Skip to main content
OpenTrials
Completed

NCT Number: NCT06401382

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Crowding of Anterior Mandibular Teeth

Age range

18 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

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Bimaxillary dentoalveolar protrusion.
  • Previous orthodontic treatment.
  • Severe skeletal discrepancy.

Treatment and study plan

A modified aligner appliance with NiTi springs

Device

The modified aligner appliance will be used until the final position is achieved.

Conventional fixed appliances

Device

The traditional fixed appliances with a standard prescription will be used.

Primary outcomes

  1. Changes in oral health related quality of life

    Time frame: T0: immediately before the start of orthodontic treatment; T1: after two weeks; T2: after one months; T3: after two months; T4: post-treatment

    Patients in both groups will receive a survey called the Oral-Health-Impact-Profile with 14 items (OHIP-14) to complete at every adjustment visit. The OHIP-14 questionnaire assesses various aspects of the individual's oral health, functional well-being, emotional well-being, expectations, and satisfaction with care, and sense of self through subjective evaluation. The total score can range from 0 to 56, with higher scores indicating poorer OHRQoL. Each domain within the OHIP-14 score is also rated on a scale of 0 to 8, with individual items contributing a score of 0 to 4.

Secondary outcomes

  1. Patient satisfaction with the progress of the treatment

    Time frame: At the end of treatment which is expected to occur within 4 to 6 months

    Patients in both groups will be asked one question about their satisfaction with the treatment's progress. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).

  2. Patient satisfaction with the appearance of the orthodontic appliance

    Time frame: At the end of treatment which is expected to occur within 4 to 6 months

    Patients in both groups will be asked one question about satisfaction with the appearance of the orthodontic appliance. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).

  3. Patient satisfaction with the results of the treatment

    Time frame: At the end of treatment which is expected to occur within 4 to 6 months

    Patients in both groups will be asked one question about their satisfaction with the treatment's results. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

The Impact of A Modified Aligner Appliance With NiTi Springs and Conventional Fixed Appliances on Oral Health-related Quality of Life in Patients With Mild Crowding

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 6, 2024
Registry last updated
May 6, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.