Skip to main content
OpenTrials
Completed

NCT Number: NCT04866238

Comparison of Oral Health Related Quality of Life Changes Between Clear Aligners and Vestibular Fixed Appliances

Patients who have severe crowding that required four premolars extraction will be treated in this study. The effects of clear aligners therapy on oral health related quality of life (OHRQoL) in comparison with vestibular fixed appliances using the validated OHIP-14 tool during orthodontic treatment. So the aim of the study was to compare the changes in OHRQoL between patients receiving clear aligners or fixed appliances during the first year of the orthodontic treatment.

There are two groups:

First group (Experimental): the patients in this group will be treated using clear aligners.

Second group (Control): the patients in this group will be treated using fixed appliances.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Teeth Crowding Behavior Crowding Spatial Behavior

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

For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the CAD/CAM technology, clear aligners treat a broader range of cases with greater precision. They consists of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Class I malocclusion with severe crowding (more than 5 mm of tooth-size-arch-length-discrepancy).
  • Good oral hygiene and periodontal health.
  • No congenitally missing or extracted teeth (except for the third molars).
  • No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion criteria

  • Previous orthodontic treatment.
  • Subject with psychological abnormalities.
  • Subject with systemic diseases.
  • Subject has known allergy to latex and plastic

Treatment and study plan

Vestibular fixed appliances

Device

The fixed appliances will be applied in class1 malocclusion patients who have dental crowding, then they will be followed up for 12 months.

Clear aligners

Device

The clear aligners will be applied in class1 malocclusion patients who have dental crowding, then they will be followed up for 12 months.

Primary outcomes

  1. Changes in oral health related quality of life

    Time frame: T0: immediately before the start of orthodontic treatment, T1: after 1 week, T2: after 2 weeks, T3: after 1 month, T4: after 6 months, T5: after 12 months

    Patients in both groups will be given a questionnaire to be filled. The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled in 3 minutes. OHIP-14 includes a subjective evaluation of the individual's oral health, functional well-being, emotional well-being, expectations and satisfaction with care and sense of self.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

The Effectiveness of Clear Aligners vs Fixed Appliances on Oral Health-related Quality of Life in Patients With Severe Crowding: A 12-months Randomized Controlled Clinical Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 29, 2021
Registry last updated
Apr 29, 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.

Related clinical trials

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