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NCT Number: NCT04988373

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

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.

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Key information

Conditions

Crowding of Anterior Mandibular Teeth

Age range

16 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Modified aligner appliance

Device

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

Traditional fixed appliance

Device

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

Primary outcomes

  1. Duration of Alignment

    Time frame: 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.

  2. Change in Little's Index of Irregularity

    Time frame: 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.

  3. Change in Lower Incisors Inclination

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2021
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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