Clinical trial NCT06401382: Oral Health-Related Quality of Life Between Two Different Types of Orthodontic Appliances
Official title: The Impact of A Modified Aligner Appliance With NiTi Springs and Conventional Fixed Appliances on Oral Health-related Quality of Life in Patients With Mild Crowding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crowding of Anterior Mandibular Teeth
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Most adult patients do not choose traditional fixed appliances due to concerns about appearance, lengthy treatment time, and challenges with oral hygiene. This study aimed to assess the impact on psychological well-being, aesthetics, and functionality of a novel single aligner appliance.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Bimaxillary dentoalveolar protrusion.
2. Previous orthodontic treatment.
3. Severe skeletal discrepancy.

Primary outcomes:
measure: Changes in oral health related quality of life
timeFrame: 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:
measure: Patient satisfaction with the progress of the treatment
timeFrame: At the end of treatment which is expected to occur within 4 to 6 months
measure: Patient satisfaction with the appearance of the orthodontic appliance
timeFrame: At the end of treatment which is expected to occur within 4 to 6 months
measure: Patient satisfaction with the results of the treatment
timeFrame: At the end of treatment which is expected to occur within 4 to 6 months
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Damascus Dental School
Study officials:
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
name: Ziad Mohamad Alhafi, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University
name: Nada Rajeh, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University
name: Mohammad Younis Hajeer, DDS MSc PhD
role: STUDY_CHAIR
References:
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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.
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citation: 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.
citation: 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.
citation: 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.