Evaluation of Self-ligating Brackets Plus Minor Surgery in Treating Crowded Cases of Malocclusion
- Conditions
- Malocclusion of Anterior Teeth
- Interventions
- Device: Self-Ligating BracketsDevice: Traditionally-Ligated BracketsProcedure: Corticotomy
- Registration Number
- NCT03647241
- Lead Sponsor
- Damascus University
- Brief Summary
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.
- Detailed Description
The sample of this study will be chosen according the following steps:
* The examination of patients referred to the Department of Orthodontics at the University of Damascus Dental School (clinical examination, diagnostic plaster models, radiographic photos , external and internal oral photographs) then subjects who meet the inclusion criteria will be included in this trial.
* A random sample of 100 patients from the sampling frame will be chosen.
* An information sheet ( including the research objective and treatment plan in detail ) will be given to each candidate. Then consent forms will be collected from those who agree to participate.
* A random selection of 60 patients will be performed. Then a random distribution of these patients to 3 groups will be done.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Age of patients: 17-28 years.
- Severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction.
- The Little's Index of Irregularity is over 7 mm.
- There is no previous orthodontic treatment.
- The patient dose not take any drug may interfere with the tooth movement (Cortisone, NSAIDs, ...).
- The patient has good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness (1963).
- Class I or mild class II (ANB ≤ 5) or mild class III (ANB ≥ 0) skeletal relationship.
- Overbite is between 0-4 mm.
- There is no skeletal constriction on the upper jaw.
- Full presence of all permanent teeth in the dental arch (except for third molars)
- Any systemic diseases that would affect tooth movement .
- Any congenital syndromes or cleft lip and palate cases
- Bad oral health
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self-Ligating Brackets Self-Ligating Brackets Patients will be treated using self-ligating brackets to achieve proper alignment of teeth Self-Ligating Brackets with Corticotomy Self-Ligating Brackets Patients will be treated using self-ligating brackets with corticotomy (alveolar cortical cuts) in order to accelerate orthodontic treatment. Self-Ligating Brackets with Corticotomy Corticotomy Patients will be treated using self-ligating brackets with corticotomy (alveolar cortical cuts) in order to accelerate orthodontic treatment. Traditionally-Ligated Brackets Traditionally-Ligated Brackets Patients in this group will be treated using traditionally-ligated brackets to achieve proper alignment of teeth
- Primary Outcome Measures
Name Time Method Change in Central Incisor Rotation Angle T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) 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.
Duration of Alignment This variable is going to be measured at the end of the alignment stage (i.e. expected to occur within four to six months) The time required in days will be calculated from the beginning of treatment till the end of the alignment stage
Change in Little's Index 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) 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.
Change in Canine Rotation Angle T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) 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.
Change in inter-canine width lingually T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) 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.
Change in inter-canine width T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) The distance between the cusp tips of the upper canines. This variable will be measured on plaster models.
Change in Lateral Incisor Rotation Angle T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Orthodontics, University of Damascus Dental School
🇸🇾Damascus, Syrian Arab Republic