The interrelationships between changes in the metabolic state and homeostasis of the bone and injection of a new substance during orthodontic tooth movement
| ISRCTN | ISRCTN99776766 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99776766 |
| Secondary identifying numbers | 4244 |
- Submission date
- 28/04/2024
- Registration date
- 07/05/2024
- Last edited
- 07/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Tooth anchorage control is one of the main factors determining the success of orthodontic treatment. The challenge is to design a system that maximizes desirable tooth movements and also minimizes anchorage loss, especially in adult patients demanding a more convenient treatment with orthodontic appliances to control unfavourable tooth movement. Bisphosphonate drugs may reduce orthodontic tooth movement due to their effects on bone turnover. Therefore, the aim of this study is to assess the use of the bisphosphonate drug zoledronic acid to prevent anchorage loss in orthodontic treatment.
Who can participate?
Patients aged 18-25 years old with skeletal class II malocclusion (overbite)
What does the study involve?
Patients will be randomly allocated into two groups to be treated with either zoledronic acid or placebo injection only once before starting the mass retraction, and are followed up until the retraction period ends (6-8 months).
What are the possible benefits and risks of participating?
Bisphosphonates can strengthen tooth anchorage during orthodontic treatment. Bisphosphonates may have side effects at high concentrations, which are not used 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?
April 2022 to June 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Fryal Rahme, fryalrahme3@gmail.com
Contact information
Public, Scientific
Department of Orthodontics
Faculty of Dentistry
Damascus University
Al-Mazzeh St
Damascus
0004
Syria
| Phone | +963 (0)99492798 |
|---|---|
| fryal3.rahme@damascusuniversity.edu.sy |
Scientific, Principal Investigator
Department of Orthodontics
Faculty of Dentistry
Damascus University
Al-Mazzeh St
Damascus
0004
Syria
 ORCID ID |
0000-0002-0727-2653 |
|---|---|
| Phone | +963 (0)944302075 |
| prof.ahmadburhan@damascusuniversity.edu.sy |
Study information
| Study design | Interventional single-center single-blinded randomized parallel-group controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Medical and other records, University/medical school/dental school |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluation of the efficacy of locally injected zoledronic acid in increasing the anchorage during en-masse retraction of the maxillary anterior teeth: a randomized controlled clinical trial |
| Study objectives | There are a significiant differences between the experimental group and the control group in increasing the anchorage during mass retraction of the upper anterior teeth. |
| Ethics approval(s) |
Approved 29/08/2022, Scientific research and postgraduate studies council of Damascus (Damascus, Damascus, 0004, Syria; +963 (0)993303359; ap.srd@damascusuniversity.edu.sy), ref: 4244 |
| Health condition(s) or problem(s) studied | Skeletal class II and moderate maxillary protrusion |
| Intervention | Patients will be randomly allocated into two groups using Microsoft® Excel electronic randomization: Group 1: Experimental group: the dental arch will first be aligned with wires 0.12, 0.14, 0.16, 16.22, 17.25, 19.25 NITI. Then the upper first premolars will be extracted and then will be applied the zoledronic acid to the patient through local injection mesial to the upper first molar on both the right and left sides and on the vestibular and palatal sides and then mass retraction of the upper anterior teeth will be started. Group 2: The treatment protocol used in this group is the same as described in the experimental group, but placebo will be applied to the patient instead of zoledronic acid. The medicinal substance is applied only once during the treatment before starting the mass retraction, and participants are followed up until the retraction period ends (6-8 months). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Zoledronic acid |
| Primary outcome measure | 1. The amount of slippage of the upper first molars mesially during retraction 2. The inclination of the axes of the upper first molars 3. Rotation of maxillary first molars 4. The height of the alveolar bone in the injection area 5. The thickness of the alveolar bone in the injection area 6. Root resorption of maxillary first molars Measured using cone beam computed tomography (CBCT) before the start of orthodontic treatment and after the end of the mass retraction |
| Secondary outcome measures | Pain and discomfort following injection measured using the visual analogue score (VAS) at baseline, 1, 3, and 7 days |
| Overall study start date | 01/04/2022 |
| Completion date | 20/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Patient who has a second class II as light to medium with 4<ANB<8 2. In the vertical plane, a natural or slight vertical growth pattern 3. Moderate anchorage, where the molar and canine relationships are cusp to cusp 4. The mandibular dental arch is well aligned or slightly crowed and does not require extraction treatment 5. A patient with good oral health and healthy periodontal tissue 6. A patient who does not take any medications 7. A patient who has not undergone previous orthodontic treatment |
| Key exclusion criteria | 1. Patients who have a severe structural defect in the sagittal plane 2. Patients who have a severe horizontal or vertical growth pattern 3. The patient who has moderate to severe crowding in the lower dental arch requires extraction to treat it 4. Patients with general diseases or craniofacial syndromes 5. Pregnant or breastfeeding |
| Date of first enrolment | 01/04/2023 |
| Date of final enrolment | 01/12/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Faculty of Dentistry
Al-Mazzeh St
Damascus
80789
Syria
Sponsor information
Research council
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 | 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
07/05/2024: Study's existence confirmed by Damascus University.
