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

NCT04866238 | Completed DMC

• 1 other identifier: UDDS-Ortho-04-2021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Teeth Crowding

Keywords

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

Outcome Measures

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.

  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

Study Arms (2)

Vestibular fixed appliances

ACTIVE COMPARATOR

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

Device: Vestibular fixed appliances

Clear aligners

EXPERIMENTAL

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

Device: Clear aligners

Interventions

Vestibular fixed appliances DEVICE

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

Vestibular fixed appliances

Clear aligners DEVICE

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

Clear aligners

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 26104387 BACKGROUND

• 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.

  PMID: 31391699 BACKGROUND

• 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.

  PMID: 9332805 BACKGROUND

• 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.

  PMID: 32340082 BACKGROUND

• 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.

  PMID: 17014535 BACKGROUND

• 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.

  PMID: 26589825 BACKGROUND

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Officials

• Samer T Jaber, DDS,MSc

  PhD student at the Orthodontic Department, University of Damascus

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS,MSc,PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 29, 2021
• Study Start: February 15, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 15, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)