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

NCT ID: NCT04866238

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2021-03-15

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.

Conditions

Teeth Crowding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vestibular fixed appliances

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

Group Type: ACTIVE_COMPARATOR

Vestibular fixed appliances

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Clear aligners

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samer T Jaber, DDS,MSc

Role: PRINCIPAL_INVESTIGATOR

PhD student at the Orthodontic Department, University of Damascus

Mohammad Y Hajeer, DDS,MSc,PhD

Role: STUDY_CHAIR

Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Locations

Department of Orthodontics, University of Damascus Dental School

Damascus, , Syria

Countries

Syria

References

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Reference Type: BACKGROUND

PMID: 26104387 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Zhang B, Huang X, Huo S, Zhang C, Zhao S, Cen X, Zhao Z. Effect of clear aligners on oral health-related quality of life: A systematic review. Orthod Craniofac Res. 2020 Nov;23(4):363-370. doi: 10.1111/ocr.12382. Epub 2020 May 13.

Reference Type: BACKGROUND

PMID: 32340082 (View on PubMed)

Zhang M, McGrath C, Hagg U. The impact of malocclusion and its treatment on quality of life: a literature review. Int J Paediatr Dent. 2006 Nov;16(6):381-7. doi: 10.1111/j.1365-263X.2006.00768.x.

Reference Type: BACKGROUND

PMID: 17014535 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26589825 (View on PubMed)

Other Identifiers

UDDS-Ortho-04-2021

Identifier Type: -

Identifier Source: org_study_id