Malocclusion of Anterior Teeth Clinical Trial
Official title:
An Evaluation of the Efficacy of Self-Ligating Brackets Alone Or In Combination With Flapless Corticotomy In Leveling And Aligning Severely Crowded Dental Arches Compared With Conventional Brackets: A Randomized Clinical Controlled Trial
| Verified date | November 2020 |
| Source | Damascus University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be admitted then the initial diagnostic records (diagnostic gypsum samples - internal and external oral photographs as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched. The aim of this study is to compare three groups of patients with severe crowding of the upper anterior teeth: - Group 1 : Patients will be treated using self-ligating brackets - Group 2 : Patients will be treated using self-ligating brackets associated with flapless corticotomy. - Group 3 : Patients will be treated using traditional brackets (i.e. brackets positioned on the labial surface of the teeth) At the end of leveling and aligning phase, we will compare the self-ligating brackets and traditional brackets ( the acceleration of teeth movement, dental and alveolar changes and other variables ) Also, there is an intention to study the effectiveness of using flapless corticotomy with the self-ligating brackets.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | June 19, 2020 |
| Est. primary completion date | November 10, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 17 Years to 28 Years |
| Eligibility | Inclusion Criteria: 1. Age of patients: 17-28 years. 2. Severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction. 3. The Little's Index of Irregularity is over 7 mm. 4. There is no previous orthodontic treatment. 5. The patient dose not take any drug may interfere with the tooth movement (Cortisone, NSAIDs, ...). 6. The patient has good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness (1963). 7. Class I or mild class II (ANB = 5) or mild class III (ANB = 0) skeletal relationship. 8. Overbite is between 0-4 mm. 9. There is no skeletal constriction on the upper jaw. 10. Full presence of all permanent teeth in the dental arch (except for third molars) Exclusion Criteria: 1. Any systemic diseases that would affect tooth movement . 2. Any congenital syndromes or cleft lip and palate cases 3. Bad oral health |
| 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 Alignment | The time required in days will be calculated from the beginning of treatment till the end of the alignment stage | This variable is going to be measured at the end of the alignment stage (i.e. expected to occur within four to six months) | |
| Primary | Change in Little's Index | The irregularity of the upper and lower incisors is calculated by measuring the amount of deviation of the anatomic contact points between the six incisors in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). The more the score is, the more crowded the case is. | T0: one day before the beginning of treatment; T1: after one month; T2: after two months; T3: after three months; T4: after four months; T5: at the end of the alignment stage (which is expected to occur within 4 to 6 months) | |
| Primary | Change in inter-canine width lingually | The distance between the most lingual points on the lingual surface of the canines on the upper dental arch. This will be measured on plaster models. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) | |
| Primary | Change in inter-canine width | The distance between the cusp tips of the upper canines. This variable will be measured on plaster models. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) | |
| Primary | Change in Canine Rotation Angle | It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the canine. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) | |
| Primary | Change in Lateral Incisor Rotation Angle | It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the lateral incisor. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) | |
| Primary | Change in Central Incisor Rotation Angle | It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the central incisor. | T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) |