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

Not Applicable

Completed

• Conditions: Crowding of Anterior Mandibular Teeth
• Interventions: Device: A modified aligner appliance with NiTi springs; Device: Conventional fixed appliances

• Registration Number: NCT06401382
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study Start: 2022-06-02
• Primary Completion: 2023-02-13
• Study Completion: 2023-11-03
• Status Verified: 2024-05
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified aligner appliance with NiTi springs	A modified aligner appliance with NiTi springs	The patients in this group will be treated using a Modified aligner appliance with NiTi springs.
Conventional fixed appliances	Conventional fixed appliances	The patients in this group will be treated using conventional fixed appliances.

Primary Outcome Measures

Name	Time	Method
Changes in oral health related quality of life	T0: immediately before the start of orthodontic treatment; T1: after two weeks; T2: after one months; T3: after two months; T4: post-treatment	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with the progress of the treatment	At the end of treatment which is expected to occur within 4 to 6 months	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).
Patient satisfaction with the appearance of the orthodontic appliance	At the end of treatment which is expected to occur within 4 to 6 months	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).
Patient satisfaction with the results of the treatment	At the end of treatment which is expected to occur within 4 to 6 months	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).

Trial Locations

Locations (1)

Department of Orthodontics, University of Damascus Dental School; 🇸🇾 Damascus, Syrian Arab Republic