Oral Health-Related Quality of Life Between Two Different Types of Orthodontic Appliances

NCT06401382 | Completed DMC

• 1 other identifier: UDDS-Ortho-2-2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be treated in this trial. The effects of modified aligner appliance with NiTi springs on oral health-related quality of life (OHRQoL) compared with conventional fixed appliances using the OHIP-14 questionnaire during orthodontic treatment. So, this study aims to compare the changes in OHRQoL between patients receiving modified aligner appliances or conventional fixed appliances during orthodontic treatment. There are two groups:

1. 1.Experimental group: the patients in this group will be treated using a modified aligner appliance.
2. 2.Control group: the patients in this group will be treated using conventional fixed appliances

Conditions

Crowding of Anterior Mandibular Teeth

Outcome Measures

Primary Outcomes (1)

• Changes in oral health related quality of life

  Patients in both groups will receive a survey called the Oral-Health-Impact-Profile with 14 items (OHIP-14) to complete at every adjustment visit. The OHIP-14 questionnaire assesses various aspects of the individual's oral health, functional well-being, emotional well-being, expectations, and satisfaction with care, and sense of self through subjective evaluation. The total score can range from 0 to 56, with higher scores indicating poorer OHRQoL. Each domain within the OHIP-14 score is also rated on a scale of 0 to 8, with individual items contributing a score of 0 to 4.

  T0: immediately before the start of orthodontic treatment; T1: after two weeks; T2: after one months; T3: after two months; T4: post-treatment

Secondary Outcomes (3)

• Patient satisfaction with the progress of the treatment

  At the end of treatment which is expected to occur within 4 to 6 months

• Patient satisfaction with the appearance of the orthodontic appliance

  At the end of treatment which is expected to occur within 4 to 6 months

• Patient satisfaction with the results of the treatment

  At the end of treatment which is expected to occur within 4 to 6 months

Study Arms (2)

Modified aligner appliance with NiTi springs

EXPERIMENTAL

The patients in this group will be treated using a Modified aligner appliance with NiTi springs.

Device: A modified aligner appliance with NiTi springs

Conventional fixed appliances

ACTIVE COMPARATOR

The patients in this group will be treated using conventional fixed appliances.

Device: Conventional fixed appliances

Interventions

A modified aligner appliance with NiTi springs DEVICE

The modified aligner appliance will be used until the final position is achieved.

Modified aligner appliance with NiTi springs

Conventional fixed appliances DEVICE

The traditional fixed appliances with a standard prescription will be used.

Conventional fixed appliances

Eligibility Criteria

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

You may qualify if:

• Patients aged between (18 - 25) years.
• Mild crowding \< 4 mm in the lower dental arch with class I malocclusion
• No congenitally missing or extracted teeth (except for third molars)
• Patients with good oral hygiene.

You may not qualify if:

• Bimaxillary dentoalveolar protrusion.
• Previous orthodontic treatment.
• Severe skeletal discrepancy.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

Location

Related Publications (7)

• 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

• Masood Y, Masood M, Zainul NN, Araby NB, Hussain SF, Newton T. Impact of malocclusion on oral health related quality of life in young people. Health Qual Life Outcomes. 2013 Feb 26;11:25. doi: 10.1186/1477-7525-11-25.

  PMID: 23443041 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

• 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

• Kara-Boulad JM, Burhan AS, Hajeer MY, Khattab TZ, Nawaya FR. Evaluation of the Oral Health-Related Quality of Life (OHRQoL) in Patients Undergoing Lingual Versus Labial Fixed Orthodontic Appliances: A Randomized Controlled Clinical Trial. Cureus. 2022 Mar 22;14(3):e23379. doi: 10.7759/cureus.23379. eCollection 2022 Mar.

  PMID: 35371870 BACKGROUND

• Feu D, Oliveira BH, Celeste RK, Miguel JA. Influence of orthodontic treatment on adolescents' self-perceptions of esthetics. Am J Orthod Dentofacial Orthop. 2012 Jun;141(6):743-50. doi: 10.1016/j.ajodo.2011.12.025.

  PMID: 22640676 BACKGROUND

• Palomares NB, Celeste RK, Oliveira BH, Miguel JA. How does orthodontic treatment affect young adults' oral health-related quality of life? Am J Orthod Dentofacial Orthop. 2012 Jun;141(6):751-8. doi: 10.1016/j.ajodo.2012.01.015.

  PMID: 22640677 BACKGROUND

Study Officials

• Ziad Mohamad Alhafi, DDS MSc

  Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Nada Rajeh, DDS MSc PhD

  Department of Orthodontics, Faculty of Dentistry, Damascus University

  STUDY DIRECTOR

• Mohammad Younis Hajeer, DDS MSc PhD

  Department of Orthodontics, Faculty of Dentistry, Damascus University

  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: May 2, 2024
• First Posted: May 6, 2024
• Study Start: June 2, 2022
• Primary Completion: February 13, 2023
• Study Completion: November 3, 2023
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)