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

Not Applicable

Completed

• Conditions: Crowding of Anterior Mandibular Teeth
• Interventions: Device: Modified aligner appliance; Device: Traditional fixed appliance

• Registration Number: NCT04988373
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study Start: 2021-07-23
• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-03
• Primary Completion: 2022-01-28
• Study Completion: 2022-09-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single aligner appliance	Modified aligner appliance	Modified aligner appliance with NiTi springs
Traditional fixed appliances	Traditional fixed appliance	MBT-prescription of metallic brackets.

Primary Outcome Measures

Name	Time	Method
Change in Lower Incisors Inclination	immediately before the start of orthodontic treatment; T1: at the end of the alignment stage which is expected to happen within 4 to 6 months	The angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured using Cephalometric x ray.
Duration of Alignment	The 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 months	The 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 Irregularity	T0: 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 months	The 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.

Trial Locations

Locations (1)

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