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

Crowding of Anterior Mandibular Teeth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06401382
• Other study ID #: UDDS-Ortho-2-2024
• Status: Completed
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: November 3, 2023

Study information

• Verified date: May 2024
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 3, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crowding of Anterior Mandibular Teeth

Intervention

Device:
• A modified aligner appliance with NiTi springs
The modified aligner appliance will be used until the final position is achieved.
• Conventional fixed appliances
The traditional fixed appliances with a standard prescription will be used.

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Orthodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient satisfaction with the progress of the treatment	Patients in both groups will be asked one question about their satisfaction with the treatment's progress. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).	At the end of treatment which is expected to occur within 4 to 6 months
Secondary	Patient satisfaction with the appearance of the orthodontic appliance	Patients in both groups will be asked one question about satisfaction with the appearance of the orthodontic appliance. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).	At the end of treatment which is expected to occur within 4 to 6 months
Secondary	Patient satisfaction with the results of the treatment	Patients in both groups will be asked one question about their satisfaction with the treatment's results. This question records satisfaction using a 100 mm visual analog scale (VAS). The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).	At the end of treatment which is expected to occur within 4 to 6 months