Oral Health-Related Quality of Life Between Two Different Types of Orthodontic Appliances

Damascus University

Status: Completed

Conditions: Crowding of Anterior Mandibular Teeth

Treatments: Device: A modified aligner appliance with NiTi springs; Device: Conventional fixed appliances

Study type: Interventional

Funder types: Other

Identifiers

NCT06401382

UDDS-Ortho-2-2024

Details and patient eligibility

About

Patients who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be treated in this trial. The effects of modified aligner appliance with NiTi springs on oral health-related quality of life (OHRQoL) compared with conventional fixed appliances using the OHIP-14 questionnaire during orthodontic treatment. So, this study aims to compare the changes in OHRQoL between patients receiving modified aligner appliances or conventional fixed appliances during orthodontic treatment.

There are two groups:

1. Experimental group: the patients in this group will be treated using a modified aligner appliance.
2. Control group: the patients in this group will be treated using conventional fixed appliances

Full description

Most adult patients do not choose traditional fixed appliances due to concerns about appearance, lengthy treatment time, and challenges with oral hygiene. This study aimed to assess the impact on psychological well-being, aesthetics, and functionality of a novel single aligner appliance.

Enrollment: 36 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged between (18 - 25) years.
2. Mild crowding < 4 mm in the lower dental arch with class I malocclusion
3. No congenitally missing or extracted teeth (except for third molars)
4. Patients with good oral hygiene.

Exclusion criteria

1. Bimaxillary dentoalveolar protrusion.
2. Previous orthodontic treatment.
3. Severe skeletal discrepancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Modified aligner appliance with NiTi springs

Experimental group

Description:

The patients in this group will be treated using a Modified aligner appliance with NiTi springs.

Treatment:

Device: A modified aligner appliance with NiTi springs

Conventional fixed appliances

Active Comparator group

Description:

The patients in this group will be treated using conventional fixed appliances.

Treatment:

Device: Conventional fixed appliances