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

Damascus University

Status: Completed

Conditions: Crowding, Tooth

Treatments: Device: Self-ligating braces; Device: Traditional braces; Procedure: Self-ligating braces + piezocision

Study type: Interventional

Funder types: Other

Identifiers

NCT05416242

UDDS-Ortho-11-2022

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 28 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 3 patient groups

Fixed appliance

Active Comparator group

Description:

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

Treatment:

Device: Traditional braces

Self-ligaton appliance

Experimental group

Description:

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

Treatment:

Device: Self-ligating braces

Self-ligaton appliance + piezocision

Experimental group

Description:

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

Treatment:

Procedure: Self-ligating braces + piezocision