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Evaluation of the Efficiency of Single Aligner Appliance for Treatment of Mild Crowding Cases in Adults.

Evaluation of the Efficiency of Modified Aligner Appliance With NiTi Springs for Treatment of Mild Crowding Cases in Adults.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04988373
Enrollment
36
Registered
2021-08-03
Start date
2021-07-23
Completion date
2022-09-20
Last updated
2024-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crowding of Anterior Mandibular Teeth

Keywords

Mild crowding, Aligner, Orthodontic treatment, Crowded anterior teeth

Brief summary

36 participants who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups. 1. In the experimental group, patients will be treated using single aligner appliance in order to align their crowding teeth. 2. Control group will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

Detailed description

Most adult patients do not prefer traditional fixed appliances for aesthetic reasons, long treatment duration, and relatively difficult oral care. The current study came in order to evaluate the Efficiency of a new single aligner appliance that is both aesthetic and economical.

Interventions

DEVICEModified aligner appliance

Patients will be treated using a single aligner appliance with NiTi Springs in order to align their crowding teeth.

Patients will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 28 Years
Healthy volunteers
No

Inclusion criteria

1. Adults patients aged between (16 - 28) years. 2. Class I malocclusion with Mild crowding (1 - 4) mm in the anterior region of the mandibular dental arch 3. All lower teeth are existed (except for third molars). 4. No congenitally missing or extracted teeth (except for third molars) 5. Patients have not undergone previous orthodontic treatment. 6. Patient with good oral hygiene (Plaque Index less than 1). 7. With no severe skeletal discrepancy.

Exclusion criteria

1. Bimaxillary dentoalveolar severe protrusion. 2. Any systemic diseases affect teeth movement. 3. Bad oral hygiene. 4. Patient lack of commitment toward follow-up appointments.

Design outcomes

Primary

MeasureTime frameDescription
Duration of AlignmentThe assessment is based on calculating days from the beginning of treatment till the end of the alignment stage which is expected to happen within 4 to 6 monthsThe time required in days will be calculated from the beginning of treatment till the end of the alignment stage.
Change in Little's Index of IrregularityT0: immediately before the start of orthodontic treatment; T1: after one month; T2: after two months; T3: after three months; T4: after four months; T5: at the end of the alignment stage (which is expected to occur within 4 to 6 monthsThe irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding. The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.
Change in Lower Incisors Inclinationimmediately before the start of orthodontic treatment; T1: at the end of the alignment stage which is expected to happen within 4 to 6 monthsThe angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured using Cephalometric x ray.

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026