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

Not Applicable

Completed

• Conditions: Teeth Crowding
• Interventions: Device: Vestibular fixed appliances; Device: Clear aligners

• Registration Number: NCT04866238
• Lead Sponsor: Damascus University

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.

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 Timeline

• Study Start: 2019-02-15
• Primary Completion: 2020-03-12
• Study Completion: 2021-03-15
• Status Verified: 2021-04
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Study First Posted: 2021-04-29
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vestibular fixed appliances	Vestibular fixed appliances	Adult patients in this group will be treated using fixed appliances.
Clear aligners	Clear aligners	Adult patients in this group will be treated using clear aligners.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Orthodontics, University of Damascus Dental School; 🇸🇾 Damascus, Syrian Arab Republic