4. Non compliant patients |
| Date of first enrolment | 04/09/2022 |
| Date of final enrolment | 01/10/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
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 during and/or analysed during the current study will be shared within planned publications. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/09/2024: Study's existence confirmed by Damascus University.
