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CompletedNCT04866238Updated Apr 29, 2021

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

An interventional study of Vestibular fixed appliances and Clear aligners in Teeth Crowding, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2021-04-29.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Feb 2019, registered Apr 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Teeth Crowding

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Keywords

  • Clear aligners
  • Oral health related quality of life
  • Orthodontic
  • Vestibular fixed appliances
  • Oral health impact profile
03

In context

Malocclusion

457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.

This study's enrollment of 36 is close to the median of 36 across 372 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Previous orthodontic treatment.
  • Subject with psychological abnormalities.
  • Subject with systemic diseases.
  • Subject has known allergy to latex and plastic
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    Vestibular fixed appliances

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

    Device: Vestibular fixed appliances

  • Experimental
    Clear aligners

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

    Device: Clear aligners

Interventions

  • DeviceVestibular 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.

  • DeviceClear aligners

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

06

What researchers measure

Primary outcomes

  1. 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.

    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

07

Study locations

1 site
  • Department of Orthodontics, University of Damascus Dental School
    Damascus, Syrian Arab Republic
08

References and documents

Publications

  • 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. PubMed 26104387 ↗
  • 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. PubMed 31391699 ↗
  • 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. PubMed 9332805 ↗
  • 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. PubMed 32340082 ↗
  • 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. PubMed 17014535 ↗
  • 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. PubMed 26589825 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04866238
Lead sponsor
Damascus University
Responsible party
Sponsor
First posted
Apr 29, 2021
Start date
Feb 15, 2019
Primary completion
Mar 12, 2020
Completion
Mar 15, 2021
Last update
Apr 29, 2021

Study contacts

Samer T Jaber, DDS,MSc
principal investigator · PhD student at the Orthodontic Department, University of Damascus
Mohammad Y Hajeer, DDS,MSc,PhD
study chair · Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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