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

Sponsor

Damascus University (Other)

Overall Status

Completed

CT.gov ID

NCT04866238

Collaborator

(none)

Enrollment

Location

Arms

24.9

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Teeth Crowding	Device: Vestibular fixed appliances Device: Clear aligners	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Feb 15, 2019

Actual Primary Completion Date :

Mar 12, 2020

Actual Study Completion Date :

Mar 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vestibular fixed appliances Adult patients in this group will be treated using fixed appliances.	Device: Vestibular fixed appliances The fixed appliances will be applied in class1 malocclusion patients who have dental crowding, then they will be followed up for 12 months.
Experimental: Clear aligners Adult patients in this group will be treated using clear aligners.	Device: Clear aligners The clear aligners will be applied in class1 malocclusion patients who have dental crowding, then they will be followed up for 12 months.

Arm

Intervention/Treatment

Active Comparator: Vestibular fixed appliances

Adult patients in this group will be treated using fixed appliances.

Device: Vestibular fixed appliances

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

Experimental: Clear aligners

Adult patients in this group will be treated using clear aligners.

Device: Clear aligners

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

Outcome Measures

Primary Outcome Measures

Changes in oral health related quality of life [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Orthodontics, University of Damascus Dental School	Damascus		Syrian Arab Republic

Sponsors and Collaborators

Damascus University

Investigators

Principal Investigator: Samer T Jaber, DDS,MSc, PhD student at the Orthodontic Department, University of Damascus
Study Chair: Mohammad Y Hajeer, DDS,MSc,PhD, Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria