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Completed

NCT Number: NCT04950829

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

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.

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Key information

Conditions

Crowding of Anterior Maxillary Teeth

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional brackets

Device

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.

Self-ligating brackets

Device

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.

Self-Ligating Brackets with flapless corticotomy

Procedure

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.

Primary outcomes

  1. Duration of teeth alignment

    Time frame: 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 outcomes

  1. The change in the plaque index.

    Time frame: 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.

  2. The change in the gingival index

    Time frame: 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 bleeding

  3. The change in papillary bleeding index.

    Time frame: 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.

  4. The change in the probing depth

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 6, 2021
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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