Muscular tension effect on the dental movement during the maxillary dental arch expansion - a randomized clinical controlled trial
| ISRCTN | ISRCTN69542858 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69542858 |
| Secondary identifying numbers | Funder ref: 501100020595 |
- Submission date
- 24/11/2023
- Registration date
- 27/11/2023
- Last edited
- 20/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Maxillary compression is a condition where the upper jaw has a misalignment, often leading to lateral crossbites. This can affect the dental arch in different ways. In orthodontic treatment for children, expanding the upper jaw is often necessary. This study aims to explore the treatment of maxillary compression in children using both basal and traditional removable plates.
Who can participate?
Children aged between 8 and 12 years old who require treatment for dentoalveolar maxillary compression
What does the study involve?
The patients will be randomly divided into two equal groups and a Master's student at the Orthodontics Department at Damascus University will apply the devices:
The first group (control) will be treated with a traditional expansion plate. The second group (experimental) will be treated with a basal expansion plate. The duration of treatment is 6 months.
What are the possible benefits and risks of participating?
The expected benefit is getting skeletal expansion without risks.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
November 2021 to October 2023
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Suzan Ibraheem, Suzan7Ibraheem@damascusuniversity.edu.sy (Syria)
Contact information
Public, Scientific, Principal Investigator
Al- Mazzeh street
Damascus
None available
Syria
| Phone | +963999328603 |
|---|---|
| suzan7.ibraheem@damascusuniversity.edu.sy |
Public
Al- Mazzeh street
Damascus
None available
Syria
| Phone | +963999328603 |
|---|---|
| suzanibraheem7@gmail.com |
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 |
| Participant information sheet | 44638_PIS.pdf |
| Scientific title | Slow maxillary expansion |
| Study hypothesis | There is no significant difference in skeletal and dentoalveolar changes betweem basal removable plate and traditional removable plate |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | Ethics approval was not required because the devices used are a mixture of previously used devices. Ref: No. /459/ dated 29/03/2022. |
| Condition | Treatment of maxillary compression in children |
| Intervention | The aim of this study was to investigate the effectiveness of a basal expansion plate compared to a traditional expansion plate in the treatment of maxillary compression. Simple randomization will be used by asking each participating patient to pick a piece of paper from an opaque plastic box, that contains 40 papers, half of them marked with the letter C, i.e., the control group (the control group treated with a traditional removable plate), and half are marked with the letter E, i.e., the experimental group (the experimental group treated with a basal removable plate). The duration of treatment is 6 months The intervention provider was a Master's Degree student at the Department of Orthodontics The modes of delivery were face-to-face and it was provided individually. All interventions were at the Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dentistry -Damascus University. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Traditional removable maxillary compression plate, basal removable maxillary compression plate |
| Primary outcome measure | Skeletal and dentoalveolar changes measured using frontal and lateral cephalometric photos and cast models at the beginning of treatment and after 6 months |
| Secondary outcome measures | Tension, pressure, pain, lack of confidence, swallowing difficulties and speech difficulties measured using a Numerical Rating Scale (NRS) after one week, one month, 3 months and 6 months |
| Overall study start date | 15/11/2021 |
| Overall study end date | 17/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | Two groups, each group contain 20 patients |
| Total final enrolment | 42 |
| Participant inclusion criteria | 1. Patients in the mixed dentition 2. Chronological age between 8 and 12 years old 3. Dentoalveolar maxillary constriction 4. Dental and skeletal class I and II malocclusion 5. The presence of upper first permanent molars 6. No systematic diseases 7. Good oral health |
| Participant exclusion criteria | 1. Constriction in the anterior region 2. Presence of general diseases, syndromes, or cleft lip and palate 3. Patients with previous orthodontic treatment |
| Recruitment start date | 15/11/2022 |
| Recruitment end date | 15/04/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
Syria
Sponsor information
University/education
Albaramkeh
Damascus
-
Syria
| Phone | +963(11)223-2152 |
|---|---|
| Damascusuniversity@edu.sy.com | |
| Website | http://www.damascusuniversity.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 | 15/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 27/11/2023 | No | Yes |
Additional files
Editorial Notes
20/09/2024: The following changes were made to the trial record:
1. The public title was changed from "Slow maxillary expansion" to "Muscular tension effect on the dental movement during the maxillary dental arch expansion - A Randomized Clinical Controlled Trial".
2. The scientific title was changed from "Muscular tension effect on the dental movement during the maxillary dental arch expansion - A Randomized Clinical Controlled Trial" to "Slow maxillary expansion".
04/12/2023: Internal review.
27/11/2023: Study's existence confirmed by the Syrian Arab Republic, Damascus University, President of the University (Syria).
