Impaction of Tooth Clinical Trial
Official title:
Evaluation of the Efficiency of Minimally-invasive Surgically-assisted Withdrawal of Palatally Impacted Maxillary Canines in Terms of Movement Velocity and Dento-alveolar Changes: A Randomized Controlled Clinical Trial
| Verified date | February 2023 |
| Source | Damascus University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Impacted canine causes many problems for patients, such as absorption and damages to the adjacent teeth roots, as well as aesthetic problems. Correction of this problem requires a lengthy time. Therefore, many methods have been suggested to accelerate the movement of impacted canines with the help of surgical procedures.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | February 5, 2023 |
| Est. primary completion date | June 20, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years to 30 Years |
| Eligibility | Inclusion Criteria: 1. Palatal or Mid-alveolar impacted canine. 2. There is no previous orthodontic treatment. 3. Healthy periodontal tissues and good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness(1963)). 4. No consumption of any drug that may interfere with the tooth movement (Cortisone, NSAIDs, …). 5. Mild or no crowding in the upper jaw. 6. No history of previous trauma to the maxillofacial region or surgical interventions. Exclusion Criteria: 1. Any systemic diseases that would affect tooth movement 2. Antidepressant prevents oral surgery 3. Any congenital syndromes or cleft lip and palate cases 4. Bad oral health 5. Previous orthodontic treatment |
| Country | Name | City | State |
|---|---|---|---|
| Syrian Arab Republic | Department of Orthodontics, University of Damascus Dental School | Damascus |
| Lead Sponsor | Collaborator |
|---|---|
| Damascus University |
Syrian Arab Republic,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Duration of Canine Traction | The time required in days will be calculated from the beginning of canine traction till the end of canine alignment in its place in the dental arch. | The required time (in days) to achieve complete alignment of the impacted canine will be calculated which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group | |
| Primary | Change in Canine Location in the Axial View | The distance between the cusp tip of the impacted canine to the palatal mid-line in the axial view using cone-beam computed tomography (CBCT) imaging. | T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group. | |
| Primary | Change in Canine Inclination in the Coronal View | The mesiodistal inclination of the impacted canine will be calculated which is the angle between the long axis of the impacted canine and the mid-sagittal plane in the coronal view of the cone-beam computed tomography (CBCT) imaging. | T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group. | |
| Primary | Change in the Canine Inclination in the Sagittal View | The labiopalatal inclination of the impacted canine: will be calculated which is the angle between the long axis of the impacted canine and a line perpendicular to the horizontal plane in the sagittal view of the cone-beam computed tomography (CBCT) imaging. | T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group. | |
| Primary | Change in the 3D Canine Location | The vertical distance from the cusp tip of the impacted canine to the upper occlusion plane is measured using the 3D volumetric rendered model of the cone-beam computed tomography (CBCT) imaging. | T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group. | |
| Primary | Relation to adjacent teeth | The contact between the impacted canine and the central and/or the lateral incisor will be evaluated by looking at the shortest distance between the impacted canine crown and the adjacent incisors' roots This will be done using sequential axial views on the cone-beam computed tomography (CBCT) imaging. | Just one day before the beginning of treatment | |
| Primary | Change in the Absorption to the adjacent roots | Absorption of adjacent roots will be evaluated as follows: In the axial views: an estimation of root damage will be taken into account and will be combined with an estimation of the vertical root damage using 3D volumetric rendered models and then will be classified into one of the four categories Class I: cementum involvement only and located at the apical third of the root Class II: involvement reaching the dentin but vertically less than one-third of the root length. Class III: involvement reaching the dentin and partially the pulp but still vertically less than one-third of the root length. Class IV: involvement reaching the root pulp and damaging more than one third of the root length vertically. |
T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group. |