Crowding of Anterior Mandibular Teeth
Conditions
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.
Interventions
DEVICEA modified aligner appliance with NiTi springs
The modified aligner appliance will be used until the final position is achieved.
DEVICEConventional fixed appliances
The traditional fixed appliances with a standard prescription will be used.
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Syria
Outcome results
None listed