Efficacy and Periodontal Parameters in Self-ligating Brackets Alone or With Corticotomy vs Conventional Brackets
- Conditions
- Crowding of Anterior Maxillary Teeth
- Interventions
- Procedure: Self-Ligating Brackets with flapless corticotomyDevice: Conventional bracketsDevice: Self-ligating brackets
- Registration Number
- NCT04950829
- Lead Sponsor
- Damascus University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3- Self-Ligating brackets with fapless corticotomy Self-Ligating Brackets with flapless corticotomy Patients will receive an orthodontic treatment using self-ligating brackets with corticotomy until achieving appropriate alignment of the upper anterior teeth. Conventional brackets Conventional brackets Patients will receive an orthodontic treatment using conventional brackets until achieving appropriate alignment of the upper anterior teeth. Self-ligating brackets Self-ligating brackets Patients will receive an orthodontic treatment using self-ligating brackets until achieving appropriate alignment of the upper anterior teeth.
- Primary Outcome Measures
Name Time Method Duration of teeth alignment This will be measured immediately at the end of the alignment stage; this is expected to be within 180 to 200 days 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)
- Secondary Outcome Measures
Name Time Method The change in the plaque index. T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months 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.The change in papillary bleeding index. T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months 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.The change in the gingival index T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months 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 bleedingThe change in the probing depth T0: immediately before applying the fixed appliance; T1: after 1 month; T2: after 2 months, T3: after 3 months, T4: after 6 months 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.
Trial Locations
- Locations (1)
Department of Orthodontics, University of Damascus Dental School
🇸🇾Damascus, Syrian Arab Republic