Patient-centered Outcomes During Using Self-ligating Brackets With or Without Piezocision vs Traditional Brackets

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-14

Study Completion Date

2021-08-22

Brief Summary

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The different types of brackets (e.g., self-ligating and conventional brackets), and the various acceleration methods (e.g., corticotomy) cause varying degrees of pain and discomfort. This study will assess pain, discomfort, and other patient-centered outcomes in adults with severe crowding on the upper jaw requiring two first premolars extraction.

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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Detailed Description

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Pain associated with orthodontic treatment is one of the undesirable complications, which negatively affects the patient's cooperation. Pain may occur due to the pressure on the periodontal ligaments induced by orthodontic forces. The perception of pain is affected by many factors related to the patient, such as age, gender and any previous treatment experiences, which are negatively or positively reflected on the patient's cooperation. As for the factors related to the type of orthodontic treatment provided, the pain and discomfort are proportional to the brackets system used and the forces applied, especially in the leveling and alignment stage. The amount of tooth movement is directly affected by the friction between the brackets and the wires used. The physical properties of the wire and brackets used and the dimensions of the applied wires, in addition to the type of ligation play a significant role in the amount of friction generated.

Conditions

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Crowding, Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fixed appliance

Patients in this group will be treated using traditional brackets alone.

Group Type ACTIVE_COMPARATOR

Traditional braces

Intervention Type DEVICE

MBT 0.022 perception traditional braces will be used without any acceleration method.

Self-ligaton appliance

Patients in this group will be treated using self-ligating brackets alone.

Group Type EXPERIMENTAL

Self-ligating braces

Intervention Type DEVICE

MBT 0.022 perception Self-ligating braces will be used without any acceleration method.

Self-ligaton appliance + piezocision

Patients in this group will be treated using self-ligating brackets associated with piezocision.

Group Type EXPERIMENTAL

Self-ligating braces + piezocision

Intervention Type PROCEDURE

Flapless corticotomy will be applied for the upper anterior teeth.

Interventions

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Traditional braces

MBT 0.022 perception traditional braces will be used without any acceleration method.

Intervention Type DEVICE

Self-ligating braces

MBT 0.022 perception Self-ligating braces will be used without any acceleration method.

Intervention Type DEVICE

Self-ligating braces + piezocision

Flapless corticotomy will be applied for the upper anterior teeth.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. The patient's age is between 18 and 25 years
2. Severe crowding on the upper jaw (more than 6 mm) requires upper first premolars extraction
3. Little's Index of Irregularity is greater than 7 mm
4. Overbite ranging between 0-4 mm
5. Normal inclination of the upper incisors
6. No missing teeth (except for third molars)
7. Class I or class II (ANB ≤ 5) or class III (ANB ≥ 0)

Exclusion Criteria

1. The presence of any systemic disease affecting orthodontic movement
2. The presence of congenital syndromes or cleft lip and palate
3. Poor oral health with a plaque index greater than (1)
4. Skeletal maxillary constriction

Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No