Clinical trial NCT04866238: Comparison of Oral Health Related Quality of Life Changes Between Clear Aligners and Vestibular Fixed Appliances
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teeth Crowding
Keywords: Clear aligners
Oral health related quality of life
Orthodontic
Vestibular fixed appliances
Oral health impact profile
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in oral health related quality of life
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Damascus Dental School
Study officials:
affiliation: PhD student at the Orthodontic Department, University of Damascus
name: Samer T Jaber, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
name: Mohammad Y Hajeer, DDS,MSc,PhD
role: STUDY_CHAIR
References:
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citation: Zheng DH, Wang XX, Su YR, Zhao SY, Xu C, Kong C, Zhang J. Assessing changes in quality of life using the Oral Health Impact Profile (OHIP) in patients with different classifications of malocclusion during comprehensive orthodontic treatment. BMC Oral Health. 2015 Nov 20;15:148. doi: 10.1186/s12903-015-0130-7.