Efficacy and Periodontal Parameters in Self-ligating Brackets Alone or With Corticotomy vs Conventional Brackets

Study Overview
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Brief Summary
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Patients who have severe crowding on the upper jaw that requires two first premolars extraction will be enrolled in this trial. The different types of brackets, such as self-ligating brackets and conventional brackets, and the various acceleration methods, such as corticotomy, have different effects on the orthodontic treatment time and the periodontal tissues. So, this study will assess and compare the overall leveling and aligning time and the changes in periodontal indices between patients with severe crowding, treating with self-ligating brackets associated with flapless corticotomy versus conventional brackets alone versus self-ligating brackets alone. There are three groups: The first group (control group): the patients in this group will be treated using conventional brackets alone. The second group (Experimental group): the patients in this group will be treated using self-ligating brackets alone. The third group (Experimental group): the patients in this group will be treated using self-ligating brackets associated with flapless corticotomy.

Detailed Description
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The prolonged duration of the treatment period can cause many problems such as caries and periodontal diseases. The oral environment is considered a suitable environment for many germs and microorganisms to grow. Any increase in the percentage of these germs predisposes to the occurrence of dental and periodontal problems. Several studies have used various procedures and many types of brackets to accelerate dental movement in order to reduce treatment time. Orthodontic treatment using different devices usually contributes to change the nature of the oral environment and its contents of microorganisms Many bracket systems have been used, such as the conventional brackets and self-ligating brackets. The use of self-ligating brackets has increased significantly in recent years. The absence of wired or elastic elements may cause less accumulation of plaque.

Official Title
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Evaluation of Leveling and Alignment Time and the Periodontal Status in Patients With Severe Upper Crowding Treated by Flapless Corticotomy-assisted Self-ligating Brackets in Comparison With Conventional or Self-Ligating Brackets Alone

Conditions
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Crowding of Anterior Maxillary Teeth

Intervention / Treatment
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* Device: Conventional brackets
* Device: Self-ligating brackets
* Procedure: Self-Ligating Brackets with flapless corticotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sever crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires extraction of two upper premolars. The Little's Index of Irregularity is more than 7 mm. Good oral health (plaque Index is less or equal to 1). Class I or class II (ANB ≤ 5) or class III (ANB ≥ 0). Overbite is between 0-4 mm. No skeletal constriction on the upper jaw. No congenitally missing or extracted teeth (except for the third molars). Exclusion Criteria: Any systemic diseases affect teeth movement. Any congenital syndromes or cleft lip and palate. Bad oral health. The patient is not committed to periodic follow-up times.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional brackets<br>Patients will receive an orthodontic treatment using conventional brackets until achieving appropriate alignment of the upper anterior teeth. | Device: Conventional brackets<br>* These brackets are used in a conventional way, where the orthodontist used to apply elastic parts to engage the arch to the slot of the brackets.<br>|
| Experimental: Self-ligating brackets<br>Patients will receive an orthodontic treatment using self-ligating brackets until achieving appropriate alignment of the upper anterior teeth. | Device: Self-ligating brackets<br>* These brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets.<br>|
| Experimental: 3- Self-Ligating brackets with fapless corticotomy<br>Patients will receive an orthodontic treatment using self-ligating brackets with corticotomy until achieving appropriate alignment of the upper anterior teeth. | Procedure: Self-Ligating Brackets with flapless corticotomy<br>* These brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets. Flapless corticotomy will be performed in order to stimulate acceleration in tooth movement during the orthodontic treatment in this group only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of teeth alignment | The number of days required to finish the alignment stage of upper teeth will be calculated from the beginning of treatment till the end of the alignment stage (i.e. teeth alignment is achieved) | This will be measured immediately at the end of the alignment stage; this is expected to be within 180 to 200 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the plaque index. | Assessment will be achieved using a gingival probe according to Silness and Loe (1964). A. (0) = No plaque. B. (1) = A film of plaque stick to the free gingival margin and adjacent area of the tooth. C. (2) = Moderate accretion of soft deposits on the tooth and gingival margin or within the gingival pocket. D. (3) = Abundance of soft material on the tooth and gingival margin and/or within the gingival pocket. | T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months | 
| The change in the gingival index | Assessment will be achieved using a gingival probe according to Silness and Loe (1964). A. (0) = Normal gingiva. B. (1) = Mild inflammation: minor change in color, slight oedema. No bleeding on probing. C. (2) = Moderate inflammation: redness, oedema and glazing and bleeding on probing. D. (3) = Sever inflammation: marked redness and oedema, ulceration, and tendency to spontaneous bleeding | T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months | 
| The change in papillary bleeding index. | Assessment will be achieved using a gingival probe according to Muhlemann (1977). A. (0) = No bleeding. B. (1) = A single discreet bleeding point appears. C. (2) = Several isolated bleeding points or a single fine line of blood appears. D. (3) = The interdental triangle fills with blood shortly after probing. E. (4) = Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus. | T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months | 
| The change in the probing depth | Assessment will be achieved using a gingival probe according to Miller (1985) It will be measured clinically as the distance from the free gingival margin to the gingival sulcus. | T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months |