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

Primary Purpose

Teeth Crowding

Status

Completed

Phase

Not Applicable

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

Vestibular fixed appliances

Clear aligners

About this trial

This is an interventional treatment trial for Teeth Crowding focused on measuring Clear aligners, Oral health related quality of life, Orthodontic, Vestibular fixed appliances, Oral health impact profile

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Department of Orthodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vestibular fixed appliances

Clear aligners

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in oral health related quality of life

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04866238

First Posted

April 27, 2021

Last Updated

April 27, 2021

Sponsor

Damascus University

1. Study Identification

Unique Protocol Identification Number

NCT04866238

Brief Title

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

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

February 15, 2019 (Actual)

Primary Completion Date

March 12, 2020 (Actual)

Study Completion Date

March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Teeth Crowding

Keywords

Clear aligners, Oral health related quality of life, Orthodontic, Vestibular fixed appliances, Oral health impact profile

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vestibular fixed appliances

Arm Type

Active Comparator

Arm Description

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

Arm Title

Clear aligners

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Vestibular fixed appliances

Intervention Description

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

Intervention Name(s)

Clear aligners

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in oral health related quality of life

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samer T Jaber, DDS,MSc

Organizational Affiliation

PhD student at the Orthodontic Department, University of Damascus

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohammad Y Hajeer, DDS,MSc,PhD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Orthodontics, University of Damascus Dental School

City

Damascus

Country

Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26104387

Citation

Azaripour A, Weusmann J, Mahmoodi B, Peppas D, Gerhold-Ay A, Van Noorden CJ, Willershausen B. Braces versus Invisalign(R): gingival parameters and patients' satisfaction during treatment: a cross-sectional study. BMC Oral Health. 2015 Jun 24;15:69. doi: 10.1186/s12903-015-0060-4.

Results Reference

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PubMed Identifier

31391699

Citation

Demirovic K, Habibovic J, Dzemidzic V, Tiro A, Nakas E. Comparison of Oral Health-Related Quality of Life in Treated and Non-Treated Orthodontic Patients. Med Arch. 2019 Apr;73(2):113-117. doi: 10.5455/medarh.2019.73.113-117.

Results Reference

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PubMed Identifier

9332805

Citation

Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

Results Reference

background

PubMed Identifier

32340082

Citation

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.

Results Reference

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PubMed Identifier

17014535

Citation

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.

Results Reference

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PubMed Identifier

26589825

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.

Results Reference

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

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